Dry Eye
Conditions
Brief summary
The objective of this study was to compare the safety and efficacy of 0.10% and 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
Interventions
BIOLOGICALHL036 ophthalmic solution
HL036 ophthalmic solution
OTHERPlacebo vehicle solution
Placebo vehicle solution
Sponsors
HanAll BioPharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a patient-reported history of dry eye for at least 6 months prior to enrollment * Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1 * Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2
Exclusion criteria
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1 * Have used Restasis® or Xiidra® within 60 days of Visit 1 * Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study) * Have an uncontrolled systemic disease * Be a woman who is pregnant, nursing or planning a pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coprimary Endpoint: Change From Baseline in Inferior Corneal Staining Score to Day 57 (Pre-CAE) | Baseline (Day 1 Pre-CAE), Day 57 (Pre-CAE) | It was evaluated for the inferior region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. |
| Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) | Baseline (Day 1 Pre-CAE), Day 57 (Pre-CAE) | It is assessed by the Ora Calibra® Ocular Discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe) with 1 point increments, where lower scores indicate improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Fluorescein Staining (Central Region) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It is evaluated for the central region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It is evaluated for the nasal region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It is evaluated for the temporal region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Corneal sum score is the sum of all regions of the cornea (inferior, superior and central regions). Individual region score was evaluated on the Ora Calibra® Corneal and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Corneal sum score ranges from 0 to 12. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Conjunctival sum score is the sum of all regions of the conjunctiva (temporal and nasal regions). Individual region score was evaluated on the Ora Calibra® Corneal and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Conjunctival sum score ranges from 0 to 8. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Total score was sum of all 5 regions: central, superior, inferior, temporal, and nasal. Individual region score was evaluated on the Ora Calibra® Corneal and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 20. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It is evaluated for the inferior region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It is evaluated for the superior region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It is evaluated for the central region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It is evaluated for the temporal region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It is evaluated for the nasal region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Corneal sum score is the sum of all regions of the cornea (inferior, superior and central regions). Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 12. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Conjunctival sum score is the sum of all regions of the conjunctiva (temporal and nasal regions). Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 8. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Total score was sum of all 5 regions: central, superior, inferior, temporal, and nasal. Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 20. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Change From Baseline in Tear Film Break-Up Time | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it takes to form micelles from the time that the eye is opened was noted. |
| Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It is evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranges from 0 to 4 (0=none and 4=severe), where lower score indicates improvement |
| Change From Baseline in Schirmer's Test | Baseline (Day 1); Days 15, 29, and 57 | The Schirmer test strip will be placed in the lower temporal lid margin of each eye. Subjects will be instructed to close their eyes and After 5 minutes have elapsed, The length of moistened area of schirmer strip will be recorded (mm) for each eye. |
| Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It was assessed by the Ora Calibra® ocular discomfort scale. The score ranges from 0 to 4 (0=none and 4=severe), where lower score indicates improvement. |
| Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of overall ocular discomfort at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. |
| Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of burning at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. |
| Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of dryness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. |
| Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of grittiness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. |
| Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of stinging at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. |
| Change From Baseline in Visual Analog Scale (Burning) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Participants rated ocular symptom of burning by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort. |
| Change From Baseline in Visual Analog Scale (Itching) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Participants rated ocular symptom of itching by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort. |
| Change From Baseline in Visual Analog Scale (Foreign Body) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Participants rated ocular symptom of foreign body by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort. |
| Change From Baseline in Visual Analog Scale (Blurred Vision) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Participants rated ocular symptom of blurred vision by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort. |
| Change From Baseline in Visual Analog Scale (Dryness) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Participants rated ocular symptom of dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort. |
| Change From Baseline in Visual Analog Scale (Photophobia) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Participants rated ocular symptom of photophobia by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort. |
| Change From Baseline in Visual Analog Scale (Pain) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | Participants rated ocular symptom of pain by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort. |
| Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Baseline (Day 1); Days 8, 15, 29, and 57 | The OSDI is a simple 12-question survey that rates the severity of the participant's dry eye disease based on the symptoms. It is assessed on a scale of 0 to 100, with higher score representing greater disability. |
| Ora Calibra® Drop Comfort Scale | Upon instillation and 1 and 2 minutes post-instillation on Day 1 | Ora Calibra® drop comfort scale ranges from 0 to 10. A score of 0 indicates comfortable and 10 indicates uncomfortable. Lower score indicated better comfort level. |
| Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | From Baseline (Day 1) to Day 56 | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of overall ocular discomfort twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week. |
| Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It is evaluated for the inferior region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
| Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | From Baseline (Day 1) to Day 56 | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of dryness twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week. |
| Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | From Baseline (Day 1) to Day 56 | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of grittiness twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week. |
| Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | From Baseline (Day 1) to Day 56 | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of stinging twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week. |
| Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | From Baseline (Day 1) to Day 56 | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of burning twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week. |
| Mean Change From Baseline in Fluorescein Staining (Superior Region) | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | It is evaluated for the superior region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. |
Countries
United States
Participant flow
Recruitment details
Participants who met all the eligibility criteria were enrolled at 2 sites in the United States.
Pre-assignment details
All participants went through a placebo run-in period for 14 days prior to randomization. During the period, exposures to the controlled adverse environment® (CAE) were conducted to ascertain eligibility to enter the study. Those who qualified were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 0.10% HL036 Ophthalmic Solution Participants self-administered HL036 0.10 % ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | 50 |
| 0.25% HL036 Ophthalmic Solution Participants self-administered HL036 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | 50 |
| Placebo Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | 50 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative Reasons | 1 | 0 | 0 |
| Overall Study | Adverse Event | 3 | 5 | 0 |
| Overall Study | Hypertension Not Controlled | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | 0.10% HL036 Ophthalmic Solution | 0.25% HL036 Ophthalmic Solution | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 13.09 | 63.5 years STANDARD_DEVIATION 9.92 | 66.1 years STANDARD_DEVIATION 11.38 | 63.5 years STANDARD_DEVIATION 11.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 49 Participants | 48 Participants | 145 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 48 Participants | 48 Participants | 145 Participants |
| Sex: Female, Male Female | 30 Participants | 40 Participants | 38 Participants | 108 Participants |
| Sex: Female, Male Male | 20 Participants | 10 Participants | 12 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 13 / 50 | 13 / 50 | 9 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
Coprimary Endpoint: Change From Baseline in Inferior Corneal Staining Score to Day 57 (Pre-CAE)
It was evaluated for the inferior region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement.
Time frame: Baseline (Day 1 Pre-CAE), Day 57 (Pre-CAE)
Population: ITT Population with the Markov Chain Monte Carlo (MCMC) imputation method for missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Coprimary Endpoint: Change From Baseline in Inferior Corneal Staining Score to Day 57 (Pre-CAE) | Day 1 Pre-CAE | 1.94 score on a scale | Standard Deviation 0.512 |
| 0.10% HL036 Ophthalmic Solution | Coprimary Endpoint: Change From Baseline in Inferior Corneal Staining Score to Day 57 (Pre-CAE) | Change From Baseline to Day 57 (pre-CAE) | 0.10 score on a scale | Standard Deviation 0.699 |
| 0.25% HL036 Ophthalmic Solution | Coprimary Endpoint: Change From Baseline in Inferior Corneal Staining Score to Day 57 (Pre-CAE) | Day 1 Pre-CAE | 1.96 score on a scale | Standard Deviation 0.45 |
| 0.25% HL036 Ophthalmic Solution | Coprimary Endpoint: Change From Baseline in Inferior Corneal Staining Score to Day 57 (Pre-CAE) | Change From Baseline to Day 57 (pre-CAE) | 0.10 score on a scale | Standard Deviation 0.49 |
| Placebo | Coprimary Endpoint: Change From Baseline in Inferior Corneal Staining Score to Day 57 (Pre-CAE) | Day 1 Pre-CAE | 1.95 score on a scale | Standard Deviation 0.433 |
| Placebo | Coprimary Endpoint: Change From Baseline in Inferior Corneal Staining Score to Day 57 (Pre-CAE) | Change From Baseline to Day 57 (pre-CAE) | -0.02 score on a scale | Standard Deviation 0.631 |
p-value: 0.337895% CI: [-0.12, 0.34]ANCOVA
p-value: 0.288395% CI: [-0.1, 0.35]ANCOVA
p-value: 0.929395% CI: [-0.22, 0.24]ANCOVA
Primary
Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE)
It is assessed by the Ora Calibra® Ocular Discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe) with 1 point increments, where lower scores indicate improvement.
Time frame: Baseline (Day 1 Pre-CAE), Day 57 (Pre-CAE)
Population: ITT Population with the MCMC imputation method for missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) | Day 1 Pre-CAE | 2.6 score on a scale | Standard Deviation 0.86 |
| 0.10% HL036 Ophthalmic Solution | Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) | Change from Baseline: Day 57 (Pre-CAE) | -0.5 score on a scale | Standard Deviation 1.16 |
| 0.25% HL036 Ophthalmic Solution | Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) | Day 1 Pre-CAE | 2.5 score on a scale | Standard Deviation 0.95 |
| 0.25% HL036 Ophthalmic Solution | Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) | Change from Baseline: Day 57 (Pre-CAE) | -0.4 score on a scale | Standard Deviation 1.33 |
| Placebo | Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) | Day 1 Pre-CAE | 2.4 score on a scale | Standard Deviation 0.75 |
| Placebo | Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) | Change from Baseline: Day 57 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 0.88 |
p-value: 0.147395% CI: [-0.7, 0.1]ANCOVA
p-value: 0.232195% CI: [-0.7, 0.2]ANCOVA
p-value: 0.821795% CI: [-0.4, 0.5]ANCOVA
Secondary
Change From Baseline in Ocular Surface and Disease Index (OSDI©)
The OSDI is a simple 12-question survey that rates the severity of the participant's dry eye disease based on the symptoms. It is assessed on a scale of 0 to 100, with higher score representing greater disability.
