Dry Eye
Conditions
Brief summary
The objective of this study was to compare the safety and efficacy of 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
BIOLOGICALPlacebo
Placebo vehicle solution
Sponsors
Daewoong Pharmaceutical Co. LTD.
HanAll BioPharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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 Visit 1 * Be willing and able to comply with all study procedures * Have 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 worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months * Have any previous experience using HL036
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE) | Pre-CAE and Post-CAE on Day 1 (Baseline) and Day 57 | It was evaluated for the inferior region on the Ora Calibra® 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. |
| 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® 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® 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® 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® 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® 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 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® 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 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). 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 Lissamine Green Staining 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). 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 Lissamine Green Staining 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). 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 Lissamine Green Staining 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). 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 Lissamine Green Staining 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). 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 Lissamine Green 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 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 (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. |
| Measure Title 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 | Post CAE on baseline (Day 1) and Days 15, 29, and 57 | The Schirmer test strip will be placed in the lower temporal lid margin of each eye. Participants 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 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 Ocular Surface Disease Index (OSDI) | Pre-CAE on baseline (Day 1) and Days 15, 29, and 57; Day 8 | 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. |
| Change From Baseline in Visual Analog Scale (Blurry 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 blurry 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 (Burning/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) | Participants rated ocular symptom of burning/stinging 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 Sensation) | 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 sensation 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 (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) | Participants rated ocular symptom of eye 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 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. At each day during the at-home dosing period, subjects will grade the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of overall ocular discomfort on 0 to 5 scale, where 0=none and 5=severe. |
| 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. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of burning on 0 to 5 scale, where 0=none and 5=severe. |
| 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. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of dryness on 0 to 5 scale, where 0=none and 5=severe. |
| 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. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of grittiness on 0 to 5 scale, where 0=none and 5=severe. |
| 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. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of stinging on 0 to 5 scale, where 0=none and 5=severe. |
| 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 Day -14 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® 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 Day -14 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 Day -14 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 Day -14 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 Day -14 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® 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 12 sites in the United States.
Pre-assignment details
A total of 1108 patients were screened and 637 patients were enrolled and randomized to one of the treatment groups. The enrollment number in Protocol refers to the participants randomized to the treatment group.
Participants by arm
| Arm | Count |
|---|---|
| 0.25% HL036 Ophthalmic Solution Participants self-administered HL036 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57. | 318 |
| Placebo Participants sefl-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57. | 319 |
| Total | 637 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Placebo Run-in (14 Days) | Eligibility Criteria Not Met | 465 | 0 | 0 |
| Placebo Run-in (14 Days) | Other | 2 | 0 | 0 |
| Placebo Run-in (14 Days) | Physician Decision | 1 | 0 | 0 |
| Placebo Run-in (14 Days) | Withdrawal by Subject | 3 | 0 | 0 |
| Randomized Treatment Period (Days 57±3) | Administrative Reasons | 0 | 2 | 4 |
| Randomized Treatment Period (Days 57±3) | Adverse Event | 0 | 16 | 8 |
| Randomized Treatment Period (Days 57±3) | Other | 0 | 1 | 4 |
| Randomized Treatment Period (Days 57±3) | Protocol Violation | 0 | 6 | 5 |
| Randomized Treatment Period (Days 57±3) | Withdrawal by Subject | 0 | 2 | 4 |
Baseline characteristics
| Characteristic | Placebo | Total | 0.25% HL036 Ophthalmic Solution |
|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 14.02 | 62.0 years STANDARD_DEVIATION 13.48 | 61.0 years STANDARD_DEVIATION 12.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 49 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 294 Participants | 588 Participants | 294 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 37 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 53 Participants | 124 Participants | 71 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 8 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 238 Participants | 466 Participants | 228 Participants |
| Sex: Female, Male Female | 211 Participants | 441 Participants | 230 Participants |
| Sex: Female, Male Male | 108 Participants | 196 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 318 | 0 / 319 |
| other Total, other adverse events | 78 / 318 | 76 / 319 |
| serious Total, serious adverse events | 5 / 318 | 4 / 319 |
Outcome results
Primary
Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE)
It was evaluated for the inferior region on the Ora Calibra® 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: Pre-CAE and Post-CAE on Day 1 (Baseline) and Day 57
Population: ITT Population with the Markov Chain Monte Carlo (MCMC) imputation method for missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.38 score on a scale | Standard Deviation 0.427 |
| 0.25% HL036 Ophthalmic Solution | Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.47 score on a scale | Standard Deviation 0.9 |
| Placebo | Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.31 score on a scale | Standard Deviation 0.411 |
| Placebo | Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.52 score on a scale | Standard Deviation 0.762 |
p-value: 0.187195% CI: [-0.04, 0.21]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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) | Day 1 Pre-CAE | 2.61 score on a scale | Standard Deviation 0.975 |
| 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) | -0.47 score on a scale | Standard Deviation 1.318 |
| Placebo | Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) | Day 1 Pre-CAE | 2.53 score on a scale | Standard Deviation 1.06 |
| Placebo | Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) | Change from Baseline: Day 57 (Pre-CAE) | -0.47 score on a scale | Standard Deviation 1.287 |
p-value: 0.554995% CI: [-0.12, 0.23]ANCOVA
Secondary
Change From Baseline in 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.3 mm | Standard Deviation 1.32 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 57 (Post-CAE) | -0.4 mm | Standard Deviation 0.91 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 29 (Post-CAE) | -0.2 mm | Standard Deviation 0.73 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.1 mm | Standard Deviation 1.41 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 15 (Post-CAE) | -0.2 mm | Standard Deviation 0.77 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Day 1 Pre-CAE | 2.6 mm | Standard Deviation 0.98 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.2 mm | Standard Deviation 1.44 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Day 1 Post-CAE | 3.6 mm | Standard Deviation 0.59 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 29 (Pre-CAE) | -0.4 mm | Standard Deviation 1.3 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Day 1 (Change from Pre-CAE to Post-CAE) | 1.0 mm | Standard Deviation 1.07 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 57 (Pre-CAE) | -0.5 mm | Standard Deviation 1.29 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 8 | -0.3 mm | Standard Deviation 1.2 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 15 (Pre-CAE) | -0.5 mm | Standard Deviation 1.18 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 8 | -0.2 mm | Standard Deviation 1.11 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 15 (Pre-CAE) | -0.3 mm | Standard Deviation 1.18 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 15 (Post-CAE) | -0.1 mm | Standard Deviation 0.74 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.1 mm | Standard Deviation 1.36 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 29 (Pre-CAE) | -0.2 mm | Standard Deviation 1.23 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 29 (Post-CAE) | -0.2 mm | Standard Deviation 0.84 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.0 mm | Standard Deviation 1.38 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 57 (Pre-CAE) | -0.5 mm | Standard Deviation 1.24 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Change from Baseline: Day 57 (Post-CAE) | -0.3 mm | Standard Deviation 0.95 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.2 mm | Standard Deviation 1.37 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Day 1 Pre-CAE | 2.5 mm | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Day 1 Post-CAE | 3.6 mm | Standard Deviation 0.64 |