Time frame: Baseline (Day 1); Days 8, 15, 29, and 57
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 29 | -0.92 score on a scale | Standard Deviation 10.324 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 15 | -0.49 score on a scale | Standard Deviation 9.048 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Day 1 | 32.45 score on a scale | Standard Deviation 14.379 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 8 | -1.57 score on a scale | Standard Deviation 7.885 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 57 | -1.45 score on a scale | Standard Deviation 11.598 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 15 | -2.98 score on a scale | Standard Deviation 10.361 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Day 1 | 36.78 score on a scale | Standard Deviation 18.209 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 8 | -0.87 score on a scale | Standard Deviation 7.889 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 29 | -4.42 score on a scale | Standard Deviation 12.54 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 57 | -3.33 score on a scale | Standard Deviation 11.978 |
| Placebo | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 57 | -5.05 score on a scale | Standard Deviation 10.817 |
| Placebo | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 29 | -5.48 score on a scale | Standard Deviation 12.471 |
| Placebo | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Day 1 | 38.08 score on a scale | Standard Deviation 16.602 |
| Placebo | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 15 | -3.65 score on a scale | Standard Deviation 10.727 |
| Placebo | Change From Baseline in Ocular Surface and Disease Index (OSDI©) | Change From Baseline: Day 8 | -3.79 score on a scale | Standard Deviation 8.161 |
Secondary
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of burning at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 Post-CAE | 2.5 score on a scale | Standard Deviation 1.49 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 29 (Post-CAE) | -0.1 score on a scale | Standard Deviation 1.35 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 15 (Post-CAE) | -0.1 score on a scale | Standard Deviation 1.16 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 Pre-CAE | 1.6 score on a scale | Standard Deviation 1.31 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 29 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 1.14 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.62 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 57 (Post-CAE) | -0.2 score on a scale | Standard Deviation 1.09 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.0 score on a scale | Standard Deviation 1.26 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 57 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 1.22 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 8 | -0.1 score on a scale | Standard Deviation 0.81 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.1 score on a scale | Standard Deviation 1.48 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.1 score on a scale | Standard Deviation 1.25 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 15 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 1.04 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.9 score on a scale | Standard Deviation 1.12 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 Pre-CAE | 1.4 score on a scale | Standard Deviation 1.35 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 Post-CAE | 2.3 score on a scale | Standard Deviation 1.55 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 8 | 0.0 score on a scale | Standard Deviation 0.92 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 15 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.14 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 15 (Post-CAE) | 0.0 score on a scale | Standard Deviation 1.17 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.2 score on a scale | Standard Deviation 1.4 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 29 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.18 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 29 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.97 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.4 score on a scale | Standard Deviation 1.24 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 57 (Pre-CAE) | -0.5 score on a scale | Standard Deviation 1.5 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 57 (Post-CAE) | -0.1 score on a scale | Standard Deviation 1.28 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.5 score on a scale | Standard Deviation 1.26 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 29 (Post-CAE) | -0.1 score on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 8 | 0.0 score on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 57 (Post-CAE) | -0.3 score on a scale | Standard Deviation 1.01 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.3 score on a scale | Standard Deviation 1.21 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.2 score on a scale | Standard Deviation 1.29 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 Pre-CAE | 1.2 score on a scale | Standard Deviation 1.28 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 57 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 0.93 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.1 score on a scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 15 (Post-CAE) | -0.1 score on a scale | Standard Deviation 1.05 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 Post-CAE | 2.4 score on a scale | Standard Deviation 1.66 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 29 (Pre-CAE) | 0.0 score on a scale | Standard Deviation 0.84 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 15 (Pre-CAE) | 0.0 score on a scale | Standard Deviation 0.74 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.2 score on a scale | Standard Deviation 1.3 |
Secondary
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of dryness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 15 (Pre-CAE) | -0.3 score on a scale | Standard Deviation 0.8 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 Pre-CAE | 3.1 score on a scale | Standard Deviation 0.87 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 29 (Post-CAE) | -0.3 score on a scale | Standard Deviation 1.04 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 57 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.85 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 29 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.03 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.1 score on a scale | Standard Deviation 1.08 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 15 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.71 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.0 score on a scale | Standard Deviation 0.86 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.1 score on a scale | Standard Deviation 1.31 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 57 (Pre-CAE) | -0.4 score on a scale | Standard Deviation 1.25 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 8 | -0.4 score on a scale | Standard Deviation 0.9 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 Post-CAE | 4.0 score on a scale | Standard Deviation 0.71 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 0.98 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 0.98 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 Pre-CAE | 3.1 score on a scale | Standard Deviation 1.03 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 Post-CAE | 3.9 score on a scale | Standard Deviation 0.8 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.9 score on a scale | Standard Deviation 0.76 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 8 | -0.1 score on a scale | Standard Deviation 0.7 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 15 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 0.9 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 15 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.8 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 29 (Pre-CAE) | -0.4 score on a scale | Standard Deviation 1.01 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 29 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.67 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.5 score on a scale | Standard Deviation 1.17 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 57 (Pre-CAE) | -0.3 score on a scale | Standard Deviation 1.2 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 57 (Post-CAE) | -0.1 score on a scale | Standard Deviation 0.82 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.3 score on a scale | Standard Deviation 1.04 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 29 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.79 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 8 | -0.2 score on a scale | Standard Deviation 0.77 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 57 (Post-CAE) | -0.3 score on a scale | Standard Deviation 1.09 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.1 score on a scale | Standard Deviation 1.33 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.1 score on a scale | Standard Deviation 0.99 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 Pre-CAE | 3.0 score on a scale | Standard Deviation 0.84 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 57 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.08 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.29 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 15 (Post-CAE) | -0.1 score on a scale | Standard Deviation 0.95 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 Post-CAE | 4.1 score on a scale | Standard Deviation 0.63 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 29 (Pre-CAE) | -0.3 score on a scale | Standard Deviation 0.94 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 15 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 0.76 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.1 score on a scale | Standard Deviation 1.36 |
Secondary
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of grittiness at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.7 score on a scale | Standard Deviation 1.1 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.1 score on a scale | Standard Deviation 1.18 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 57 (Pre-CAE) | -0.4 score on a scale | Standard Deviation 1.2 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 8 | -0.2 score on a scale | Standard Deviation 1.06 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.44 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 57 (Post-CAE) | -0.3 score on a scale | Standard Deviation 1.06 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 15 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 1.05 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 Post-CAE | 2.7 score on a scale | Standard Deviation 1.4 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 15 (Post-CAE) | -0.1 score on a scale | Standard Deviation 1 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.29 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 Pre-CAE | 2.1 score on a scale | Standard Deviation 1.27 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 29 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.25 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 29 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.99 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 15 (Post-CAE) | 0.2 score on a scale | Standard Deviation 1.24 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 29 (Post-CAE) | 0.1 score on a scale | Standard Deviation 1.03 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.5 score on a scale | Standard Deviation 0.96 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 Post-CAE | 2.3 score on a scale | Standard Deviation 1.63 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.3 score on a scale | Standard Deviation 1.01 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 Pre-CAE | 1.8 score on a scale | Standard Deviation 1.47 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 15 (Pre-CAE) | 0.2 score on a scale | Standard Deviation 1.06 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 57 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 1.29 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 57 (Post-CAE) | 0.2 score on a scale | Standard Deviation 1.13 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 29 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 1.18 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.03 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.3 score on a scale | Standard Deviation 1.09 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 8 | -0.1 score on a scale | Standard Deviation 0.67 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.4 score on a scale | Standard Deviation 1.14 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 Pre-CAE | 2.0 score on a scale | Standard Deviation 1.35 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 Post-CAE | 3.0 score on a scale | Standard Deviation 1.28 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.1 score on a scale | Standard Deviation 1.1 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 8 | 0.1 score on a scale | Standard Deviation 0.95 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 15 (Pre-CAE) | 0.0 score on a scale | Standard Deviation 0.68 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 15 (Post-CAE) | -0.3 score on a scale | Standard Deviation 1.07 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.3 score on a scale | Standard Deviation 1.33 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 29 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.04 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 29 (Post-CAE) | -0.1 score on a scale | Standard Deviation 0.74 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.22 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 57 (Post-CAE) | -0.6 score on a scale | Standard Deviation 1.08 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 57 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 0.94 |
Secondary
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of overall ocular discomfort at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 57 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.86 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 29 (Post-CAE) | -0.1 score on a scale | Standard Deviation 0.9 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 15 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.78 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.9 score on a scale | Standard Deviation 0.82 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 29 (Pre-CAE) | -0.3 score on a scale | Standard Deviation 1.05 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.2 score on a scale | Standard Deviation 1.13 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 Post-CAE | 3.8 score on a scale | Standard Deviation 0.57 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.3 score on a scale | Standard Deviation 1.47 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 57 (Pre-CAE) | -0.5 score on a scale | Standard Deviation 1.35 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 8 | -0.3 score on a scale | Standard Deviation 0.97 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 Pre-CAE | 2.9 score on a scale | Standard Deviation 0.88 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.3 score on a scale | Standard Deviation 1.03 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 15 (Pre-CAE) | -0.4 score on a scale | Standard Deviation 0.93 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.07 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 Pre-CAE | 2.7 score on a scale | Standard Deviation 1.09 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 Post-CAE | 3.7 score on a scale | Standard Deviation 0.81 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.0 score on a scale | Standard Deviation 1.11 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 8 | 0.0 score on a scale | Standard Deviation 0.98 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 15 (Pre-CAE) | 0.0 score on a scale | Standard Deviation 1 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 15 (Post-CAE) | 0.0 score on a scale | Standard Deviation 0.66 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 29 (Pre-CAE) | -0.3 score on a scale | Standard Deviation 1.19 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 29 (Post-CAE) | 0.0 score on a scale | Standard Deviation 0.89 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.3 score on a scale | Standard Deviation 1.23 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 57 (Pre-CAE) | -0.4 score on a scale | Standard Deviation 1.35 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 57 (Post-CAE) | 0.0 score on a scale | Standard Deviation 0.64 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.5 score on a scale | Standard Deviation 1.32 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 29 (Post-CAE) | -0.1 score on a scale | Standard Deviation 0.72 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 8 | -0.2 score on a scale | Standard Deviation 0.9 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 57 (Post-CAE) | -0.4 score on a scale | Standard Deviation 0.98 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.2 score on a scale | Standard Deviation 1.49 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.2 score on a scale | Standard Deviation 0.92 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 Pre-CAE | 2.8 score on a scale | Standard Deviation 0.78 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 57 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 15 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.95 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 Post-CAE | 4.0 score on a scale | Standard Deviation 0.74 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 29 (Pre-CAE) | -0.3 score on a scale | Standard Deviation 1.17 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from Baseline: Day 15 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 0.97 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.1 score on a scale | Standard Deviation 1.33 |
Secondary
Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of stinging at all scheduled visits on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 29 (Post-CAE) | -0.3 score on a scale | Standard Deviation 1.23 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 Pre-CAE | 1.5 score on a scale | Standard Deviation 1.33 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.16 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 8 | -0.3 score on a scale | Standard Deviation 0.92 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 57 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.35 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 57 (Post-CAE) | -0.3 score on a scale | Standard Deviation 1.12 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.83 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 Post-CAE | 2.3 score on a scale | Standard Deviation 1.42 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 15 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.04 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 15 (Post-CAE) | -0.3 score on a scale | Standard Deviation 1.12 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.34 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.8 score on a scale | Standard Deviation 1.18 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 29 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.12 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 29 (Post-CAE) | -0.4 score on a scale | Standard Deviation 1.06 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.2 score on a scale | Standard Deviation 1.24 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 15 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.08 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.1 score on a scale | Standard Deviation 1.06 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 Post-CAE | 1.9 score on a scale | Standard Deviation 1.55 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.7 score on a scale | Standard Deviation 1.05 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 57 (Pre-CAE) | -0.3 score on a scale | Standard Deviation 1.4 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 15 (Post-CAE) | 0.0 score on a scale | Standard Deviation 1 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 57 (Post-CAE) | -0.1 score on a scale | Standard Deviation 1.28 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 8 | -0.2 score on a scale | Standard Deviation 0.86 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 Pre-CAE | 1.2 score on a scale | Standard Deviation 1.35 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.3 score on a scale | Standard Deviation 1.41 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 29 (Pre-CAE) | -0.3 score on a scale | Standard Deviation 1.03 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.3 score on a scale | Standard Deviation 1.51 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 57 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 1.01 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 Pre-CAE | 1.0 score on a scale | Standard Deviation 1.08 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 Post-CAE | 2.0 score on a scale | Standard Deviation 1.67 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.0 score on a scale | Standard Deviation 1.26 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 8 | -0.1 score on a scale | Standard Deviation 0.69 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 15 (Pre-CAE) | 0.0 score on a scale | Standard Deviation 0.76 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 15 (Post-CAE) | -0.1 score on a scale | Standard Deviation 1.19 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.1 score on a scale | Standard Deviation 1.41 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 29 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 0.9 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 29 (Post-CAE) | -0.2 score on a scale | Standard Deviation 1.28 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.2 score on a scale | Standard Deviation 1.47 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 57 (Post-CAE) | -0.4 score on a scale | Standard Deviation 1.3 |
Secondary
Change From Baseline in Ora Calibra® Ocular Discomfort Scale
It was assessed by the Ora Calibra® ocular discomfort scale. The score ranges from 0 to 4 (0=none and 4=severe), where lower score indicates improvement.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 15 (Pre-CAE) | -0.5 score on a scale | Standard Deviation 0.71 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Day 1 Pre-CAE | 2.6 score on a scale | Standard Deviation 0.86 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 29 (Post-CAE) | 0.0 score on a scale | Standard Deviation 0.63 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 15 (Post-CAE) | 0.0 score on a scale | Standard Deviation 0.62 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 57 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.77 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 29 (Pre-CAE) | -0.4 score on a scale | Standard Deviation 1.03 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.5 score on a scale | Standard Deviation 0.91 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Day 1 (Change from Pre-CAE to Post-CAE) | 1.2 score on a scale | Standard Deviation 0.98 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.3 score on a scale | Standard Deviation 1.3 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 57 (Pre-CAE) | -0.5 score on a scale | Standard Deviation 1.17 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 8 | -0.5 score on a scale | Standard Deviation 0.89 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Day 1 Post-CAE | 3.8 score on a scale | Standard Deviation 0.52 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.5 score on a scale | Standard Deviation 1.18 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 57 (Pre-CAE) | -0.4 score on a scale | Standard Deviation 1.39 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Day 1 Pre-CAE | 2.5 score on a scale | Standard Deviation 0.95 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Day 1 Post-CAE | 3.7 score on a scale | Standard Deviation 0.47 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Day 1 (Change from Pre-CAE to Post-CAE) | 1.2 score on a scale | Standard Deviation 1.01 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 8 | 0.1 score on a scale | Standard Deviation 0.81 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 15 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 0.96 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 15 (Post-CAE) | 0.0 score on a scale | Standard Deviation 0.58 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.1 score on a scale | Standard Deviation 1.13 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 29 (Pre-CAE) | -0.3 score on a scale | Standard Deviation 0.92 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 29 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.63 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.0 score on a scale | Standard Deviation 1.11 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 57 (Post-CAE) | -0.1 score on a scale | Standard Deviation 0.65 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.4 score on a scale | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 57 (Post-CAE) | -0.2 score on a scale | Standard Deviation 0.76 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 29 (Post-CAE) | 0.0 score on a scale | Standard Deviation 0.88 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 8 | -0.1 score on a scale | Standard Deviation 1.01 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Day 1 Pre-CAE | 2.4 score on a scale | Standard Deviation 0.75 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.1 score on a scale | Standard Deviation 1.36 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Day 1 (Change from Pre-CAE to Post-CAE) | 1.4 score on a scale | Standard Deviation 0.81 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 57 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 0.88 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Day 1 Post-CAE | 3.8 score on a scale | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.1 score on a scale | Standard Deviation 1.05 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 15 (Post-CAE) | 0.0 score on a scale | Standard Deviation 0.55 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.1 score on a scale | Standard Deviation 1.17 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 29 (Pre-CAE) | -0.2 score on a scale | Standard Deviation 1.05 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort Scale | Change from Baseline: Day 15 (Pre-CAE) | -0.1 score on a scale | Standard Deviation 0.87 |
Secondary
Change From Baseline in Schirmer's Test
The Schirmer test strip will be placed in the lower temporal lid margin of each eye. Subjects will be instructed to close their eyes and After 5 minutes have elapsed, The length of moistened area of schirmer strip will be recorded (mm) for each eye.
Time frame: Baseline (Day 1); Days 15, 29, and 57
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Day 1 | 5.0 mm | Standard Deviation 2.6 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Change From Baseline: Day 15 | 1.7 mm | Standard Deviation 5.21 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Change From Baseline: Day 29 | 0.8 mm | Standard Deviation 5.01 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Change From Baseline: Day 57 | 3.5 mm | Standard Deviation 6.7 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Change From Baseline: Day 57 | 2.9 mm | Standard Deviation 4.74 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Day 1 | 5.2 mm | Standard Deviation 3.03 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Change From Baseline: Day 29 | 0.9 mm | Standard Deviation 4.23 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Change From Baseline: Day 15 | 4.0 mm | Standard Deviation 7.36 |
| Placebo | Change From Baseline in Schirmer's Test | Change From Baseline: Day 57 | 3.3 mm | Standard Deviation 6.84 |
| Placebo | Change From Baseline in Schirmer's Test | Change From Baseline: Day 15 | 3.4 mm | Standard Deviation 6.5 |
| Placebo | Change From Baseline in Schirmer's Test | Change From Baseline: Day 29 | 1.8 mm | Standard Deviation 4.35 |
| Placebo | Change From Baseline in Schirmer's Test | Day 1 | 5.5 mm | Standard Deviation 3.02 |
Secondary
Change From Baseline in Tear Film Break-Up Time
Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it takes to form micelles from the time that the eye is opened was noted.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 57 (Post-CAE) | 0.118 seconds | Standard Deviation 0.7072 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 29 (Post-CAE) | 0.123 seconds | Standard Deviation 0.7116 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 15 (Post-CAE) | 0.312 seconds | Standard Deviation 0.947 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Day 1 (Change from Pre-CAE to Post-CAE) | -0.027 seconds | Standard Deviation 0.4552 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 29 (Pre-CAE) | 0.218 seconds | Standard Deviation 0.7586 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.075 seconds | Standard Deviation 0.7355 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Day 1 Pre-CAE | 1.559 seconds | Standard Deviation 0.5031 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Day 1 Post-CAE | 1.533 seconds | Standard Deviation 0.5217 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 57 (Pre-CAE) | 0.139 seconds | Standard Deviation 0.5727 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 8 | 0.024 seconds | Standard Deviation 0.4943 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.021 seconds | Standard Deviation 0.6113 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.054 seconds | Standard Deviation 0.5013 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 15 (Pre-CAE) | 0.386 seconds | Standard Deviation 0.8008 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.068 seconds | Standard Deviation 0.6543 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Day 1 Pre-CAE | 1.709 seconds | Standard Deviation 0.7083 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Day 1 Post-CAE | 1.555 seconds | Standard Deviation 0.5441 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Day 1 (Change from Pre-CAE to Post-CAE) | -0.154 seconds | Standard Deviation 0.5516 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 8 | -0.037 seconds | Standard Deviation 0.7421 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 15 (Pre-CAE) | 0.127 seconds | Standard Deviation 0.7945 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 15 (Post-CAE) | 0.195 seconds | Standard Deviation 0.6835 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 29 (Pre-CAE) | -0.191 seconds | Standard Deviation 0.5936 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 29 (Post-CAE) | 0.086 seconds | Standard Deviation 0.6752 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.129 seconds | Standard Deviation 0.4258 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 57 (Pre-CAE) | -0.036 seconds | Standard Deviation 0.888 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 57 (Post-CAE) | 0.039 seconds | Standard Deviation 0.6057 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.063 seconds | Standard Deviation 0.8557 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 29 (Post-CAE) | -0.188 seconds | Standard Deviation 0.3884 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 8 | -0.036 seconds | Standard Deviation 0.4948 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 57 (Post-CAE) | 0.160 seconds | Standard Deviation 0.7206 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.119 seconds | Standard Deviation 0.5623 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Day 1 (Change from Pre-CAE to Post-CAE) | -0.001 seconds | Standard Deviation 0.367 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Day 1 Pre-CAE | 1.574 seconds | Standard Deviation 0.5394 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 57 (Pre-CAE) | 0.186 seconds | Standard Deviation 0.6696 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.054 seconds | Standard Deviation 0.6252 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 15 (Post-CAE) | 0.222 seconds | Standard Deviation 0.7884 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Day 1 Post-CAE | 1.574 seconds | Standard Deviation 0.5322 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 29 (Pre-CAE) | -0.077 seconds | Standard Deviation 0.5228 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 15 (Pre-CAE) | 0.276 seconds | Standard Deviation 0.7857 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.003 seconds | Standard Deviation 0.6473 |
Secondary
Change From Baseline in the Ora Calibra® Conjunctival Redness Scale
It is evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranges from 0 to 4 (0=none and 4=severe), where lower score indicates improvement
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 57 (Post-CAE) | -0.03 score on a scale | Standard Deviation 0.591 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 29 (Post-CAE) | -0.22 score on a scale | Standard Deviation 0.635 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 15 (Post-CAE) | -0.14 score on a scale | Standard Deviation 0.663 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 (Change from Pre-CAE to Post-CAE) | 0.33 score on a scale | Standard Deviation 0.603 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 29 (Pre-CAE) | -0.06 score on a scale | Standard Deviation 0.74 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.06 score on a scale | Standard Deviation 0.983 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 Pre-CAE | 1.70 score on a scale | Standard Deviation 0.639 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 Post-CAE | 2.03 score on a scale | Standard Deviation 0.626 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 57 (Pre-CAE) | 0.01 score on a scale | Standard Deviation 0.563 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 8 | 0.04 score on a scale | Standard Deviation 0.588 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.04 score on a scale | Standard Deviation 0.788 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 0.967 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 15 (Pre-CAE) | -0.20 score on a scale | Standard Deviation 0.606 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.19 score on a scale | Standard Deviation 0.836 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 Pre-CAE | 1.66 score on a scale | Standard Deviation 0.566 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 Post-CAE | 2.02 score on a scale | Standard Deviation 0.571 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 (Change from Pre-CAE to Post-CAE) | 0.36 score on a scale | Standard Deviation 0.655 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 8 | -0.07 score on a scale | Standard Deviation 0.473 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 15 (Pre-CAE) | -0.17 score on a scale | Standard Deviation 0.559 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 15 (Post-CAE) | -0.35 score on a scale | Standard Deviation 0.515 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 29 (Pre-CAE) | -0.03 score on a scale | Standard Deviation 0.614 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 29 (Post-CAE) | -0.31 score on a scale | Standard Deviation 0.601 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.21 score on a scale | Standard Deviation 0.907 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 57 (Pre-CAE) | 0.23 score on a scale | Standard Deviation 0.66 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 57 (Post-CAE) | -0.01 score on a scale | Standard Deviation 0.728 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.22 score on a scale | Standard Deviation 0.941 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 29 (Post-CAE) | -0.21 score on a scale | Standard Deviation 0.568 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 8 | 0.00 score on a scale | Standard Deviation 0.669 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 57 (Post-CAE) | -0.14 score on a scale | Standard Deviation 0.586 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.11 score on a scale | Standard Deviation 1.012 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 (Change from Pre-CAE to Post-CAE) | 0.32 score on a scale | Standard Deviation 0.569 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 Pre-CAE | 1.72 score on a scale | Standard Deviation 0.536 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 57 (Pre-CAE) | 0.11 score on a scale | Standard Deviation 0.565 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.03 score on a scale | Standard Deviation 0.785 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 15 (Post-CAE) | -0.20 score on a scale | Standard Deviation 0.606 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 Post-CAE | 2.04 score on a scale | Standard Deviation 0.523 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 29 (Pre-CAE) | -0.10 score on a scale | Standard Deviation 0.685 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 15 (Pre-CAE) | -0.17 score on a scale | Standard Deviation 0.568 |
| Placebo | Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.28 score on a scale | Standard Deviation 0.708 |
Secondary
Change From Baseline in Visual Analog Scale (Blurred Vision)
Participants rated ocular symptom of blurred vision by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 57 (Post-CAE) | -4.0 mm | Standard Deviation 19.15 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 29 (Post-CAE) | -5.9 mm | Standard Deviation 16.34 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 15 (Post-CAE) | -1.1 mm | Standard Deviation 14.37 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Day 1 (Change from Pre-CAE to Post-CAE) | 7.9 mm | Standard Deviation 18.33 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 29 (Pre-CAE) | -2.0 mm | Standard Deviation 14.81 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -4.7 mm | Standard Deviation 16.88 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Day 1 Pre-CAE | 18.5 mm | Standard Deviation 22.85 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Day 1 Post-CAE | 26.4 mm | Standard Deviation 28.3 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 57 (Pre-CAE) | 0.5 mm | Standard Deviation 14.9 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 8 | 2.5 mm | Standard Deviation 12.34 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -4.5 mm | Standard Deviation 17.82 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -2.5 mm | Standard Deviation 19.24 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 15 (Pre-CAE) | 3.7 mm | Standard Deviation 11.94 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -4.4 mm | Standard Deviation 23.96 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Day 1 Pre-CAE | 24.0 mm | Standard Deviation 27 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Day 1 Post-CAE | 32.2 mm | Standard Deviation 30.82 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Day 1 (Change from Pre-CAE to Post-CAE) | 8.2 mm | Standard Deviation 25.15 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 8 | -4.5 mm | Standard Deviation 23.77 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 15 (Pre-CAE) | -2.9 mm | Standard Deviation 19.4 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 15 (Post-CAE) | -7.3 mm | Standard Deviation 24.44 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 29 (Pre-CAE) | -4.0 mm | Standard Deviation 18.45 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 29 (Post-CAE) | -7.9 mm | Standard Deviation 23.39 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -5.4 mm | Standard Deviation 21.62 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 57 (Pre-CAE) | -3.0 mm | Standard Deviation 21.79 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 57 (Post-CAE) | -6.9 mm | Standard Deviation 24.83 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -3.3 mm | Standard Deviation 27.89 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 29 (Post-CAE) | -6.1 mm | Standard Deviation 17.73 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 8 | -4.2 mm | Standard Deviation 15.37 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 57 (Post-CAE) | -7.8 mm | Standard Deviation 21.29 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -7.7 mm | Standard Deviation 21.6 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Day 1 (Change from Pre-CAE to Post-CAE) | 14.2 mm | Standard Deviation 20.98 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Day 1 Pre-CAE | 26.9 mm | Standard Deviation 20.32 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 57 (Pre-CAE) | -1.2 mm | Standard Deviation 19.67 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -6.6 mm | Standard Deviation 27.55 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 15 (Post-CAE) | -8.7 mm | Standard Deviation 21.87 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Day 1 Post-CAE | 41.1 mm | Standard Deviation 28.62 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 29 (Pre-CAE) | -3.2 mm | Standard Deviation 16.29 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from Baseline: Day 15 (Pre-CAE) | -2.1 mm | Standard Deviation 15.8 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurred Vision) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -6.5 mm | Standard Deviation 27.14 |
Secondary
Change From Baseline in Visual Analog Scale (Burning)
Participants rated ocular symptom of burning by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 15 (Pre-CAE) | -3.0 mm | Standard Deviation 19.75 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Day 1 Pre-CAE | 30.4 mm | Standard Deviation 28.53 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 29 (Post-CAE) | -7.3 mm | Standard Deviation 21.43 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 15 (Post-CAE) | -1.6 mm | Standard Deviation 23.56 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 57 (Post-CAE) | -1.3 mm | Standard Deviation 20.26 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 29 (Pre-CAE) | -3.0 mm | Standard Deviation 26.13 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 1.4 mm | Standard Deviation 26.91 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Day 1 (Change from Pre-CAE to Post-CAE) | 14.2 mm | Standard Deviation 23.57 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 2.2 mm | Standard Deviation 33.08 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 57 (Pre-CAE) | -3.5 mm | Standard Deviation 27.19 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 8 | -1.9 mm | Standard Deviation 19.34 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Day 1 Post-CAE | 44.6 mm | Standard Deviation 29.99 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.2 mm | Standard Deviation 23.76 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -3.5 mm | Standard Deviation 21.46 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Day 1 Pre-CAE | 29.3 mm | Standard Deviation 26.74 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Day 1 Post-CAE | 44.1 mm | Standard Deviation 33.91 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Day 1 (Change from Pre-CAE to Post-CAE) | 14.5 mm | Standard Deviation 22.27 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 8 | -4.5 mm | Standard Deviation 25.73 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 15 (Pre-CAE) | -6.7 mm | Standard Deviation 24.08 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 15 (Post-CAE) | -10.8 mm | Standard Deviation 24.27 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 29 (Pre-CAE) | -6.6 mm | Standard Deviation 26.82 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 29 (Post-CAE) | -8.8 mm | Standard Deviation 26.93 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 2.4 mm | Standard Deviation 25.72 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 57 (Pre-CAE) | -10.0 mm | Standard Deviation 31.76 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 57 (Post-CAE) | -10.3 mm | Standard Deviation 26.98 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 2.2 mm | Standard Deviation 30.19 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 29 (Post-CAE) | -3.2 mm | Standard Deviation 16 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 8 | 0.5 mm | Standard Deviation 16.66 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 57 (Post-CAE) | -4.6 mm | Standard Deviation 21.47 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -4.0 mm | Standard Deviation 24.77 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Day 1 (Change from Pre-CAE to Post-CAE) | 17.7 mm | Standard Deviation 22.75 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Day 1 Pre-CAE | 22.4 mm | Standard Deviation 24.6 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 57 (Pre-CAE) | -1.5 mm | Standard Deviation 16.19 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -2.6 mm | Standard Deviation 17.42 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 15 (Post-CAE) | -2.2 mm | Standard Deviation 16.9 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Day 1 Post-CAE | 40.1 mm | Standard Deviation 32.15 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 29 (Pre-CAE) | -0.4 mm | Standard Deviation 15.67 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Change from Baseline: Day 15 (Pre-CAE) | 0.3 mm | Standard Deviation 11.84 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -3.0 mm | Standard Deviation 23.35 |
Secondary
Change From Baseline in Visual Analog Scale (Dryness)