| Placebo | Change From Baseline in Ocular Discomfort Scale | Day 1 (Change from Pre-CAE to Post-CAE) | 1.1 mm | Standard Deviation 1.12 |
Secondary
Change From Baseline in Ocular Surface 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: Pre-CAE on baseline (Day 1) and Days 15, 29, and 57; Day 8
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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface Disease Index (OSDI) | Change from Baseline: Day 8 | -2.0 score on a scale | Standard Deviation 12.5 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface Disease Index (OSDI) | Change from Baseline: Day 29 (Pre-CAE) | -3.7 score on a scale | Standard Deviation 13.13 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 1 Pre-CAE | 39.7 score on a scale | Standard Deviation 19.68 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface Disease Index (OSDI) | Change from Baseline: Day 57 (Pre-CAE) | -2.9 score on a scale | Standard Deviation 14.69 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ocular Surface Disease Index (OSDI) | Change from Baseline: Day 15 (Pre-CAE) | -2.7 score on a scale | Standard Deviation 12.07 |
| Placebo | Change From Baseline in Ocular Surface Disease Index (OSDI) | Change from Baseline: Day 57 (Pre-CAE) | -5.3 score on a scale | Standard Deviation 13.93 |
| Placebo | Change From Baseline in Ocular Surface Disease Index (OSDI) | Day 1 Pre-CAE | 39.2 score on a scale | Standard Deviation 19.33 |
| Placebo | Change From Baseline in Ocular Surface Disease Index (OSDI) | Change from Baseline: Day 8 | -1.5 score on a scale | Standard Deviation 12.46 |
| Placebo | Change From Baseline in Ocular Surface Disease Index (OSDI) | Change from Baseline: Day 15 (Pre-CAE) | -1.5 score on a scale | Standard Deviation 12.81 |
| Placebo | Change From Baseline in Ocular Surface Disease Index (OSDI) | Change from Baseline: Day 29 (Pre-CAE) | -2.2 score on a scale | Standard Deviation 13.95 |
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. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of burning on 0 to 5 scale, where 0=none and 5=severe.
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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 8 | -0.1 mm | 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 (Pre-CAE) | -0.2 mm | Standard Deviation 1.18 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 Pre-CAE | 1.7 mm | Standard Deviation 1.43 |
| 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) | -0.3 mm | 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 57 (Post-CAE) | -0.3 mm | Standard Deviation 1.37 |
| 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) | -0.1 mm | Standard Deviation 1.5 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 Post-CAE | 2.6 mm | Standard Deviation 1.56 |
| 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) | -0.3 mm | Standard Deviation 1.26 |
| 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) | -0.3 mm | 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 (Change from Pre-CAE to Post-CAE) | -0.1 mm | Standard Deviation 1.57 |
| 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 mm | Standard Deviation 1.34 |
| 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) | -0.3 mm | Standard Deviation 1.19 |
| 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) | 0.0 mm | Standard Deviation 1.49 |
| 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) | 0.0 mm | Standard Deviation 1.61 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 29 (Pre-CAE) | -0.2 mm | Standard Deviation 1.16 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 57 (Pre-CAE) | -0.4 mm | Standard Deviation 1.25 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 57 (Post-CAE) | -0.4 mm | Standard Deviation 1.36 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 Pre-CAE | 1.7 mm | Standard Deviation 1.38 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 Post-CAE | 2.6 mm | Standard Deviation 1.56 |
| 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) | 0.9 mm | Standard Deviation 1.22 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 15 (Pre-CAE) | -0.2 mm | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 15 (Post-CAE) | -0.3 mm | Standard Deviation 1.2 |
| 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 mm | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 29 (Post-CAE) | -0.3 mm | Standard Deviation 1.25 |
| 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) | -0.2 mm | Standard Deviation 1.55 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Change from Baseline: Day 8 | -0.2 mm | Standard Deviation 1.08 |
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. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of dryness on 0 to 5 scale, where 0=none and 5=severe.
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 |
|---|---|---|---|---|
| 0.25% 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) | 0.8 mm | Standard Deviation 0.97 |
| 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 mm | Standard Deviation 1.16 |
| 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) | -0.4 mm | 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 mm | Standard Deviation 0.91 |
| 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 mm | Standard Deviation 0.89 |
| 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) | 0.2 mm | Standard Deviation 1.22 |
| 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 mm | Standard Deviation 0.85 |
| 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) | -0.5 mm | Standard Deviation 1.22 |
| 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 | -0.2 mm | 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 57 (Post-CAE) | -0.4 mm | Standard Deviation 1.12 |
| 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) | 0.1 mm | 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 (Change from Pre-CAE to Post-CAE) | 0.1 mm | Standard Deviation 1.34 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 Pre-CAE | 3.2 mm | Standard Deviation 1.05 |
| 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 mm | Standard Deviation 1.34 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 Pre-CAE | 3.2 mm | Standard Deviation 0.97 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 Post-CAE | 3.9 mm | Standard Deviation 0.88 |
| 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) | 0.8 mm | Standard Deviation 0.95 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 8 | -0.3 mm | Standard Deviation 1.05 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 15 (Pre-CAE) | -0.4 mm | Standard Deviation 0.99 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 15 (Post-CAE) | -0.2 mm | Standard Deviation 0.78 |
| 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) | 0.1 mm | Standard Deviation 1.11 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 29 (Pre-CAE) | -0.4 mm | Standard Deviation 1.22 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 29 (Post-CAE) | -0.3 mm | Standard Deviation 0.92 |
| 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 mm | Standard Deviation 1.38 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 57 (Pre-CAE) | -0.6 mm | Standard Deviation 1.18 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Change from Baseline: Day 57 (Post-CAE) | -0.5 mm | Standard Deviation 1.1 |
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. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of grittiness on 0 to 5 scale, where 0=none and 5=severe.
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 |
|---|---|---|---|---|
| 0.25% 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) | -0.3 mm | Standard Deviation 1.12 |
| 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) | -0.4 mm | Standard Deviation 1.14 |
| 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) | 0.6 mm | Standard Deviation 1.14 |
| 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) | -0.3 mm | Standard Deviation 1.2 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 Pre-CAE | 2.1 mm | Standard Deviation 1.42 |
| 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) | 0.1 mm | Standard Deviation 1.4 |
| 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 | -0.3 mm | Standard Deviation 1.05 |
| 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) | -0.4 mm | Standard Deviation 1.15 |
| 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) | -0.3 mm | Standard Deviation 1.2 |
| 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) | -0.4 mm | 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 15 (Change from Pre-CAE to Post-CAE) | 0.0 mm | Standard Deviation 1.43 |
| 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) | 0.1 mm | Standard Deviation 1.37 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 Post-CAE | 2.7 mm | Standard Deviation 1.49 |
| 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) | 0.1 mm | Standard Deviation 1.46 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 15 (Pre-CAE) | -0.3 mm | 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 (Post-CAE) | -0.2 mm | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 Pre-CAE | 2.1 mm | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 Post-CAE | 2.6 mm | Standard Deviation 1.55 |
| 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) | 0.5 mm | Standard Deviation 1.16 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 8 | -0.2 mm | Standard Deviation 1.17 |
| 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) | 0.1 mm | Standard Deviation 1.31 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 29 (Pre-CAE) | -0.3 mm | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 29 (Post-CAE) | -0.3 mm | Standard Deviation 1.19 |
| 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 mm | Standard Deviation 1.37 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 57 (Pre-CAE) | -0.4 mm | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Change from Baseline: Day 57 (Post-CAE) | -0.3 mm | Standard Deviation 1.32 |
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. At each day during the at-home dosing period, subjects will grade the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of overall ocular discomfort on 0 to 5 scale, where 0=none and 5=severe.
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 |
|---|---|---|---|---|
| 0.25% 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 | -0.2 mm | Standard Deviation 1.05 |
| 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) | -0.4 mm | Standard Deviation 1.14 |
| 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 mm | Standard Deviation 0.82 |
| 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) | -0.3 mm | Standard Deviation 0.86 |
| 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) | -0.4 mm | 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) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.1 mm | Standard Deviation 1.29 |
| 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) | 0.9 mm | 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 57 (Pre-CAE) | -0.4 mm | Standard Deviation 1.21 |
| 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) | -0.2 mm | Standard Deviation 0.95 |
| 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) | -0.4 mm | Standard Deviation 1.01 |
| 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 | 2.8 mm | Standard Deviation 0.94 |
| 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) | 0.1 mm | Standard Deviation 1.31 |
| 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) | 0.2 mm | Standard Deviation 1.35 |
| 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 mm | Standard Deviation 1.21 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 Pre-CAE | 2.8 mm | Standard Deviation 1 |
| 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) | 0.9 mm | 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 8 | -0.2 mm | Standard Deviation 1.03 |
| 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) | -0.3 mm | Standard Deviation 0.99 |
| 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) | -0.3 mm | Standard Deviation 0.82 |
| 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) | 0.1 mm | 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 29 (Pre-CAE) | -0.3 mm | Standard Deviation 1.2 |
| 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) | -0.3 mm | Standard Deviation 0.89 |
| 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) | 0.0 mm | 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 57 (Pre-CAE) | -0.5 mm | Standard Deviation 1.14 |
| 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 mm | Standard Deviation 1.04 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 Post-CAE | 3.7 mm | Standard Deviation 0.79 |
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. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of stinging on 0 to 5 scale, where 0=none and 5=severe.
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 |
|---|---|---|---|---|
| 0.25% 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) | 0.8 mm | Standard Deviation 1.1 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 29 (Pre-CAE) | -0.3 mm | Standard Deviation 1.16 |
| 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 mm | Standard Deviation 1.07 |
| 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) | -0.3 mm | Standard Deviation 1.3 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 Post-CAE | 2.3 mm | Standard Deviation 1.55 |
| 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) | 0.0 mm | Standard Deviation 1.48 |
| 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) | -0.3 mm | Standard Deviation 1.15 |
| 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) | -0.4 mm | Standard Deviation 1.23 |
| 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 | -0.1 mm | 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) | -0.3 mm | 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 (Change from Pre-CAE to Post-CAE) | -0.1 mm | 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 57 (Change from Pre-CAE to Post-CAE) | 0.1 mm | Standard Deviation 1.38 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 Pre-CAE | 1.6 mm | Standard Deviation 1.42 |
| 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) | 0.0 mm | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 Pre-CAE | 1.6 mm | Standard Deviation 1.32 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 Post-CAE | 2.4 mm | Standard Deviation 1.52 |
| 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) | 0.8 mm | Standard Deviation 1.11 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 8 | -0.1 mm | Standard Deviation 1.03 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 15 (Pre-CAE) | -0.3 mm | Standard Deviation 1.01 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 15 (Post-CAE) | -0.3 mm | Standard Deviation 1.17 |
| 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) | 0.0 mm | Standard Deviation 1.32 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 29 (Pre-CAE) | -0.3 mm | Standard Deviation 1.05 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 29 (Post-CAE) | -0.5 mm | Standard Deviation 1.26 |
| 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 mm | Standard Deviation 1.38 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 57 (Pre-CAE) | -0.4 mm | Standard Deviation 1.09 |
| Placebo | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Change from Baseline: Day 57 (Post-CAE) | -0.5 mm | Standard Deviation 1.31 |
Secondary
Change From Baseline in Schirmer's Test
The Schirmer test strip will be placed in the lower temporal lid margin of each eye. Participants 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: Post CAE on baseline (Day 1) and 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Day 1 Post-CAE | 5.1 mm | Standard Deviation 2.8 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Change from Baseline: Day 15 (Post-CAE) | 1.2 mm | Standard Deviation 5.41 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Change from Baseline: Day 29 (Post-CAE) | 2.0 mm | Standard Deviation 6.14 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Schirmer's Test | Change from Baseline: Day 57 (Post-CAE) | 3.2 mm | Standard Deviation 7.55 |
| Placebo | Change From Baseline in Schirmer's Test | Change from Baseline: Day 57 (Post-CAE) | 2.4 mm | Standard Deviation 6.12 |
| Placebo | Change From Baseline in Schirmer's Test | Day 1 Post-CAE | 4.9 mm | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Schirmer's Test | Change from Baseline: Day 29 (Post-CAE) | 1.2 mm | Standard Deviation 5.26 |
| Placebo | Change From Baseline in Schirmer's Test | Change from Baseline: Day 15 (Post-CAE) | 2.0 mm | Standard Deviation 5.69 |
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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Day 1 (Change from Pre-CAE to Post-CAE) | -0.037 seconds | Standard Deviation 0.753 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 29 (Pre-CAE) | 0.311 seconds | Standard Deviation 1.3669 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 15 (Pre-CAE) | 0.276 seconds | Standard Deviation 1.4305 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 29 (Post-CAE) | 0.222 seconds | Standard Deviation 1.1373 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Day 1 Post-CAE | 2.444 seconds | Standard Deviation 0.8056 |
| 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) | -0.125 seconds | Standard Deviation 1.1118 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 15 (Post-CAE) | 0.340 seconds | Standard Deviation 1.4089 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 57 (Pre-CAE) | 0.610 seconds | Standard Deviation 1.3934 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 8 | 0.175 seconds | Standard Deviation 1.2459 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 57 (Post-CAE) | 0.523 seconds | Standard Deviation 1.1321 |
| 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) | 0.058 seconds | Standard Deviation 1.2997 |
| 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) | -0.085 seconds | Standard Deviation 1.3655 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Tear Film Break-Up Time | Day 1 Pre-CAE | 2.482 seconds | Standard Deviation 0.896 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.246 seconds | Standard Deviation 1.6429 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Day 1 Pre-CAE | 2.588 seconds | Standard Deviation 1.0003 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Day 1 Post-CAE | 2.504 seconds | Standard Deviation 0.9018 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Day 1 (Change from Pre-CAE to Post-CAE) | -0.084 seconds | Standard Deviation 0.8608 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 8 | 0.190 seconds | Standard Deviation 1.1859 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 15 (Pre-CAE) | 0.368 seconds | Standard Deviation 1.363 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 15 (Post-CAE) | 0.348 seconds | Standard Deviation 1.285 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.021 seconds | Standard Deviation 1.2701 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 29 (Pre-CAE) | 0.352 seconds | Standard Deviation 1.5754 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 29 (Post-CAE) | 0.302 seconds | Standard Deviation 1.2757 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.071 seconds | Standard Deviation 1.2797 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 57 (Pre-CAE) | 0.478 seconds | Standard Deviation 1.2693 |
| Placebo | Change From Baseline in Tear Film Break-Up Time | Change from Baseline: Day 57 (Post-CAE) | 0.726 seconds | Standard Deviation 1.6787 |
Secondary
Change From Baseline in Visual Analog Scale (Blurry Vision)