Participants rated ocular symptom of dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 2.3 mm | Standard Deviation 21.34 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Day 1 Pre-CAE | 57.7 mm | Standard Deviation 20.98 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Day 1 Post-CAE | 74.2 mm | Standard Deviation 18.66 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Day 1 (Change from Pre-CAE to Post-CAE) | 16.5 mm | Standard Deviation 16.76 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 8 | -4.7 mm | Standard Deviation 16.31 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 15 (Pre-CAE) | -6.7 mm | Standard Deviation 19.32 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 15 (Post-CAE) | -1.7 mm | Standard Deviation 12.82 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 5.0 mm | Standard Deviation 21.3 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 29 (Pre-CAE) | -6.4 mm | Standard Deviation 23.4 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 29 (Post-CAE) | -5.8 mm | Standard Deviation 14.15 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 57 (Pre-CAE) | -11.7 mm | Standard Deviation 24.14 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 57 (Post-CAE) | -8.3 mm | Standard Deviation 15.28 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 3.3 mm | Standard Deviation 25.71 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 57 (Pre-CAE) | -11.3 mm | Standard Deviation 26.02 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 15 (Pre-CAE) | -7.4 mm | Standard Deviation 17.94 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 15 (Post-CAE) | -4.5 mm | Standard Deviation 16.69 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 9.0 mm | Standard Deviation 24.83 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 3.0 mm | Standard Deviation 21.22 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 57 (Post-CAE) | -3.8 mm | Standard Deviation 14.57 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 29 (Pre-CAE) | -10.3 mm | Standard Deviation 19.89 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 29 (Post-CAE) | -7.1 mm | Standard Deviation 13.36 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Day 1 Pre-CAE | 58.6 mm | Standard Deviation 24.58 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 3.5 mm | Standard Deviation 20.86 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Day 1 Post-CAE | 71.8 mm | Standard Deviation 21.47 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Day 1 (Change from Pre-CAE to Post-CAE) | 13.3 mm | Standard Deviation 17.8 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 8 | -2.1 mm | Standard Deviation 14.26 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.6 mm | Standard Deviation 23.7 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 29 (Post-CAE) | -5.1 mm | Standard Deviation 12.5 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 15 (Pre-CAE) | -4.2 mm | Standard Deviation 20.52 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 57 (Pre-CAE) | -8.4 mm | Standard Deviation 26.81 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 8 | -1.6 mm | Standard Deviation 19.15 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 15 (Post-CAE) | -1.7 mm | Standard Deviation 17.81 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Day 1 Pre-CAE | 58.0 mm | Standard Deviation 22.9 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Day 1 (Change from Pre-CAE to Post-CAE) | 17.0 mm | Standard Deviation 18.3 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 2.5 mm | Standard Deviation 22.67 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 1.7 mm | Standard Deviation 25.52 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Day 1 Post-CAE | 75.0 mm | Standard Deviation 18.09 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 29 (Pre-CAE) | -7.1 mm | Standard Deviation 25.61 |
| Placebo | Change From Baseline in Visual Analog Scale (Dryness) | Change from Baseline: Day 57 (Post-CAE) | -7.7 mm | Standard Deviation 22.21 |
Secondary
Change From Baseline in Visual Analog Scale (Foreign Body)
Participants rated ocular symptom of foreign body by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 57 (Post-CAE) | -10.3 mm | Standard Deviation 23.81 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 15 (Pre-CAE) | -7.8 mm | Standard Deviation 23 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 57 (Pre-CAE) | -9.3 mm | Standard Deviation 21.64 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Day 1 Post-CAE | 45.1 mm | Standard Deviation 29.54 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 15 (Post-CAE) | -8.5 mm | Standard Deviation 20.45 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 1.4 mm | Standard Deviation 19.18 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -1.0 mm | Standard Deviation 27.77 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.6 mm | Standard Deviation 28.16 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 8 | -6.2 mm | Standard Deviation 23.33 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Day 1 Pre-CAE | 35.3 mm | Standard Deviation 25.95 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Day 1 (Change from Pre-CAE to Post-CAE) | 9.8 mm | Standard Deviation 24.25 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 29 (Post-CAE) | -8.6 mm | Standard Deviation 16.41 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 29 (Pre-CAE) | -6.2 mm | Standard Deviation 28.69 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 29 (Post-CAE) | -4.7 mm | Standard Deviation 19.58 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 2.6 mm | Standard Deviation 19.77 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Day 1 Pre-CAE | 35.1 mm | Standard Deviation 29.19 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 57 (Pre-CAE) | -7.3 mm | Standard Deviation 28.49 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 57 (Post-CAE) | -1.5 mm | Standard Deviation 27.06 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 8 | -3.4 mm | Standard Deviation 16.32 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 6.9 mm | Standard Deviation 30.44 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 29 (Pre-CAE) | -5.0 mm | Standard Deviation 16.97 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 15 (Pre-CAE) | -1.3 mm | Standard Deviation 18.83 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 15 (Post-CAE) | -0.7 mm | Standard Deviation 21.9 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Day 1 Post-CAE | 43.1 mm | Standard Deviation 31.03 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.8 mm | Standard Deviation 27.76 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body) | Day 1 (Change from Pre-CAE to Post-CAE) | 8.1 mm | Standard Deviation 22.3 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -3.7 mm | Standard Deviation 25.32 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Day 1 Pre-CAE | 34.1 mm | Standard Deviation 25.87 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Day 1 Post-CAE | 49.9 mm | Standard Deviation 27.82 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Day 1 (Change from Pre-CAE to Post-CAE) | 15.8 mm | Standard Deviation 21.57 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 8 | -0.4 mm | Standard Deviation 19.69 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 15 (Pre-CAE) | -5.0 mm | Standard Deviation 17.15 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 15 (Post-CAE) | -7.9 mm | Standard Deviation 18.96 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -2.8 mm | Standard Deviation 20.72 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 29 (Pre-CAE) | -5.9 mm | Standard Deviation 26.37 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 29 (Post-CAE) | -1.1 mm | Standard Deviation 20.54 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.6 mm | Standard Deviation 22.53 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 57 (Pre-CAE) | -5.2 mm | Standard Deviation 18.58 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body) | Change from Baseline: Day 57 (Post-CAE) | -8.5 mm | Standard Deviation 19.2 |
Secondary
Change From Baseline in Visual Analog Scale (Itching)
Participants rated ocular symptom of itching by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Day 1 Pre-CAE | 28.6 mm | Standard Deviation 27.09 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 29 (Post-CAE) | -9.3 mm | Standard Deviation 19.47 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 15 (Post-CAE) | -8.0 mm | Standard Deviation 22.37 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 57 (Post-CAE) | -7.0 mm | Standard Deviation 27.35 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 29 (Pre-CAE) | -2.7 mm | Standard Deviation 24.78 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -4.9 mm | Standard Deviation 27.23 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 8 | -6.0 mm | Standard Deviation 19.05 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Day 1 (Change from Pre-CAE to Post-CAE) | 8.4 mm | Standard Deviation 21.67 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.2 mm | Standard Deviation 25.65 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 57 (Pre-CAE) | -6.8 mm | Standard Deviation 22.73 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Day 1 Post-CAE | 37.0 mm | Standard Deviation 30.45 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -3.6 mm | Standard Deviation 15.78 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 15 (Pre-CAE) | -3.1 mm | Standard Deviation 19.18 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 2.2 mm | Standard Deviation 21.18 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Day 1 Pre-CAE | 26.2 mm | Standard Deviation 29.26 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Day 1 Post-CAE | 31.9 mm | Standard Deviation 33.26 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Day 1 (Change from Pre-CAE to Post-CAE) | 5.2 mm | Standard Deviation 18 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 8 | -2.8 mm | Standard Deviation 22.23 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 15 (Pre-CAE) | -4.5 mm | Standard Deviation 18.28 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 15 (Post-CAE) | -2.4 mm | Standard Deviation 19.21 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 29 (Pre-CAE) | -9.5 mm | Standard Deviation 20.74 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 29 (Post-CAE) | -6.2 mm | Standard Deviation 23.64 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 5.2 mm | Standard Deviation 26.67 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 57 (Pre-CAE) | -8.1 mm | Standard Deviation 27.02 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 57 (Post-CAE) | -5.7 mm | Standard Deviation 23.95 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 4.7 mm | Standard Deviation 22.75 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 29 (Post-CAE) | 2.2 mm | Standard Deviation 23.3 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 8 | 0.5 mm | Standard Deviation 19.54 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 57 (Post-CAE) | -2.1 mm | Standard Deviation 19.13 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 3.6 mm | Standard Deviation 25.99 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Day 1 (Change from Pre-CAE to Post-CAE) | 8.2 mm | Standard Deviation 22.76 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Day 1 Pre-CAE | 26.8 mm | Standard Deviation 23.7 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 57 (Pre-CAE) | -1.2 mm | Standard Deviation 23.65 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.3 mm | Standard Deviation 19.52 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 15 (Post-CAE) | 1.9 mm | Standard Deviation 16.56 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Day 1 Post-CAE | 35.0 mm | Standard Deviation 28.92 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 29 (Pre-CAE) | -1.7 mm | Standard Deviation 20.97 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 15 (Pre-CAE) | 1.6 mm | Standard Deviation 20.27 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.2 mm | Standard Deviation 26.94 |
Secondary
Change From Baseline in Visual Analog Scale (Pain)
Participants rated ocular symptom of pain by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 57 (Post-CAE) | -10.9 mm | Standard Deviation 16.16 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 29 (Post-CAE) | -8.0 mm | Standard Deviation 16.05 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 15 (Post-CAE) | -3.9 mm | Standard Deviation 17.59 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Day 1 (Change from Pre-CAE to Post-CAE) | 12.1 mm | Standard Deviation 19.65 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 29 (Pre-CAE) | -3.8 mm | Standard Deviation 17.3 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -5.7 mm | Standard Deviation 19.81 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Day 1 Pre-CAE | 17.0 mm | Standard Deviation 22.31 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Day 1 Post-CAE | 29.1 mm | Standard Deviation 30.5 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 57 (Pre-CAE) | -0.2 mm | Standard Deviation 22.85 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 8 | -2.2 mm | Standard Deviation 11.94 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -10.7 mm | Standard Deviation 28.15 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -3.3 mm | Standard Deviation 15.38 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 15 (Pre-CAE) | 1.8 mm | Standard Deviation 20.34 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 1.5 mm | Standard Deviation 22.96 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Day 1 Pre-CAE | 17.8 mm | Standard Deviation 23.62 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Day 1 Post-CAE | 26.3 mm | Standard Deviation 29.53 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Day 1 (Change from Pre-CAE to Post-CAE) | 8.3 mm | Standard Deviation 15.81 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 8 | -1.8 mm | Standard Deviation 22.41 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 15 (Pre-CAE) | -3.1 mm | Standard Deviation 22.9 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 15 (Post-CAE) | -2.0 mm | Standard Deviation 16.84 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 29 (Pre-CAE) | -3.3 mm | Standard Deviation 20.23 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 29 (Post-CAE) | -1.8 mm | Standard Deviation 18.57 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 7.7 mm | Standard Deviation 16.05 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 57 (Pre-CAE) | -6.6 mm | Standard Deviation 24.8 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 57 (Post-CAE) | -4.1 mm | Standard Deviation 20.22 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 3.9 mm | Standard Deviation 21.67 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 29 (Post-CAE) | -9.9 mm | Standard Deviation 18.61 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 8 | -2.6 mm | Standard Deviation 13.91 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 57 (Post-CAE) | -2.1 mm | Standard Deviation 12.68 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -8.1 mm | Standard Deviation 20.05 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Day 1 (Change from Pre-CAE to Post-CAE) | 9.7 mm | Standard Deviation 20.73 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Day 1 Pre-CAE | 17.4 mm | Standard Deviation 21.01 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 57 (Pre-CAE) | -2.8 mm | Standard Deviation 14.32 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.8 mm | Standard Deviation 23.07 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 15 (Post-CAE) | -2.8 mm | Standard Deviation 18.66 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Day 1 Post-CAE | 27.1 mm | Standard Deviation 29.83 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 29 (Pre-CAE) | -3.4 mm | Standard Deviation 15.35 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 15 (Pre-CAE) | -2.1 mm | Standard Deviation 14.54 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.7 mm | Standard Deviation 16.52 |
Secondary
Change From Baseline in Visual Analog Scale (Photophobia)
Participants rated ocular symptom of photophobia by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to no discomfort and 100 mm corresponds to maximal discomfort.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 29 (Pre-CAE) | -3.1 mm | Standard Deviation 19.61 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 Pre-CAE | 32.8 mm | Standard Deviation 28.41 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 Post-CAE | 38.1 mm | Standard Deviation 29.8 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 (Change from Pre-CAE to Post-CAE) | 5.3 mm | Standard Deviation 16.7 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 8 | 1.4 mm | Standard Deviation 16.17 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 15 (Pre-CAE) | -1.4 mm | Standard Deviation 16.19 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 15 (Post-CAE) | -2.4 mm | Standard Deviation 14.21 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -1.0 mm | Standard Deviation 19.59 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 29 (Post-CAE) | -4.0 mm | Standard Deviation 13.84 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 3.0 mm | Standard Deviation 17.38 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 57 (Pre-CAE) | -4.1 mm | Standard Deviation 20.87 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 57 (Post-CAE) | -4.0 mm | Standard Deviation 21.66 |
| 0.10% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.2 mm | Standard Deviation 28.34 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 1.5 mm | Standard Deviation 21.4 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 5.8 mm | Standard Deviation 23.32 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 Pre-CAE | 37.4 mm | Standard Deviation 33.86 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 15 (Post-CAE) | -5.7 mm | Standard Deviation 19.94 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 2.1 mm | Standard Deviation 13.89 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 Post-CAE | 39.8 mm | Standard Deviation 34.5 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 29 (Pre-CAE) | -7.3 mm | Standard Deviation 28.18 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 15 (Pre-CAE) | -11.0 mm | Standard Deviation 22.36 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 (Change from Pre-CAE to Post-CAE) | 2.2 mm | Standard Deviation 21.2 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 57 (Post-CAE) | -2.3 mm | Standard Deviation 20.85 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 29 (Post-CAE) | -4.9 mm | Standard Deviation 18.11 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 8 | -5.0 mm | Standard Deviation 21.4 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 57 (Pre-CAE) | -3.6 mm | Standard Deviation 26.95 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 8 | -2.7 mm | Standard Deviation 18.46 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 15 (Pre-CAE) | -2.1 mm | Standard Deviation 18.17 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 57 (Pre-CAE) | -3.6 mm | Standard Deviation 22.33 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 15 (Post-CAE) | -8.8 mm | Standard Deviation 18.47 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -6.7 mm | Standard Deviation 22.12 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 29 (Pre-CAE) | -3.1 mm | Standard Deviation 26.01 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 29 (Post-CAE) | -0.9 mm | Standard Deviation 18.18 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 57 (Post-CAE) | -10.4 mm | Standard Deviation 23.91 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 Pre-CAE | 36.7 mm | Standard Deviation 29.19 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 Post-CAE | 49.7 mm | Standard Deviation 32.33 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -2.7 mm | Standard Deviation 27.46 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 (Change from Pre-CAE to Post-CAE) | 13.0 mm | Standard Deviation 22.01 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -6.5 mm | Standard Deviation 24.53 |
Secondary
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning)
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of burning twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week.