Participants rated ocular symptom of blurry 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Day 1 (Change from Pre-CAE to Post-CAE) | 5.9 mm | Standard Deviation 17.7 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 29 (Pre-CAE) | -3.9 mm | Standard Deviation 22.4 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 15 (Pre-CAE) | -2.8 mm | Standard Deviation 20.85 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 29 (Post-CAE) | -6.2 mm | Standard Deviation 22.3 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Day 1 Post-CAE | 43.7 mm | Standard Deviation 29.37 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -2.3 mm | Standard Deviation 22.41 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 15 (Post-CAE) | -3.9 mm | Standard Deviation 20.7 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 57 (Pre-CAE) | -6.5 mm | Standard Deviation 22.49 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 8 | -2.4 mm | Standard Deviation 18.85 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 57 (Post-CAE) | -7.1 mm | Standard Deviation 24.39 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.9 mm | Standard Deviation 23.3 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.3 mm | Standard Deviation 22.62 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Blurry Vision) | Day 1 Pre-CAE | 37.8 mm | Standard Deviation 28.41 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.2 mm | Standard Deviation 24.41 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Day 1 Pre-CAE | 32.9 mm | Standard Deviation 28.67 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Day 1 Post-CAE | 40.5 mm | Standard Deviation 29.68 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Day 1 (Change from Pre-CAE to Post-CAE) | 7.6 mm | Standard Deviation 18.8 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 8 | -0.8 mm | Standard Deviation 17.9 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 15 (Pre-CAE) | -1.3 mm | Standard Deviation 18.59 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 15 (Post-CAE) | -3.1 mm | Standard Deviation 18.99 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -2.1 mm | Standard Deviation 21.88 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 29 (Pre-CAE) | -1.3 mm | Standard Deviation 20.3 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 29 (Post-CAE) | -5.2 mm | Standard Deviation 21.84 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -3.9 mm | Standard Deviation 23.19 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 57 (Pre-CAE) | -5.7 mm | Standard Deviation 21.23 |
| Placebo | Change From Baseline in Visual Analog Scale (Blurry Vision) | Change from Baseline: Day 57 (Post-CAE) | -6.3 mm | Standard Deviation 24.68 |
Secondary
Change From Baseline in Visual Analog Scale (Burning/Stinging)
Participants rated ocular symptom of burning/stinging 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Day 1 (Change from Pre-CAE to Post-CAE) | 12.6 mm | Standard Deviation 24.32 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 29 (Pre-CAE) | -6.5 mm | Standard Deviation 24.75 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 15 (Pre-CAE) | -4.9 mm | Standard Deviation 21.12 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 29 (Post-CAE) | -5.2 mm | Standard Deviation 24.73 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Day 1 Post-CAE | 49.2 mm | Standard Deviation 31.81 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 1.5 mm | Standard Deviation 29.65 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 15 (Post-CAE) | -5.2 mm | Standard Deviation 23.93 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 57 (Pre-CAE) | -7.6 mm | Standard Deviation 23.03 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 8 | -3.7 mm | Standard Deviation 18.86 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 57 (Post-CAE) | -6.8 mm | Standard Deviation 26.31 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.1 mm | Standard Deviation 26.13 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 1.1 mm | Standard Deviation 28.56 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Day 1 Pre-CAE | 36.6 mm | Standard Deviation 28.19 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 1.8 mm | Standard Deviation 29.03 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Day 1 Pre-CAE | 35.6 mm | Standard Deviation 27.23 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Day 1 Post-CAE | 47.1 mm | Standard Deviation 30.02 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Day 1 (Change from Pre-CAE to Post-CAE) | 11.5 mm | Standard Deviation 23 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 8 | -3.9 mm | Standard Deviation 19.55 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 15 (Pre-CAE) | -5.7 mm | Standard Deviation 19.94 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 15 (Post-CAE) | -4.5 mm | Standard Deviation 23.8 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 1.5 mm | Standard Deviation 24.77 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 29 (Pre-CAE) | -5.4 mm | Standard Deviation 18.45 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 29 (Post-CAE) | -5.4 mm | Standard Deviation 24.5 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.6 mm | Standard Deviation 24.52 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 57 (Pre-CAE) | -9.1 mm | Standard Deviation 21.37 |
| Placebo | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Change from Baseline: Day 57 (Post-CAE) | -7.4 mm | Standard Deviation 27.83 |
Secondary
Change From Baseline in Visual Analog Scale (Eye Dryness)
Participants rated ocular symptom of eye 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Day 1 (Change from Pre-CAE to Post-CAE) | 13.1 mm | Standard Deviation 20.49 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 29 (Pre-CAE) | -9.8 mm | Standard Deviation 23.24 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 15 (Pre-CAE) | -7.7 mm | Standard Deviation 21.44 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 29 (Post-CAE) | -7.4 mm | Standard Deviation 20.28 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Day 1 Post-CAE | 74.4 mm | Standard Deviation 22.2 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 2.6 mm | Standard Deviation 25.92 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 15 (Post-CAE) | -5.4 mm | Standard Deviation 17.94 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 57 (Pre-CAE) | -12.9 mm | Standard Deviation 24.74 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 8 | -5.5 mm | Standard Deviation 19.57 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 57 (Post-CAE) | -10.6 mm | Standard Deviation 22.58 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 2.5 mm | Standard Deviation 23.52 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 2.3 mm | Standard Deviation 25.84 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Eye Dryness) | Day 1 Pre-CAE | 61.4 mm | Standard Deviation 24.71 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 1.2 mm | Standard Deviation 24.96 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Day 1 Pre-CAE | 59.7 mm | Standard Deviation 24.58 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Day 1 Post-CAE | 72.4 mm | Standard Deviation 21.45 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Day 1 (Change from Pre-CAE to Post-CAE) | 12.7 mm | Standard Deviation 18.58 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 8 | -3.7 mm | Standard Deviation 19.2 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 15 (Pre-CAE) | -6.8 mm | Standard Deviation 19.33 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 15 (Post-CAE) | -5.0 mm | Standard Deviation 17.45 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 1.9 mm | Standard Deviation 20.81 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 29 (Pre-CAE) | -7.4 mm | Standard Deviation 22.31 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 29 (Post-CAE) | -6.9 mm | Standard Deviation 19.91 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.6 mm | Standard Deviation 21.09 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 57 (Pre-CAE) | -11.3 mm | Standard Deviation 23.01 |
| Placebo | Change From Baseline in Visual Analog Scale (Eye Dryness) | Change from Baseline: Day 57 (Post-CAE) | -10.3 mm | Standard Deviation 24.63 |
Secondary
Change From Baseline in Visual Analog Scale (Foreign Body Sensation)
Participants rated ocular symptom of foreign body sensation 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Day 1 (Change from Pre-CAE to Post-CAE) | 9.7 mm | Standard Deviation 21.96 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 29 (Pre-CAE) | -6.9 mm | Standard Deviation 24.63 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 15 (Pre-CAE) | -5.5 mm | Standard Deviation 21.35 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 29 (Post-CAE) | -9.0 mm | Standard Deviation 26.1 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Day 1 Post-CAE | 47.5 mm | Standard Deviation 30.7 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -2.0 mm | Standard Deviation 28.75 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 15 (Post-CAE) | -7.9 mm | Standard Deviation 24.27 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 57 (Pre-CAE) | -7.6 mm | Standard Deviation 23.3 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 8 | -3.9 mm | Standard Deviation 19.98 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 57 (Post-CAE) | -9.1 mm | Standard Deviation 25.32 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -2.1 mm | Standard Deviation 25.53 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.9 mm | Standard Deviation 26.4 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Day 1 Pre-CAE | 37.8 mm | Standard Deviation 28.96 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 2.9 mm | Standard Deviation 25.6 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Day 1 Pre-CAE | 36.6 mm | Standard Deviation 28.81 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Day 1 Post-CAE | 42.9 mm | Standard Deviation 30.08 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Day 1 (Change from Pre-CAE to Post-CAE) | 6.3 mm | Standard Deviation 19.33 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 8 | -3.6 mm | Standard Deviation 21.88 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 15 (Pre-CAE) | -5.6 mm | Standard Deviation 21.37 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 15 (Post-CAE) | -2.9 mm | Standard Deviation 21.23 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 2.5 mm | Standard Deviation 23.43 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 29 (Pre-CAE) | -4.7 mm | Standard Deviation 22.85 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 29 (Post-CAE) | -4.0 mm | Standard Deviation 22.44 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.6 mm | Standard Deviation 22.51 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 57 (Pre-CAE) | -8.2 mm | Standard Deviation 22.7 |
| Placebo | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Change from Baseline: Day 57 (Post-CAE) | -5.6 mm | Standard Deviation 26.82 |