Time frame: From Baseline (Day 1) to Day 56
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.22 score on a scale | Standard Deviation 0.43 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.27 score on a scale | Standard Deviation 0.571 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.18 score on a scale | Standard Deviation 0.506 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.26 score on a scale | Standard Deviation 0.449 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Baseline: Daily average | 1.72 score on a scale | Standard Deviation 1.126 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.25 score on a scale | Standard Deviation 0.565 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.26 score on a scale | Standard Deviation 0.369 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.13 score on a scale | Standard Deviation 0.309 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.25 score on a scale | Standard Deviation 0.44 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.29 score on a scale | Standard Deviation 0.511 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Baseline: Daily average | 1.49 score on a scale | Standard Deviation 1.134 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.08 score on a scale | Standard Deviation 0.398 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.17 score on a scale | Standard Deviation 0.438 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.21 score on a scale | Standard Deviation 0.498 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.28 score on a scale | Standard Deviation 0.523 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.35 score on a scale | Standard Deviation 0.701 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.33 score on a scale | Standard Deviation 0.647 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.33 score on a scale | Standard Deviation 0.739 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.11 score on a scale | Standard Deviation 0.42 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Baseline: Daily average | 1.50 score on a scale | Standard Deviation 1.135 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.17 score on a scale | Standard Deviation 0.5 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.07 score on a scale | Standard Deviation 0.328 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.11 score on a scale | Standard Deviation 0.527 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.18 score on a scale | Standard Deviation 0.546 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.12 score on a scale | Standard Deviation 0.464 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.13 score on a scale | Standard Deviation 0.564 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.11 score on a scale | Standard Deviation 0.511 |
Secondary
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness)
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of dryness twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week.
Time frame: From Baseline (Day 1) to Day 56
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.20 score on a scale | Standard Deviation 0.615 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.40 score on a scale | Standard Deviation 0.793 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.17 score on a scale | Standard Deviation 0.691 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.23 score on a scale | Standard Deviation 0.62 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Baseline: Daily average | 2.88 score on a scale | Standard Deviation 0.793 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.35 score on a scale | Standard Deviation 0.728 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.20 score on a scale | Standard Deviation 0.505 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.13 score on a scale | Standard Deviation 0.391 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.30 score on a scale | Standard Deviation 0.68 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.30 score on a scale | Standard Deviation 0.519 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Baseline: Daily average | 2.96 score on a scale | Standard Deviation 0.968 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.11 score on a scale | Standard Deviation 0.275 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.14 score on a scale | Standard Deviation 0.388 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.25 score on a scale | Standard Deviation 0.479 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.29 score on a scale | Standard Deviation 0.485 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.32 score on a scale | Standard Deviation 0.628 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.31 score on a scale | Standard Deviation 0.704 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.29 score on a scale | Standard Deviation 0.703 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.13 score on a scale | Standard Deviation 0.504 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Baseline: Daily average | 2.99 score on a scale | Standard Deviation 0.669 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.23 score on a scale | Standard Deviation 0.677 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.10 score on a scale | Standard Deviation 0.383 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.27 score on a scale | Standard Deviation 0.812 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.29 score on a scale | Standard Deviation 0.659 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.13 score on a scale | Standard Deviation 0.621 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.25 score on a scale | Standard Deviation 0.768 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.21 score on a scale | Standard Deviation 0.69 |
Secondary
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness)
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of grittiness twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week.
Time frame: From Baseline (Day 1) to Day 56
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.22 score on a scale | Standard Deviation 0.594 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.36 score on a scale | Standard Deviation 0.764 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.21 score on a scale | Standard Deviation 0.724 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.26 score on a scale | Standard Deviation 0.628 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Baseline: Daily average | 2.14 score on a scale | Standard Deviation 0.988 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.38 score on a scale | Standard Deviation 0.682 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.27 score on a scale | Standard Deviation 0.555 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.19 score on a scale | Standard Deviation 0.45 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.35 score on a scale | Standard Deviation 0.682 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.21 score on a scale | Standard Deviation 0.615 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Baseline: Daily average | 1.84 score on a scale | Standard Deviation 1.248 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.07 score on a scale | Standard Deviation 0.331 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.07 score on a scale | Standard Deviation 0.5 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.16 score on a scale | Standard Deviation 0.54 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.22 score on a scale | Standard Deviation 0.554 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.18 score on a scale | Standard Deviation 0.642 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.16 score on a scale | Standard Deviation 0.833 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.11 score on a scale | Standard Deviation 0.959 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.08 score on a scale | Standard Deviation 0.555 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Baseline: Daily average | 2.07 score on a scale | Standard Deviation 1.177 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.18 score on a scale | Standard Deviation 0.561 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.03 score on a scale | Standard Deviation 0.407 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.18 score on a scale | Standard Deviation 0.708 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.23 score on a scale | Standard Deviation 0.655 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.14 score on a scale | Standard Deviation 0.554 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.16 score on a scale | Standard Deviation 0.666 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.18 score on a scale | Standard Deviation 0.627 |
Secondary
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort)
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of overall ocular discomfort twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week.
Time frame: From Baseline (Day 1) to Day 56
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.18 score on a scale | Standard Deviation 0.6 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.24 score on a scale | Standard Deviation 0.43 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Baseline: Daily average | 2.74 score on a scale | Standard Deviation 0.884 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.23 score on a scale | Standard Deviation 0.558 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.21 score on a scale | Standard Deviation 0.534 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.38 score on a scale | Standard Deviation 0.713 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.28 score on a scale | Standard Deviation 0.597 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.13 score on a scale | Standard Deviation 0.326 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.34 score on a scale | Standard Deviation 0.636 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.31 score on a scale | Standard Deviation 0.666 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.29 score on a scale | Standard Deviation 0.658 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Baseline: Daily average | 2.82 score on a scale | Standard Deviation 0.934 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.09 score on a scale | Standard Deviation 0.337 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.10 score on a scale | Standard Deviation 0.442 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.19 score on a scale | Standard Deviation 0.465 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.29 score on a scale | Standard Deviation 0.464 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.25 score on a scale | Standard Deviation 0.548 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.28 score on a scale | Standard Deviation 0.638 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.24 score on a scale | Standard Deviation 0.65 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.07 score on a scale | Standard Deviation 0.376 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.16 score on a scale | Standard Deviation 0.674 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.15 score on a scale | Standard Deviation 0.623 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Baseline: Daily average | 2.66 score on a scale | Standard Deviation 0.789 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.16 score on a scale | Standard Deviation 0.662 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.13 score on a scale | Standard Deviation 0.628 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.09 score on a scale | Standard Deviation 0.51 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.18 score on a scale | Standard Deviation 0.638 |
Secondary
Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging)
Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of stinging twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week.
Time frame: From Baseline (Day 1) to Day 56
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.16 score on a scale | Standard Deviation 0.428 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.22 score on a scale | Standard Deviation 0.575 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.11 score on a scale | Standard Deviation 0.572 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.12 score on a scale | Standard Deviation 0.517 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Baseline: Daily average | 1.53 score on a scale | Standard Deviation 1.113 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.24 score on a scale | Standard Deviation 0.553 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.24 score on a scale | Standard Deviation 0.409 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.14 score on a scale | Standard Deviation 0.349 |
| 0.10% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.22 score on a scale | Standard Deviation 0.564 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.28 score on a scale | Standard Deviation 0.533 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Baseline: Daily average | 1.20 score on a scale | Standard Deviation 1.127 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.13 score on a scale | Standard Deviation 0.327 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.12 score on a scale | Standard Deviation 0.438 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.22 score on a scale | Standard Deviation 0.515 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.28 score on a scale | Standard Deviation 0.538 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.32 score on a scale | Standard Deviation 0.631 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.27 score on a scale | Standard Deviation 0.647 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.28 score on a scale | Standard Deviation 0.744 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 8 to Day 14: Change from Baseline Daily Average | -0.14 score on a scale | Standard Deviation 0.469 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Baseline: Daily average | 1.26 score on a scale | Standard Deviation 1.075 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 36 to Day 42: Change from Baseline Daily Average | -0.20 score on a scale | Standard Deviation 0.514 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 1 to Day 7: Change from Baseline Daily Average | -0.11 score on a scale | Standard Deviation 0.342 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 50 to Day 56: Change from Baseline Daily Average | -0.15 score on a scale | Standard Deviation 0.577 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 22 to Day 28: Change from Baseline Daily Average | -0.24 score on a scale | Standard Deviation 0.546 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 15 to Day 21: Change from Baseline Daily Average | -0.20 score on a scale | Standard Deviation 0.455 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 43 to Day 49: Change from Baseline Daily Average | -0.16 score on a scale | Standard Deviation 0.612 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Average Day 29 to Day 35: Change from Baseline Daily Average | -0.21 score on a scale | Standard Deviation 0.517 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Central Region)
It is evaluated for the central region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 57 (Post-CAE) | -0.36 score on a scale | Standard Deviation 0.765 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 29 (Post-CAE) | -0.50 score on a scale | Standard Deviation 0.612 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 15 (Post-CAE) | -0.52 score on a scale | Standard Deviation 0.749 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.77 score on a scale | Standard Deviation 0.641 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 29 (Pre-CAE) | 0.01 score on a scale | Standard Deviation 0.906 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.52 score on a scale | Standard Deviation 0.963 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 Pre-CAE | 1.45 score on a scale | Standard Deviation 0.687 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 Post-CAE | 2.22 score on a scale | Standard Deviation 0.624 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 57 (Pre-CAE) | 0.00 score on a scale | Standard Deviation 0.837 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 8 | 0.12 score on a scale | Standard Deviation 0.766 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.36 score on a scale | Standard Deviation 1.089 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.69 score on a scale | Standard Deviation 0.87 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 15 (Pre-CAE) | 0.00 score on a scale | Standard Deviation 0.869 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.34 score on a scale | Standard Deviation 0.923 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 Pre-CAE | 1.57 score on a scale | Standard Deviation 0.67 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 Post-CAE | 2.09 score on a scale | Standard Deviation 0.55 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.052 score on a scale | Standard Deviation 0.735 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 8 | -0.02 score on a scale | Standard Deviation 0.887 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.24 score on a scale | Standard Deviation 0.831 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 15 (Post-CAE) | -0.58 score on a scale | Standard Deviation 0.732 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.21 score on a scale | Standard Deviation 0.771 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 29 (Post-CAE) | -0.54 score on a scale | Standard Deviation 0.528 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.54 score on a scale | Standard Deviation 0.948 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.10 score on a scale | Standard Deviation 0.832 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 57 (Post-CAE) | -0.35 score on a scale | Standard Deviation 0.856 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.23 score on a scale | Standard Deviation 1.043 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 29 (Post-CAE) | -0.16 score on a scale | Standard Deviation 0.653 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 8 | -0.05 score on a scale | Standard Deviation 0.779 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 57 (Post-CAE) | -0.30 score on a scale | Standard Deviation 0.847 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.20 score on a scale | Standard Deviation 0.916 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.55 score on a scale | Standard Deviation 0.633 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 Pre-CAE | 1.49 score on a scale | Standard Deviation 0.61 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.20 score on a scale | Standard Deviation 0.802 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.33 score on a scale | Standard Deviation 0.956 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 15 (Post-CAE) | -0.42 score on a scale | Standard Deviation 0.724 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 Post-CAE | 2.04 score on a scale | Standard Deviation 0.676 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.07 score on a scale | Standard Deviation 0.776 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.09 score on a scale | Standard Deviation 0.78 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.13 score on a scale | Standard Deviation 0.846 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum)