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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Day 1 (Change from Pre-CAE to Post-CAE) | 6.5 mm | Standard Deviation 21.23 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 29 (Pre-CAE) | -8.4 mm | Standard Deviation 22.61 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 15 (Pre-CAE) | -5.2 mm | Standard Deviation 22.62 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 29 (Post-CAE) | -7.8 mm | Standard Deviation 24.13 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Day 1 Post-CAE | 42.3 mm | Standard Deviation 30.44 |
| 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) | 0.5 mm | Standard Deviation 26.78 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 15 (Post-CAE) | -7.1 mm | Standard Deviation 21.79 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 57 (Pre-CAE) | -8.0 mm | Standard Deviation 21.7 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 8 | -5.1 mm | Standard Deviation 20.76 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 57 (Post-CAE) | -8.9 mm | Standard Deviation 24.09 |
| 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) | -2.0 mm | Standard Deviation 25.24 |
| 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) | -0.8 mm | Standard Deviation 24.68 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Itching) | Day 1 Pre-CAE | 35.9 mm | Standard Deviation 27.26 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 1.3 mm | Standard Deviation 26.04 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Day 1 Pre-CAE | 35.6 mm | Standard Deviation 27.53 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Day 1 Post-CAE | 39.6 mm | Standard Deviation 28.83 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Day 1 (Change from Pre-CAE to Post-CAE) | 4.0 mm | Standard Deviation 19.81 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 8 | -4.2 mm | Standard Deviation 19.66 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 15 (Pre-CAE) | -4.6 mm | Standard Deviation 21.02 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 15 (Post-CAE) | -3.7 mm | Standard Deviation 21.96 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 1.0 mm | Standard Deviation 23.34 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 29 (Pre-CAE) | -5.9 mm | Standard Deviation 20.75 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 29 (Post-CAE) | -5.9 mm | Standard Deviation 22.57 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.4 mm | Standard Deviation 22.52 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 57 (Pre-CAE) | -8.3 mm | Standard Deviation 23.57 |
| Placebo | Change From Baseline in Visual Analog Scale (Itching) | Change from Baseline: Day 57 (Post-CAE) | -7.2 mm | Standard Deviation 27.69 |
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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Day 1 (Change from Pre-CAE to Post-CAE) | 11.6 mm | Standard Deviation 22.26 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 29 (Pre-CAE) | -5.7 mm | Standard Deviation 22.52 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 15 (Pre-CAE) | -3.5 mm | Standard Deviation 20.36 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 29 (Post-CAE) | -6.3 mm | Standard Deviation 22.39 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Day 1 Post-CAE | 39.3 mm | Standard Deviation 31.31 |
| 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) | -0.6 mm | Standard Deviation 24.88 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 15 (Post-CAE) | -5.2 mm | Standard Deviation 23.17 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 57 (Pre-CAE) | -5.3 mm | Standard Deviation 21.66 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 8 | -3.7 mm | Standard Deviation 17.44 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 57 (Post-CAE) | -7.7 mm | Standard Deviation 25.24 |
| 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) | -1.3 mm | Standard Deviation 24.59 |
| 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) | -1.8 mm | Standard Deviation 25.64 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Pain) | Day 1 Pre-CAE | 27.7 mm | Standard Deviation 26.43 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.8 mm | Standard Deviation 26.5 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Day 1 Pre-CAE | 26.2 mm | Standard Deviation 25.34 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Day 1 Post-CAE | 37.0 mm | Standard Deviation 29.17 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Day 1 (Change from Pre-CAE to Post-CAE) | 10.8 mm | Standard Deviation 21.13 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 8 | -2.9 mm | Standard Deviation 19.27 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 15 (Pre-CAE) | -4.0 mm | Standard Deviation 19.52 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 15 (Post-CAE) | -5.8 mm | Standard Deviation 21.95 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -1.9 mm | Standard Deviation 21.55 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 29 (Pre-CAE) | -5.4 mm | Standard Deviation 20.52 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 29 (Post-CAE) | -9.0 mm | Standard Deviation 23.24 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -3.6 mm | Standard Deviation 23.73 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 57 (Pre-CAE) | -7.3 mm | Standard Deviation 22.61 |
| Placebo | Change From Baseline in Visual Analog Scale (Pain) | Change from Baseline: Day 57 (Post-CAE) | -8.3 mm | Standard Deviation 25.19 |
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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 (Change from Pre-CAE to Post-CAE) | 5.6 mm | Standard Deviation 19.67 |
| 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) | -0.4 mm | Standard Deviation 22.09 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 29 (Pre-CAE) | -6.3 mm | Standard Deviation 20.75 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 29 (Post-CAE) | -6.5 mm | Standard Deviation 21.85 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 8 | -3.2 mm | Standard Deviation 16.91 |
| 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) | 0.0 mm | Standard Deviation 22.25 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 Post-CAE | 46.0 mm | Standard Deviation 31.33 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 57 (Pre-CAE) | -7.4 mm | Standard Deviation 21.6 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 15 (Pre-CAE) | -3.4 mm | Standard Deviation 18.66 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 57 (Post-CAE) | -8.2 mm | Standard Deviation 22.51 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 Pre-CAE | 40.4 mm | Standard Deviation 30.2 |
| 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) | -0.4 mm | Standard Deviation 22.72 |
| 0.25% HL036 Ophthalmic Solution | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 15 (Post-CAE) | -4.0 mm | Standard Deviation 21.77 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -1.9 mm | Standard Deviation 22.26 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 Pre-CAE | 37.8 mm | Standard Deviation 30.73 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 Post-CAE | 43.5 mm | Standard Deviation 30.48 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Day 1 (Change from Pre-CAE to Post-CAE) | 5.7 mm | Standard Deviation 17.7 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 8 | -3.6 mm | Standard Deviation 17.03 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 15 (Pre-CAE) | -3.6 mm | Standard Deviation 18.58 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 15 (Post-CAE) | -4.9 mm | Standard Deviation 22.13 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 29 (Pre-CAE) | -4.9 mm | Standard Deviation 21.05 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 29 (Post-CAE) | -7.0 mm | Standard Deviation 23.42 |
| Placebo | 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 22.44 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 57 (Pre-CAE) | -7.6 mm | Standard Deviation 20.66 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from Baseline: Day 57 (Post-CAE) | -9.5 mm | Standard Deviation 23.72 |
| Placebo | Change From Baseline in Visual Analog Scale (Photophobia) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -1.3 mm | Standard Deviation 20.38 |
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 Day -14 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 8 - Day 14, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.58 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day -14 - Day -1 (Baseline) Daily Average | 1.9 score on a scale | Standard Deviation 1.21 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 - Day 7, Daily Average Change from Baseline | -0.1 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) | Day 15 - Day 21, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.63 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 22 - Day 28, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.69 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 29 - Day 35, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.71 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 36 - Day 42, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.73 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 43 - Day 49, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.78 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 50 - Day 56, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.82 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 43 - Day 49, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.87 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 36 - Day 42, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.83 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 22 - Day 28, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.75 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day -14 - Day -1 (Baseline) Daily Average | 1.8 score on a scale | Standard Deviation 1.21 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 50 - Day 56, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.92 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 1 - Day 7, Daily Average Change from Baseline | -0.1 score on a scale | Standard Deviation 0.53 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 