Conjunctival sum score is the sum of all regions of the conjunctiva (temporal and nasal regions). Individual region score was evaluated on the Ora Calibra® Corneal and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Conjunctival sum score ranges from 0 to 8. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.60 score on a scale | Standard Deviation 1.177 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.52 score on a scale | Standard Deviation 0.986 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Post-CAE) | -0.93 score on a scale | Standard Deviation 1.212 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.93 score on a scale | Standard Deviation 0.827 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.39 score on a scale | Standard Deviation 1.263 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.31 score on a scale | Standard Deviation 1.269 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 Pre-CAE | 4.41 score on a scale | Standard Deviation 0.879 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 Post-CAE | 5.34 score on a scale | Standard Deviation 1.118 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.08 score on a scale | Standard Deviation 1.178 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 8 | -0.07 score on a scale | Standard Deviation 0.845 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.52 score on a scale | Standard Deviation 1.273 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.29 score on a scale | Standard Deviation 1.379 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.62 score on a scale | Standard Deviation 1.167 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.46 score on a scale | Standard Deviation 1.258 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 Pre-CAE | 4.38 score on a scale | Standard Deviation 0.923 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 Post-CAE | 5.09 score on a scale | Standard Deviation 0.941 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.71 score on a scale | Standard Deviation 0.964 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 8 | -0.15 score on a scale | Standard Deviation 0.875 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.60 score on a scale | Standard Deviation 1.158 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Post-CAE) | -1.06 score on a scale | Standard Deviation 1.295 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.35 score on a scale | Standard Deviation 1.36 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.58 score on a scale | Standard Deviation 1.206 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.38 score on a scale | Standard Deviation 1.219 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Pre-CAE) | 0.07 score on a scale | Standard Deviation 1.269 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.50 score on a scale | Standard Deviation 1.528 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.55 score on a scale | Standard Deviation 1.573 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.39 score on a scale | Standard Deviation 0.927 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 8 | -0.18 score on a scale | Standard Deviation 1.349 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.70 score on a scale | Standard Deviation 1.194 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.37 score on a scale | Standard Deviation 1.377 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.99 score on a scale | Standard Deviation 1.095 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 Pre-CAE | 4.16 score on a scale | Standard Deviation 1.052 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.33 score on a scale | Standard Deviation 1.223 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.85 score on a scale | Standard Deviation 1.44 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Post-CAE) | -1.05 score on a scale | Standard Deviation 1.135 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 Post-CAE | 5.15 score on a scale | Standard Deviation 0.981 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.14 score on a scale | Standard Deviation 1.327 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.20 score on a scale | Standard Deviation 1.143 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.41 score on a scale | Standard Deviation 1.306 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Corneal Sum)
Corneal sum score is the sum of all regions of the cornea (inferior, superior and central regions). Individual region score was evaluated on the Ora Calibra® Corneal and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Corneal sum score ranges from 0 to 12. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 57 (Post-CAE) | -1.28 score on a scale | Standard Deviation 1.618 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 29 (Post-CAE) | -1.41 score on a scale | Standard Deviation 1.389 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 15 (Post-CAE) | -1.80 score on a scale | Standard Deviation 2.058 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 2.79 score on a scale | Standard Deviation 1.258 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.22 score on a scale | Standard Deviation 1.995 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -1.46 score on a scale | Standard Deviation 1.935 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 Pre-CAE | 5.44 score on a scale | Standard Deviation 1.232 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 Post-CAE | 8.23 score on a scale | Standard Deviation 1.318 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 57 (Pre-CAE) | 0.03 score on a scale | Standard Deviation 1.47 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 8 | 0.22 score on a scale | Standard Deviation 1.559 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -1.32 score on a scale | Standard Deviation 2.034 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -1.76 score on a scale | Standard Deviation 1.85 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.34 score on a scale | Standard Deviation 1.939 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -1.27 score on a scale | Standard Deviation 1.516 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 Pre-CAE | 5.61 score on a scale | Standard Deviation 1.23 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 Post-CAE | 7.90 score on a scale | Standard Deviation 1.241 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 2.29 score on a scale | Standard Deviation 1.246 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 8 | -0.30 score on a scale | Standard Deviation 1.584 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.89 score on a scale | Standard Deviation 1.562 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 15 (Post-CAE) | -2.16 score on a scale | Standard Deviation 1.695 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.42 score on a scale | Standard Deviation 1.404 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 29 (Post-CAE) | -2.02 score on a scale | Standard Deviation 1.36 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -2.08 score on a scale | Standard Deviation 1.659 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.14 score on a scale | Standard Deviation 1.579 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 57 (Post-CAE) | -1.56 score on a scale | Standard Deviation 1.78 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -1.36 score on a scale | Standard Deviation 1.881 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.71 score on a scale | Standard Deviation 1.205 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 8 | -0.10 score on a scale | Standard Deviation 1.544 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 57 (Post-CAE) | -1.16 score on a scale | Standard Deviation 1.748 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.93 score on a scale | Standard Deviation 1.438 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 2.22 score on a scale | Standard Deviation 1.135 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 Pre-CAE | 5.47 score on a scale | Standard Deviation 1.154 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.41 score on a scale | Standard Deviation 1.634 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.97 score on a scale | Standard Deviation 1.739 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 15 (Post-CAE) | -1.45 score on a scale | Standard Deviation 1.526 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 Post-CAE | 7.69 score on a scale | Standard Deviation 1.34 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.17 score on a scale | Standard Deviation 1.704 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.48 score on a scale | Standard Deviation 1.474 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.84 score on a scale | Standard Deviation 1.801 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
It is evaluated for the inferior region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 Pre-CAE | 1.94 score on a scale | Standard Deviation 0.512 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 Post-CAE | 3.32 score on a scale | Standard Deviation 0.492 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.38 score on a scale | Standard Deviation 0.521 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 8 | 0.19 score on a scale | Standard Deviation 0.706 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.12 score on a scale | Standard Deviation 0.697 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.62 score on a scale | Standard Deviation 0.766 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.50 score on a scale | Standard Deviation 0.892 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 29 (Pre-CAE) | 0.04 score on a scale | Standard Deviation 0.807 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.66 score on a scale | Standard Deviation 0.857 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 57 (Pre-CAE) | 0.12 score on a scale | Standard Deviation 0.724 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.47 score on a scale | Standard Deviation 0.67 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.59 score on a scale | Standard Deviation 0.878 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.41 score on a scale | Standard Deviation 0.656 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.20 score on a scale | Standard Deviation 0.608 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.85 score on a scale | Standard Deviation 0.736 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.84 score on a scale | Standard Deviation 0.738 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.66 score on a scale | Standard Deviation 0.793 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 29 (Pre-CAE) | 0.04 score on a scale | Standard Deviation 0.563 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.83 score on a scale | Standard Deviation 0.677 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 Pre-CAE | 1.96 score on a scale | Standard Deviation 0.45 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -1.02 score on a scale | Standard Deviation 0.624 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 Post-CAE | 3.25 score on a scale | Standard Deviation 0.565 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.92 score on a scale | Standard Deviation 0.663 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.29 score on a scale | Standard Deviation 0.464 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 57 (Pre-CAE) | 0.10 score on a scale | Standard Deviation 0.512 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 8 | -0.01 score on a scale | Standard Deviation 0.606 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.25 score on a scale | Standard Deviation 0.407 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.62 score on a scale | Standard Deviation 0.747 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 Pre-CAE | 1.95 score on a scale | Standard Deviation 0.443 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.69 score on a scale | Standard Deviation 0.826 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.64 score on a scale | Standard Deviation 0.591 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.02 score on a scale | Standard Deviation 0.631 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.59 score on a scale | Standard Deviation 0.867 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.63 score on a scale | Standard Deviation 0.61 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 Post-CAE | 3.20 score on a scale | Standard Deviation 0.474 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 29 (Pre-CAE) | 0.00 score on a scale | Standard Deviation 0.707 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.10 score on a scale | Standard Deviation 0.571 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.48 score on a scale | Standard Deviation 0.569 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 8 | 0.04 score on a scale | Standard Deviation 0.668 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
It is evaluated for the nasal region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 Pre-CAE | 2.27 score on a scale | Standard Deviation 0.507 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.03 score on a scale | Standard Deviation 0.755 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.16 score on a scale | Standard Deviation 0.83 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.28 score on a scale | Standard Deviation 0.696 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.01 score on a scale | Standard Deviation 0.771 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.44 score on a scale | Standard Deviation 0.697 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.29 score on a scale | Standard Deviation 0.671 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.47 score on a scale | Standard Deviation 0.557 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.20 score on a scale | Standard Deviation 0.735 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.28 score on a scale | Standard Deviation 0.743 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 Post-CAE | 2.74 score on a scale | Standard Deviation 0.649 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.17 score on a scale | Standard Deviation 0.658 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 8 | -0.06 score on a scale | Standard Deviation 0.501 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.29 score on a scale | Standard Deviation 0.6 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.52 score on a scale | Standard Deviation 0.785 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.23 score on a scale | Standard Deviation 0.772 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.18 score on a scale | Standard Deviation 0.688 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.19 score on a scale | Standard Deviation 0.694 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.06 score on a scale | Standard Deviation 0.589 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 57 (Pre-CAE) | 0.01 score on a scale | Standard Deviation 0.678 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.26 score on a scale | Standard Deviation 0.96 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.27 score on a scale | Standard Deviation 0.928 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 Pre-CAE | 2.26 score on a scale | Standard Deviation 0.527 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 Post-CAE | 2.67 score on a scale | Standard Deviation 0.577 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.41 score on a scale | Standard Deviation 0.541 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 8 | -0.05 score on a scale | Standard Deviation 0.518 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.20 score on a scale | Standard Deviation 0.643 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.51 score on a scale | Standard Deviation 0.773 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 Pre-CAE | 2.14 score on a scale | Standard Deviation 0.544 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.04 score on a scale | Standard Deviation 0.783 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.06 score on a scale | Standard Deviation 0.62 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 Post-CAE | 2.68 score on a scale | Standard Deviation 0.587 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.45 score on a scale | Standard Deviation 0.859 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.24 score on a scale | Standard Deviation 0.6 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 8 | -0.05 score on a scale | Standard Deviation 0.702 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.38 score on a scale | Standard Deviation 0.718 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.17 score on a scale | Standard Deviation 0.877 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.54 score on a scale | Standard Deviation 0.638 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.15 score on a scale | Standard Deviation 0.805 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Superior Region)
It is evaluated for the superior region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 Pre-CAE | 2.05 score on a scale | Standard Deviation 0.42 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 Post-CAE | 2.69 score on a scale | Standard Deviation 0.552 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.64 score on a scale | Standard Deviation 0.598 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 8 | -0.09 score on a scale | Standard Deviation 0.586 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.66 score on a scale | Standard Deviation 0.976 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.44 score on a scale | Standard Deviation 0.884 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.27 score on a scale | Standard Deviation 0.709 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.50 score on a scale | Standard Deviation 0.655 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.41 score on a scale | Standard Deviation 0.791 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.09 score on a scale | Standard Deviation 0.571 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.46 score on a scale | Standard Deviation 0.665 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.37 score on a scale | Standard Deviation 0.806 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.22 score on a scale | Standard Deviation 0.79 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.14 score on a scale | Standard Deviation 0.594 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 Pre-CAE | 2.08 score on a scale | Standard Deviation 0.444 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.21 score on a scale | Standard Deviation 0.847 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.52 score on a scale | Standard Deviation 0.964 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 Post-CAE | 2.56 score on a scale | Standard Deviation 0.559 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.25 score on a scale | Standard Deviation 0.555 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.72 score on a scale | Standard Deviation 0.798 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.48 score on a scale | Standard Deviation 0.622 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.37 score on a scale | Standard Deviation 0.787 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.65 score on a scale | Standard Deviation 0.822 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 8 | -0.27 score on a scale | Standard Deviation 0.592 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.27 score on a scale | Standard Deviation 0.743 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.45 score on a scale | Standard Deviation 0.724 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.23 score on a scale | Standard Deviation 0.662 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.34 score on a scale | Standard Deviation 0.658 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.19 score on a scale | Standard Deviation 0.713 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 0.791 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.10 score on a scale | Standard Deviation 0.707 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.07 score on a scale | Standard Deviation 0.604 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.29 score on a scale | Standard Deviation 0.615 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 Pre-CAE | 2.03 score on a scale | Standard Deviation 0.456 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 Post-CAE | 2.45 score on a scale | Standard Deviation 0.556 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.09 score on a scale | Standard Deviation 0.782 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.42 score on a scale | Standard Deviation 0.65 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.08 score on a scale | Standard Deviation 0.915 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 8 | -0.09 score on a scale | Standard Deviation 0.556 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
It is evaluated for the temporal region on the Ora Calibra® Corneal and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.30 score on a scale | Standard Deviation 0.679 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.34 score on a scale | Standard Deviation 0.569 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.49 score on a scale | Standard Deviation 0.739 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.46 score on a scale | Standard Deviation 0.523 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.19 score on a scale | Standard Deviation 0.706 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.15 score on a scale | Standard Deviation 0.835 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 Pre-CAE | 2.14 score on a scale | Standard Deviation 0.452 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 Post-CAE | 2.60 score on a scale | Standard Deviation 0.606 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.07 score on a scale | Standard Deviation 0.554 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 8 | -0.01 score on a scale | Standard Deviation 0.52 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.24 score on a scale | Standard Deviation 0.842 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.26 score on a scale | Standard Deviation 0.872 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.34 score on a scale | Standard Deviation 0.601 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.23 score on a scale | Standard Deviation 0.765 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 Pre-CAE | 2.12 score on a scale | Standard Deviation 0.521 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 Post-CAE | 2.42 score on a scale | Standard Deviation 0.538 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.30 score on a scale | Standard Deviation 0.647 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 8 | -0.09 score on a scale | Standard Deviation 0.598 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.31 score on a scale | Standard Deviation 0.741 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.54 score on a scale | Standard Deviation 0.683 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.18 score on a scale | Standard Deviation 0.828 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.38 score on a scale | Standard Deviation 0.653 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.33 score on a scale | Standard Deviation 0.894 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 57 (Pre-CAE) | 0.06 score on a scale | Standard Deviation 0.749 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.24 score on a scale | Standard Deviation 0.767 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.28 score on a scale | Standard Deviation 0.902 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.20 score on a scale | Standard Deviation 0.478 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 8 | -0.13 score on a scale | Standard Deviation 0.755 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.33 score on a scale | Standard Deviation 0.696 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.20 score on a scale | Standard Deviation 0.737 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.45 score on a scale | Standard Deviation 0.625 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 Pre-CAE | 2.02 score on a scale | Standard Deviation 0.622 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.09 score on a scale | Standard Deviation 0.754 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.40 score on a scale | Standard Deviation 0.857 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.54 score on a scale | Standard Deviation 0.552 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 Post-CAE | 2.47 score on a scale | Standard Deviation 0.519 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.10 score on a scale | Standard Deviation 0.714 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.14 score on a scale | Standard Deviation 0.736 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.26 score on a scale | Standard Deviation 0.824 |
Secondary
Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Total score was sum of all 5 regions: central, superior, inferior, temporal, and nasal. Individual region score was evaluated on the Ora Calibra® Corneal and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 20. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Post-CAE) | -1.88 score on a scale | Standard Deviation 2.4 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Post-CAE) | -1.93 score on a scale | Standard Deviation 1.831 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Post-CAE) | -2.73 score on a scale | Standard Deviation 2.875 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 (Change from Pre-CAE to Post-CAE) | 3.72 score on a scale | Standard Deviation 1.614 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Pre-CAE) | -0.61 score on a scale | Standard Deviation 2.933 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -1.77 score on a scale | Standard Deviation 2.686 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Pre-CAE | 9.85 score on a scale | Standard Deviation 1.852 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Post-CAE | 13.57 score on a scale | Standard Deviation 2.143 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Pre-CAE) | -0.04 score on a scale | Standard Deviation 2.25 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 8 | 0.15 score on a scale | Standard Deviation 2.139 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -1.84 score on a scale | Standard Deviation 2.763 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -2.05 score on a scale | Standard Deviation 2.53 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Pre-CAE) | -0.96 score on a scale | Standard Deviation 2.866 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -1.73 score on a scale | Standard Deviation 2.245 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Pre-CAE | 9.99 score on a scale | Standard Deviation 1.777 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Post-CAE | 12.99 score on a scale | Standard Deviation 1.828 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 (Change from Pre-CAE to Post-CAE) | 3.00 score on a scale | Standard Deviation 1.684 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 8 | -0.45 score on a scale | Standard Deviation 2.009 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Pre-CAE) | -1.49 score on a scale | Standard Deviation 2.312 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Post-CAE) | -3.22 score on a scale | Standard Deviation 2.664 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Pre-CAE) | -0.77 score on a scale | Standard Deviation 2.214 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Post-CAE) | -2.60 score on a scale | Standard Deviation 2.168 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -2.46 score on a scale | Standard Deviation 2.054 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Pre-CAE) | -0.07 score on a scale | Standard Deviation 2.403 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Post-CAE) | -2.06 score on a scale | Standard Deviation 2.99 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -1.91 score on a scale | Standard Deviation 2.922 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Post-CAE) | -1.11 score on a scale | Standard Deviation 1.739 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 8 | -0.29 score on a scale | Standard Deviation 2.667 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Post-CAE) | -1.87 score on a scale | Standard Deviation 2.559 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -1.30 score on a scale | Standard Deviation 2.403 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 (Change from Pre-CAE to Post-CAE) | 3.21 score on a scale | Standard Deviation 1.89 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Pre-CAE | 9.63 score on a scale | Standard Deviation 1.982 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Pre-CAE) | -0.74 score on a scale | Standard Deviation 2.56 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -1.82 score on a scale | Standard Deviation 2.676 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Post-CAE) | -2.50 score on a scale | Standard Deviation 2.15 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Post-CAE | 12.84 score on a scale | Standard Deviation 1.872 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Pre-CAE) | -0.30 score on a scale | Standard Deviation 2.71 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Pre-CAE) | -0.68 score on a scale | Standard Deviation 2.338 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -1.24 score on a scale | Standard Deviation 2.387 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal)
Total score was sum of all 5 regions: central, superior, inferior, temporal, and nasal. Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 20. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Post-CAE) | -1.14 score on a scale | Standard Deviation 2.635 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.21 score on a scale | Standard Deviation 2.551 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Post-CAE) | -1.87 score on a scale | Standard Deviation 3.156 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Pre-CAE) | -1.38 score on a scale | Standard Deviation 2.767 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.47 score on a scale | Standard Deviation 1.923 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.49 score on a scale | Standard Deviation 2.409 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.01 score on a scale | Standard Deviation 2.568 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Pre-CAE) | -1.13 score on a scale | Standard Deviation 1.815 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Post-CAE | 8.12 score on a scale | Standard Deviation 2.653 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Pre-CAE) | -1.31 score on a scale | Standard Deviation 2.435 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Pre-CAE | 6.65 score on a scale | Standard Deviation 2.277 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Post-CAE) | -0.83 score on a scale | Standard Deviation 2.369 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 8 | -0.36 score on a scale | Standard Deviation 2.124 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Post-CAE) | -1.12 score on a scale | Standard Deviation 2.455 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.21 score on a scale | Standard Deviation 2.016 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 8 | -1.27 score on a scale | Standard Deviation 2.065 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Pre-CAE) | -1.35 score on a scale | Standard Deviation 2.684 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Post-CAE | 7.99 score on a scale | Standard Deviation 2.753 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Post-CAE) | -1.77 score on a scale | Standard Deviation 3.087 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.24 score on a scale | Standard Deviation 3.138 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Pre-CAE) | -2.22 score on a scale | Standard Deviation 2.193 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Pre-CAE | 6.94 score on a scale | Standard Deviation 2.091 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Post-CAE) | -2.50 score on a scale | Standard Deviation 2.836 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.05 score on a scale | Standard Deviation 2.493 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.28 score on a scale | Standard Deviation 2.633 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Pre-CAE) | -1.39 score on a scale | Standard Deviation 2.038 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 2.716 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Pre-CAE | 6.61 score on a scale | Standard Deviation 2.223 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Post-CAE | 7.77 score on a scale | Standard Deviation 2.741 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.16 score on a scale | Standard Deviation 2.708 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 8 | -0.66 score on a scale | Standard Deviation 2.09 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Pre-CAE) | -1.79 score on a scale | Standard Deviation 3.059 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 15 (Post-CAE) | -1.72 score on a scale | Standard Deviation 2.607 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Pre-CAE) | -1.22 score on a scale | Standard Deviation 2.15 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.07 score on a scale | Standard Deviation 3.161 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 29 (Post-CAE) | -0.61 score on a scale | Standard Deviation 2.025 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.50 score on a scale | Standard Deviation 2.553 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Pre-CAE) | -1.16 score on a scale | Standard Deviation 2.616 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 57 (Post-CAE) | -1.05 score on a scale | Standard Deviation 2.424 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region)
It is evaluated for the central region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.03 score on a scale | Standard Deviation 0.68 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 8 | -0.13 score on a scale | Standard Deviation 0.676 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.23 score on a scale | Standard Deviation 0.555 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 57 (Post-CAE) | -0.14 score on a scale | Standard Deviation 0.602 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.09 score on a scale | Standard Deviation 0.652 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.13 score on a scale | Standard Deviation 0.72 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Day 1 Pre-CAE | 0.48 score on a scale | Standard Deviation 0.735 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 15 (Post-CAE) | -0.33 score on a scale | Standard Deviation 0.636 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.20 score on a scale | Standard Deviation 0.776 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.11 score on a scale | Standard Deviation 0.547 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.31 score on a scale | Standard Deviation 0.63 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 29 (Post-CAE) | -0.07 score on a scale | Standard Deviation 0.258 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Day 1 Post-CAE | 0.59 score on a scale | Standard Deviation 0.78 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.26 score on a scale | Standard Deviation 0.636 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.17 score on a scale | Standard Deviation 0.677 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Day 1 Pre-CAE | 0.57 score on a scale | Standard Deviation 0.742 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 29 (Post-CAE) | -0.15 score on a scale | Standard Deviation 0.66 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.31 score on a scale | Standard Deviation 0.667 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 8 | -0.29 score on a scale | Standard Deviation 0.582 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 15 (Post-CAE) | -0.29 score on a scale | Standard Deviation 0.706 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 57 (Post-CAE) | -0.34 score on a scale | Standard Deviation 0.898 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Day 1 Post-CAE | 0.60 score on a scale | Standard Deviation 0.735 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.22 score on a scale | Standard Deviation 0.837 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.02 score on a scale | Standard Deviation 0.879 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.03 score on a scale | Standard Deviation 0.815 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.03 score on a scale | Standard Deviation 0.519 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 15 (Post-CAE) | -0.30 score on a scale | Standard Deviation 0.647 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Day 1 Pre-CAE | 0.54 score on a scale | Standard Deviation 0.734 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Day 1 Post-CAE | 0.66 score on a scale | Standard Deviation 0.823 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.12 score on a scale | Standard Deviation 0.799 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 8 | -0.24 score on a scale | Standard Deviation 0.723 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.24 score on a scale | Standard Deviation 0.744 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.06 score on a scale | Standard Deviation 0.935 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.28 score on a scale | Standard Deviation 0.73 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 29 (Post-CAE) | -0.07 score on a scale | Standard Deviation 0.466 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.11 score on a scale | Standard Deviation 0.956 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.16 score on a scale | Standard Deviation 0.681 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from Baseline: Day 57 (Post-CAE) | -0.31 score on a scale | Standard Deviation 0.619 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Central Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.18 score on a scale | Standard Deviation 0.782 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum)
Conjunctival sum score is the sum of all regions of the conjunctiva (temporal and nasal regions). Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 8. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.00 score on a scale | Standard Deviation 1.553 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.38 score on a scale | Standard Deviation 1.175 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.47 score on a scale | Standard Deviation 1.356 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.54 score on a scale | Standard Deviation 1.417 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.09 score on a scale | Standard Deviation 1.668 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Day 1 Pre-CAE | 3.53 score on a scale | Standard Deviation 1.231 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 15 (Post-CAE) | -0.60 score on a scale | Standard Deviation 1.245 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.52 score on a scale | Standard Deviation 1.092 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.06 score on a scale | Standard Deviation 1.427 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.57 score on a scale | Standard Deviation 1.336 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Day 1 Post-CAE | 4.05 score on a scale | Standard Deviation 1.314 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.47 score on a scale | Standard Deviation 1.195 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 8 | -0.13 score on a scale | Standard Deviation 1.249 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Day 1 Pre-CAE | 3.59 score on a scale | Standard Deviation 1.058 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.60 score on a scale | Standard Deviation 1.2 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 8 | -0.36 score on a scale | Standard Deviation 1.197 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.17 score on a scale | Standard Deviation 1.223 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.51 score on a scale | Standard Deviation 1.349 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Day 1 Post-CAE | 3.76 score on a scale | Standard Deviation 1.322 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 15 (Post-CAE) | -0.79 score on a scale | Standard Deviation 1.228 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.38 score on a scale | Standard Deviation 1.577 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 29 (Post-CAE) | 0.04 score on a scale | Standard Deviation 1.264 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.96 score on a scale | Standard Deviation 1.056 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.59 score on a scale | Standard Deviation 1.09 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.21 score on a scale | Standard Deviation 1.461 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.17 score on a scale | Standard Deviation 1.524 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.02 score on a scale | Standard Deviation 1.723 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Day 1 Post-CAE | 3.80 score on a scale | Standard Deviation 1.262 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.50 score on a scale | Standard Deviation 1.403 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 8 | -0.15 score on a scale | Standard Deviation 1.133 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.69 score on a scale | Standard Deviation 1.548 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 15 (Post-CAE) | -0.74 score on a scale | Standard Deviation 1.084 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 1.724 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.22 score on a scale | Standard Deviation 1.112 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.36 score on a scale | Standard Deviation 1.154 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.07 score on a scale | Standard Deviation 1.412 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.26 score on a scale | Standard Deviation 1.222 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.24 score on a scale | Standard Deviation 1.377 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Conjunctival Sum) | Day 1 Pre-CAE | 3.30 score on a scale | Standard Deviation 1.237 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum)