8 - Day 14, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.6 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 29 - Day 35, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.8 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Day 15 - Day 21, Daily Average Change from Baseline | -0.2 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 (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 Day -14 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 - Day 7, Daily Average Change from Baseline | -0.1 score on a scale | Standard Deviation 0.47 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 29 - Day 35, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.78 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 15 - Day 21, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.66 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 36 - Day 42, Daily Average Change from Baseline | -0.5 score on a scale | Standard Deviation 0.81 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 8 - Day 14, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.58 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 43 - Day 49, Daily Average Change from Baseline | -0.5 score on a scale | Standard Deviation 0.88 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 22 - Day 28, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.74 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 50 - Day 56, Daily Average Change from Baseline | -0.5 score on a scale | Standard Deviation 0.88 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day -14 - Day -1 (Baseline) Daily Average | 3.0 score on a scale | Standard Deviation 0.94 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 50 - Day 56, Daily Average Change from Baseline | -0.5 score on a scale | Standard Deviation 0.93 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day -14 - Day -1 (Baseline) Daily Average | 2.9 score on a scale | Standard Deviation 0.97 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 1 - Day 7, Daily Average Change from Baseline | -0.1 score on a scale | Standard Deviation 0.46 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 8 - Day 14, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.57 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 15 - Day 21, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.68 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 22 - Day 28, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.74 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 29 - Day 35, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.77 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 36 - Day 42, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.84 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Day 43 - Day 49, Daily Average Change from Baseline | -0.5 score on a scale | Standard Deviation 0.88 |
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 Day -14 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 22 - Day 28, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.75 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 - Day 7, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.49 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 29 - Day 35, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.77 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day -14 - Day -1 (Baseline) Daily Average | 2.1 score on a scale | Standard Deviation 1.26 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 36 - Day 42, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.76 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 8 - Day 14, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.64 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 43 - Day 49, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.84 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 50 - Day 56, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.85 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 15 - Day 21, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.69 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 50 - Day 56, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.93 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 15 - Day 21, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.71 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 43 - Day 49, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.88 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day -14 - Day -1 (Baseline) Daily Average | 2.0 score on a scale | Standard Deviation 1.27 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 1 - Day 7, Daily Average Change from Baseline | -0.1 score on a scale | Standard Deviation 0.57 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 22 - Day 28, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.77 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 29 - Day 35, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.79 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 36 - Day 42, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.85 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Day 8 - Day 14, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.64 |
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 Day -14 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 29 - Day 35, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.76 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 43 - Day 49, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.83 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day -14 - Day -1 (Baseline) Daily Average | 2.7 score on a scale | Standard Deviation 0.96 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 - Day 7, Daily Average Change from Baseline | -0.1 score on a scale | Standard Deviation 0.49 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 8 - Day 14, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.56 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 15 - Day 21, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.66 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 22 - Day 28, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.71 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 36 - Day 42, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.77 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 50 - Day 56, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.83 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 36 - Day 42, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.85 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 29 - Day 35, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.8 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 15 - Day 21, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.7 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 43 - Day 49, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.89 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day -14 - Day -1 (Baseline) Daily Average | 2.7 score on a scale | Standard Deviation 1.02 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 22 - Day 28, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.79 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 1 - Day 7, Daily Average Change from Baseline | -0.1 score on a scale | Standard Deviation 0.52 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 50 - Day 56, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.93 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Day 8 - Day 14, Daily Average Change from Baseline | -0.1 score on a scale | Standard Deviation 0.58 |
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 Day -14 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 - Day 7, Daily Average Change from Baseline | -0.1 score on a scale | Standard Deviation 0.48 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 29 - Day 35, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.74 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 15 - Day 21, Daily Average Change from Baseline | -0.3 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 (Stinging) | Day 36 - Day 42, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.76 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day -14 - Day -1 (Baseline) Daily Average | 1.7 score on a scale | Standard Deviation 1.25 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 43 - Day 49, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.79 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 22 - Day 28, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.72 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 50 - Day 56, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.84 |
| 0.25% HL036 Ophthalmic Solution | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 8 - Day 14, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.62 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 50 - Day 56, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.86 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day -14 - Day -1 (Baseline) Daily Average | 1.7 score on a scale | Standard Deviation 1.23 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 1 - Day 7, Daily Average Change from Baseline | -0.1 score on a scale | Standard Deviation 0.53 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 8 - Day 14, Daily Average Change from Baseline | -0.2 score on a scale | Standard Deviation 0.6 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 15 - Day 21, Daily Average Change from Baseline | -0.3 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 (Stinging) | Day 22 - Day 28, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.7 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 29 - Day 35, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.73 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 36 - Day 42, Daily Average Change from Baseline | -0.3 score on a scale | Standard Deviation 0.79 |
| Placebo | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Day 43 - Day 49, Daily Average Change from Baseline | -0.4 score on a scale | Standard Deviation 0.82 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Central Region)