Corneal sum score is the sum of all regions of the cornea (inferior, superior and central regions). Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 12. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.67 score on a scale | Standard Deviation 1.674 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.36 score on a scale | Standard Deviation 1.782 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 15 (Post-CAE) | -1.27 score on a scale | Standard Deviation 2.264 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.95 score on a scale | Standard Deviation 1.314 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.74 score on a scale | Standard Deviation 1.516 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.43 score on a scale | Standard Deviation 1.648 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Day 1 Pre-CAE | 3.12 score on a scale | Standard Deviation 1.272 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Day 1 Post-CAE | 4.07 score on a scale | Standard Deviation 1.705 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.75 score on a scale | Standard Deviation 1.228 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 8 | -0.23 score on a scale | Standard Deviation 1.258 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.08 score on a scale | Standard Deviation 1.494 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.21 score on a scale | Standard Deviation 1.578 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.84 score on a scale | Standard Deviation 1.633 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.45 score on a scale | Standard Deviation 1.952 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Day 1 Pre-CAE | 3.35 score on a scale | Standard Deviation 1.36 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Day 1 Post-CAE | 4.23 score on a scale | Standard Deviation 1.785 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.88 score on a scale | Standard Deviation 1.683 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 8 | -0.91 score on a scale | Standard Deviation 1.382 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 15 (Pre-CAE) | -1.26 score on a scale | Standard Deviation 1.568 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 15 (Post-CAE) | -1.71 score on a scale | Standard Deviation 2.118 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.79 score on a scale | Standard Deviation 1.487 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 29 (Post-CAE) | -1.15 score on a scale | Standard Deviation 1.754 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.81 score on a scale | Standard Deviation 1.588 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.84 score on a scale | Standard Deviation 1.751 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 57 (Post-CAE) | -1.38 score on a scale | Standard Deviation 1.936 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.45 score on a scale | Standard Deviation 2.154 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.25 score on a scale | Standard Deviation 1.43 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 8 | -0.51 score on a scale | Standard Deviation 1.375 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.81 score on a scale | Standard Deviation 1.439 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.57 score on a scale | Standard Deviation 1.783 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.66 score on a scale | Standard Deviation 1.701 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Day 1 Pre-CAE | 3.31 score on a scale | Standard Deviation 1.344 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.90 score on a scale | Standard Deviation 1.793 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.12 score on a scale | Standard Deviation 1.965 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 15 (Post-CAE) | -0.98 score on a scale | Standard Deviation 1.924 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Day 1 Post-CAE | 3.97 score on a scale | Standard Deviation 1.828 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 29 (Pre-CAE) | -1.00 score on a scale | Standard Deviation 1.488 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from Baseline: Day 15 (Pre-CAE) | -1.10 score on a scale | Standard Deviation 1.909 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Corneal Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.03 score on a scale | Standard Deviation 1.586 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region)
It is evaluated for the inferior region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Day 1 Pre-CAE | 1.42 score on a scale | Standard Deviation 0.642 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Day 1 Post-CAE | 2.00 score on a scale | Standard Deviation 0.92 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.58 score on a scale | Standard Deviation 0.752 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 8 | 0.04 score on a scale | Standard Deviation 0.699 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.46 score on a scale | Standard Deviation 1.228 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.12 score on a scale | Standard Deviation 0.982 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.14 score on a scale | Standard Deviation 0.815 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.10 score on a scale | Standard Deviation 1.191 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.10 score on a scale | Standard Deviation 1.064 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.21 score on a scale | Standard Deviation 0.637 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.16 score on a scale | Standard Deviation 0.943 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.04 score on a scale | Standard Deviation 0.881 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.34 score on a scale | Standard Deviation 0.805 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.17 score on a scale | Standard Deviation 0.869 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Day 1 Pre-CAE | 1.46 score on a scale | Standard Deviation 0.605 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.38 score on a scale | Standard Deviation 1.179 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.60 score on a scale | Standard Deviation 0.949 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Day 1 Post-CAE | 2.12 score on a scale | Standard Deviation 0.895 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.24 score on a scale | Standard Deviation 0.715 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.76 score on a scale | Standard Deviation 0.984 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.66 score on a scale | Standard Deviation 0.934 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.60 score on a scale | Standard Deviation 0.877 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.69 score on a scale | Standard Deviation 0.895 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 8 | -0.30 score on a scale | Standard Deviation 0.642 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.33 score on a scale | Standard Deviation 0.919 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.43 score on a scale | Standard Deviation 0.644 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.22 score on a scale | Standard Deviation 0.764 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.34 score on a scale | Standard Deviation 1.104 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.34 score on a scale | Standard Deviation 0.688 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.14 score on a scale | Standard Deviation 1.17 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.28 score on a scale | Standard Deviation 0.607 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.20 score on a scale | Standard Deviation 1.074 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.48 score on a scale | Standard Deviation 0.707 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Day 1 Pre-CAE | 1.50 score on a scale | Standard Deviation 0.58 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Day 1 Post-CAE | 1.87 score on a scale | Standard Deviation 0.826 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.16 score on a scale | Standard Deviation 1.147 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.37 score on a scale | Standard Deviation 0.85 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.07 score on a scale | Standard Deviation 0.866 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Inferior Region) | Change from Baseline: Day 8 | -0.08 score on a scale | Standard Deviation 0.702 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region)
It is evaluated for the nasal region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.26 score on a scale | Standard Deviation 0.815 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.19 score on a scale | Standard Deviation 0.737 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.23 score on a scale | Standard Deviation 0.858 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.28 score on a scale | Standard Deviation 0.64 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.28 score on a scale | Standard Deviation 0.679 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.01 score on a scale | Standard Deviation 0.901 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Day 1 Pre-CAE | 1.90 score on a scale | Standard Deviation 0.707 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Day 1 Post-CAE | 2.18 score on a scale | Standard Deviation 0.774 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.12 score on a scale | Standard Deviation 0.709 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 8 | -0.04 score on a scale | Standard Deviation 0.748 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.14 score on a scale | Standard Deviation 0.821 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.09 score on a scale | Standard Deviation 0.78 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.22 score on a scale | Standard Deviation 0.723 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.19 score on a scale | Standard Deviation 1.07 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Day 1 Pre-CAE | 1.96 score on a scale | Standard Deviation 0.561 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Day 1 Post-CAE | 2.05 score on a scale | Standard Deviation 0.828 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.09 score on a scale | Standard Deviation 0.74 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 8 | -0.25 score on a scale | Standard Deviation 0.668 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.48 score on a scale | Standard Deviation 0.66 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.29 score on a scale | Standard Deviation 0.904 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.39 score on a scale | Standard Deviation 0.638 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 29 (Post-CAE) | 0.10 score on a scale | Standard Deviation 0.749 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.52 score on a scale | Standard Deviation 0.781 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.31 score on a scale | Standard Deviation 0.692 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.16 score on a scale | Standard Deviation 0.843 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.17 score on a scale | Standard Deviation 0.872 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.11 score on a scale | Standard Deviation 0.854 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 8 | 0.00 score on a scale | Standard Deviation 0.677 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.02 score on a scale | Standard Deviation 0.841 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.02 score on a scale | Standard Deviation 1.004 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.24 score on a scale | Standard Deviation 0.816 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Day 1 Pre-CAE | 1.69 score on a scale | Standard Deviation 0.638 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.10 score on a scale | Standard Deviation 0.721 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.01 score on a scale | Standard Deviation 1.013 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.24 score on a scale | Standard Deviation 0.672 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Day 1 Post-CAE | 1.93 score on a scale | Standard Deviation 0.693 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.03 score on a scale | Standard Deviation 0.785 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.23 score on a scale | Standard Deviation 0.822 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Nasal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.05 score on a scale | Standard Deviation 0.959 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region)
It is evaluated for the superior region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.37 score on a scale | Standard Deviation 0.679 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.19 score on a scale | Standard Deviation 0.806 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.48 score on a scale | Standard Deviation 0.931 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.26 score on a scale | Standard Deviation 0.527 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.29 score on a scale | Standard Deviation 0.729 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.11 score on a scale | Standard Deviation 0.841 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Day 1 Pre-CAE | 1.22 score on a scale | Standard Deviation 0.507 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Day 1 Post-CAE | 1.48 score on a scale | Standard Deviation 0.58 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.32 score on a scale | Standard Deviation 0.541 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 8 | -0.14 score on a scale | Standard Deviation 0.525 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 0.797 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.14 score on a scale | Standard Deviation 0.789 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.37 score on a scale | Standard Deviation 0.838 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.08 score on a scale | Standard Deviation 0.808 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Day 1 Pre-CAE | 1.32 score on a scale | Standard Deviation 0.56 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Day 1 Post-CAE | 1.51 score on a scale | Standard Deviation 0.703 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.19 score on a scale | Standard Deviation 0.669 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 8 | -0.31 score on a scale | Standard Deviation 0.624 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.57 score on a scale | Standard Deviation 0.772 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.66 score on a scale | Standard Deviation 0.87 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.33 score on a scale | Standard Deviation 0.604 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.31 score on a scale | Standard Deviation 0.849 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.04 score on a scale | Standard Deviation 0.916 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.36 score on a scale | Standard Deviation 0.694 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.44 score on a scale | Standard Deviation 0.717 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 0.762 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 29 (Post-CAE) | 0.02 score on a scale | Standard Deviation 0.713 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 8 | -0.18 score on a scale | Standard Deviation 0.537 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.28 score on a scale | Standard Deviation 0.736 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.30 score on a scale | Standard Deviation 0.896 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.17 score on a scale | Standard Deviation 0.76 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Day 1 Pre-CAE | 1.27 score on a scale | Standard Deviation 0.546 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.40 score on a scale | Standard Deviation 0.769 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.04 score on a scale | Standard Deviation 0.936 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.34 score on a scale | Standard Deviation 0.866 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Day 1 Post-CAE | 1.44 score on a scale | Standard Deviation 0.697 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.44 score on a scale | Standard Deviation 0.712 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.38 score on a scale | Standard Deviation 0.907 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Superior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.08 score on a scale | Standard Deviation 0.915 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region)
It is evaluated for the temporal region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score.
Time frame: Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE)
Population: Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Day 1 Pre-CAE | 1.63 score on a scale | Standard Deviation 0.706 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Day 1 Post-CAE | 1.87 score on a scale | Standard Deviation 0.691 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.24 score on a scale | Standard Deviation 0.649 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 8 | -0.09 score on a scale | Standard Deviation 0.733 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.37 score on a scale | Standard Deviation 0.669 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 0.876 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.29 score on a scale | Standard Deviation 0.915 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.28 score on a scale | Standard Deviation 0.663 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.09 score on a scale | Standard Deviation 1.142 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.26 score on a scale | Standard Deviation 0.721 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.21 score on a scale | Standard Deviation 0.75 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.05 score on a scale | Standard Deviation 1.029 |
| 0.10% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.32 score on a scale | Standard Deviation 0.885 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.20 score on a scale | Standard Deviation 0.816 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Day 1 Pre-CAE | 1.63 score on a scale | Standard Deviation 0.669 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.03 score on a scale | Standard Deviation 0.947 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.08 score on a scale | Standard Deviation 0.688 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Day 1 Post-CAE | 1.71 score on a scale | Standard Deviation 0.671 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.21 score on a scale | Standard Deviation 0.683 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.50 score on a scale | Standard Deviation 0.772 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.08 score on a scale | Standard Deviation 0.695 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.22 score on a scale | Standard Deviation 0.934 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.06 score on a scale | Standard Deviation 0.668 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 8 | -0.11 score on a scale | Standard Deviation 0.864 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.02 score on a scale | Standard Deviation 0.928 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.48 score on a scale | Standard Deviation 0.707 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.22 score on a scale | Standard Deviation 0.715 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.50 score on a scale | Standard Deviation 0.606 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.16 score on a scale | Standard Deviation 0.71 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.04 score on a scale | Standard Deviation 0.919 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.19 score on a scale | Standard Deviation 0.63 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.25 score on a scale | Standard Deviation 0.569 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.46 score on a scale | Standard Deviation 0.885 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Day 1 Pre-CAE | 1.61 score on a scale | Standard Deviation 0.751 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Day 1 Post-CAE | 1.87 score on a scale | Standard Deviation 0.734 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 0.916 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.26 score on a scale | Standard Deviation 0.834 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.07 score on a scale | Standard Deviation 1.066 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (Temporal Region) | Change from Baseline: Day 8 | -0.15 score on a scale | Standard Deviation 0.686 |
Secondary
Ora Calibra® Drop Comfort Scale
Ora Calibra® drop comfort scale ranges from 0 to 10. A score of 0 indicates comfortable and 10 indicates uncomfortable. Lower score indicated better comfort level.
Time frame: Upon instillation and 1 and 2 minutes post-instillation on Day 1
Population: The ITT Population with available data. The analysis was carried out with observed data only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.10% HL036 Ophthalmic Solution | Ora Calibra® Drop Comfort Scale | 1 minute post-instillation on Day 1 | 2.0 score on a scale | Standard Deviation 1.86 |
| 0.10% HL036 Ophthalmic Solution | Ora Calibra® Drop Comfort Scale | Upon instillation on Day 1 | 2.8 score on a scale | Standard Deviation 2.25 |
| 0.10% HL036 Ophthalmic Solution | Ora Calibra® Drop Comfort Scale | 2 minutes post-instillation on Day 1 | 1.6 score on a scale | Standard Deviation 1.75 |
| 0.25% HL036 Ophthalmic Solution | Ora Calibra® Drop Comfort Scale | 1 minute post-instillation on Day 1 | 2.6 score on a scale | Standard Deviation 1.93 |
| 0.25% HL036 Ophthalmic Solution | Ora Calibra® Drop Comfort Scale | Upon instillation on Day 1 | 3.6 score on a scale | Standard Deviation 2.4 |
| 0.25% HL036 Ophthalmic Solution | Ora Calibra® Drop Comfort Scale | 2 minutes post-instillation on Day 1 | 2.3 score on a scale | Standard Deviation 1.91 |
| Placebo | Ora Calibra® Drop Comfort Scale | Upon instillation on Day 1 | 3.3 score on a scale | Standard Deviation 2.69 |
| Placebo | Ora Calibra® Drop Comfort Scale | 2 minutes post-instillation on Day 1 | 2.0 score on a scale | Standard Deviation 1.89 |
| Placebo | Ora Calibra® Drop Comfort Scale | 1 minute post-instillation on Day 1 | 2.3 score on a scale | Standard Deviation 1.84 |