It is evaluated for the central region on the Ora Calibra® 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.07 score on a scale | Standard Deviation 0.944 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 Pre-CAE | 1.40 score on a scale | Standard Deviation 0.78 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 Post-CAE | 1.63 score on a scale | Standard Deviation 0.779 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.22 score on a scale | Standard Deviation 0.674 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 8 | -0.14 score on a scale | Standard Deviation 0.726 |
| 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 0.748 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 15 (Post-CAE) | -0.23 score on a scale | Standard Deviation 0.77 |
| 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) | 0.00 score on a scale | Standard Deviation 0.818 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.38 score on a scale | Standard Deviation 0.785 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 29 (Post-CAE) | -0.38 score on a scale | Standard Deviation 0.718 |
| 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) | -0.01 score on a scale | Standard Deviation 0.892 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.32 score on a scale | Standard Deviation 0.834 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 57 (Post-CAE) | -0.25 score on a scale | Standard Deviation 0.77 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.14 score on a scale | Standard Deviation 0.753 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.08 score on a scale | Standard Deviation 0.757 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 Pre-CAE | 1.36 score on a scale | Standard Deviation 0.654 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 57 (Post-CAE) | -0.29 score on a scale | Standard Deviation 0.687 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 Post-CAE | 1.66 score on a scale | Standard Deviation 0.721 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.23 score on a scale | Standard Deviation 0.737 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.30 score on a scale | Standard Deviation 0.552 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.18 score on a scale | Standard Deviation 0.758 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 8 | -0.02 score on a scale | Standard Deviation 0.746 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 29 (Post-CAE) | -0.38 score on a scale | Standard Deviation 0.643 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.17 score on a scale | Standard Deviation 0.694 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.10 score on a scale | Standard Deviation 0.867 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Central Region) | Change from Baseline: Day 15 (Post-CAE) | -0.24 score on a scale | Standard Deviation 0.742 |
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® 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 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.13 score on a scale | Standard Deviation 1.388 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 8 | -0.10 score on a scale | Standard Deviation 1.187 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.23 score on a scale | Standard Deviation 1.225 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.45 score on a scale | Standard Deviation 1.285 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 Pre-CAE | 3.33 score on a scale | Standard Deviation 1.327 |
| 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) | -0.22 score on a scale | Standard Deviation 1.501 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.31 score on a scale | Standard Deviation 1.336 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.22 score on a scale | Standard Deviation 1.332 |
| 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 1.084 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.27 score on a scale | Standard Deviation 1.345 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Post-CAE) | -0.44 score on a scale | Standard Deviation 1.308 |
| 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) | -0.07 score on a scale | Standard Deviation 1.479 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 Post-CAE | 4.05 score on a scale | Standard Deviation 1.305 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.12 score on a scale | Standard Deviation 1.432 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 Pre-CAE | 3.40 score on a scale | Standard Deviation 1.363 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 Post-CAE | 4.03 score on a scale | Standard Deviation 1.366 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.63 score on a scale | Standard Deviation 1.046 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 8 | -0.10 score on a scale | Standard Deviation 1.129 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.34 score on a scale | Standard Deviation 1.218 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Post-CAE) | -0.42 score on a scale | Standard Deviation 1.34 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.08 score on a scale | Standard Deviation 1.399 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.34 score on a scale | Standard Deviation 1.215 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.10 score on a scale | Standard Deviation 1.357 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.19 score on a scale | Standard Deviation 1.215 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.33 score on a scale | Standard Deviation 1.28 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.25 score on a scale | Standard Deviation 1.308 |
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® 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 29 (Post-CAE) | -1.42 score on a scale | Standard Deviation 1.698 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 Pre-CAE | 4.99 score on a scale | Standard Deviation 1.266 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 Post-CAE | 6.99 score on a scale | Standard Deviation 1.369 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.99 score on a scale | Standard Deviation 1.103 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 8 | -0.16 score on a scale | Standard Deviation 1.406 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.56 score on a scale | Standard Deviation 1.505 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 15 (Post-CAE) | -1.08 score on a scale | Standard Deviation 1.673 |
| 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) | -0.53 score on a scale | Standard Deviation 1.646 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.87 score on a scale | Standard Deviation 1.475 |
| 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) | -0.57 score on a scale | Standard Deviation 1.737 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.82 score on a scale | Standard Deviation 1.664 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 57 (Post-CAE) | -1.20 score on a scale | Standard Deviation 1.84 |
| 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) | -0.39 score on a scale | Standard Deviation 1.853 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 57 (Post-CAE) | -1.31 score on a scale | Standard Deviation 1.603 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.62 score on a scale | Standard Deviation 1.562 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 Pre-CAE | 5.01 score on a scale | Standard Deviation 1.123 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.56 score on a scale | Standard Deviation 1.645 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 Post-CAE | 7.01 score on a scale | Standard Deviation 1.359 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.78 score on a scale | Standard Deviation 1.63 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 2.00 score on a scale | Standard Deviation 1.065 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 29 (Post-CAE) | -1.47 score on a scale | Standard Deviation 1.519 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 8 | -0.18 score on a scale | Standard Deviation 1.475 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.74 score on a scale | Standard Deviation 1.811 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.57 score on a scale | Standard Deviation 1.436 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.68 score on a scale | Standard Deviation 1.644 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Change from Baseline: Day 15 (Post-CAE) | -1.17 score on a scale | Standard Deviation 1.576 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Inferior Region)
It is evaluated for the inferior region on the Ora Calibra® 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.47 score on a scale | Standard Deviation 0.829 |
| 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) | -0.48 score on a scale | Standard Deviation 0.84 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 Pre-CAE | 1.78 score on a scale | Standard Deviation 0.55 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 Post-CAE | 3.17 score on a scale | Standard Deviation 0.548 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 8 | 0.08 score on a scale | Standard Deviation 0.626 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.08 score on a scale | Standard Deviation 0.73 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.54 score on a scale | Standard Deviation 0.797 |
| 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) | -0.46 score on a scale | Standard Deviation 0.843 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.14 score on a scale | Standard Deviation 0.651 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.60 score on a scale | Standard Deviation 0.851 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.13 score on a scale | Standard Deviation 0.734 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.60 score on a scale | Standard Deviation 0.855 |
| 0.25% 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 0.427 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.12 score on a scale | Standard Deviation 0.713 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.69 score on a scale | Standard Deviation 0.771 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.58 score on a scale | Standard Deviation 0.703 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.53 score on a scale | Standard Deviation 0.709 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.49 score on a scale | Standard Deviation 0.795 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 Pre-CAE | 1.84 score on a scale | Standard Deviation 0.527 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.44 score on a scale | Standard Deviation 0.746 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 Post-CAE | 3.15 score on a scale | Standard Deviation 0.546 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 1.31 score on a scale | Standard Deviation 0.411 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.65 score on a scale | Standard Deviation 0.734 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 8 | -0.02 score on a scale | Standard Deviation 0.637 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.19 score on a scale | Standard Deviation 0.741 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.14 score on a scale | Standard Deviation 0.648 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Nasal Region)
It is evaluated for the nasal region on the Ora Calibra® 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.39 score on a scale | Standard Deviation 0.666 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.11 score on a scale | Standard Deviation 0.714 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.13 score on a scale | Standard Deviation 0.748 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.23 score on a scale | Standard Deviation 0.779 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 Post-CAE | 2.10 score on a scale | Standard Deviation 0.76 |
| 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) | -0.12 score on a scale | Standard Deviation 0.896 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.20 score on a scale | Standard Deviation 0.82 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.11 score on a scale | Standard Deviation 0.743 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 8 | -0.04 score on a scale | Standard Deviation 0.665 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.16 score on a scale | Standard Deviation 0.837 |
| 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) | -0.07 score on a scale | Standard Deviation 0.861 |
| 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) | -0.06 score on a scale | Standard Deviation 0.891 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 Pre-CAE | 1.71 score on a scale | Standard Deviation 0.74 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.06 score on a scale | Standard Deviation 0.886 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 Pre-CAE | 1.73 score on a scale | Standard Deviation 0.756 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 Post-CAE | 2.08 score on a scale | Standard Deviation 0.813 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.35 score on a scale | Standard Deviation 0.663 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 8 | -0.03 score on a scale | Standard Deviation 0.673 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.14 score on a scale | Standard Deviation 0.69 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.18 score on a scale | Standard Deviation 0.797 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.04 score on a scale | Standard Deviation 0.883 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.14 score on a scale | Standard Deviation 0.733 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.17 score on a scale | Standard Deviation 0.787 |
| Placebo | 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 0.837 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.08 score on a scale | Standard Deviation 0.706 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.15 score on a scale | Standard Deviation 0.76 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Superior Region)
It is evaluated for the superior region on the Ora Calibra® 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.39 score on a scale | Standard Deviation 0.629 |
| 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) | -0.08 score on a scale | Standard Deviation 0.8 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.36 score on a scale | Standard Deviation 0.677 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.35 score on a scale | Standard Deviation 0.652 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 8 | -0.10 score on a scale | Standard Deviation 0.665 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.44 score on a scale | Standard Deviation 0.774 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 Post-CAE | 2.19 score on a scale | Standard Deviation 0.614 |
| 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) | -0.09 score on a scale | Standard Deviation 0.887 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.24 score on a scale | Standard Deviation 0.665 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.35 score on a scale | Standard Deviation 0.779 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 Pre-CAE | 1.81 score on a scale | Standard Deviation 0.617 |
| 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) | 0.01 score on a scale | Standard Deviation 0.88 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.31 score on a scale | Standard Deviation 0.732 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.11 score on a scale | Standard Deviation 0.902 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 Pre-CAE | 1.82 score on a scale | Standard Deviation 0.556 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 Post-CAE | 2.20 score on a scale | Standard Deviation 0.638 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.39 score on a scale | Standard Deviation 0.625 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 8 | -0.15 score on a scale | Standard Deviation 0.639 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.26 score on a scale | Standard Deviation 0.616 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.35 score on a scale | Standard Deviation 0.735 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.09 score on a scale | Standard Deviation 0.836 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.36 score on a scale | Standard Deviation 0.677 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.41 score on a scale | Standard Deviation 0.681 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.26 score on a scale | Standard Deviation 0.672 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.37 score on a scale | Standard Deviation 0.71 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Superior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 0.738 |
Secondary
Mean Change From Baseline in Fluorescein Staining (Temporal Region)
It is evaluated for the temporal region on the Ora Calibra® 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.33 score on a scale | Standard Deviation 0.636 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.12 score on a scale | Standard Deviation 0.7 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.18 score on a scale | Standard Deviation 0.76 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.22 score on a scale | Standard Deviation 0.691 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 Post-CAE | 1.94 score on a scale | Standard Deviation 0.692 |
| 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) | -0.10 score on a scale | Standard Deviation 0.852 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.25 score on a scale | Standard Deviation 0.705 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.10 score on a scale | Standard Deviation 0.775 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 8 | -0.06 score on a scale | Standard Deviation 0.714 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.11 score on a scale | Standard Deviation 0.73 |
| 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) | -0.06 score on a scale | Standard Deviation 0.84 |
| 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) | -0.01 score on a scale | Standard Deviation 0.907 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 Pre-CAE | 1.62 score on a scale | Standard Deviation 0.701 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.07 score on a scale | Standard Deviation 0.838 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 Pre-CAE | 1.67 score on a scale | Standard Deviation 0.738 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 Post-CAE | 1.95 score on a scale | Standard Deviation 0.704 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.28 score on a scale | Standard Deviation 0.6 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 8 | -0.07 score on a scale | Standard Deviation 0.683 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.20 score on a scale | Standard Deviation 0.726 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.24 score on a scale | Standard Deviation 0.715 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 0.801 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.11 score on a scale | Standard Deviation 0.756 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.17 score on a scale | Standard Deviation 0.691 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.07 score on a scale | Standard Deviation 0.818 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.11 score on a scale | Standard Deviation 0.715 |
| Placebo | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.18 score on a scale | Standard Deviation 0.698 |
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® 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 |
|---|---|---|---|---|
| 0.25% 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) | 2.71 score on a scale | Standard Deviation 1.668 |
| 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) | -0.66 score on a scale | Standard Deviation 2.393 |
| 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) | -0.46 score on a scale | Standard Deviation 2.693 |
| 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) | -1.10 score on a scale | Standard Deviation 2.298 |
| 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 | -0.26 score on a scale | Standard Deviation 2.191 |
| 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) | -1.87 score on a scale | Standard Deviation 2.496 |
| 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 | 11.03 score on a scale | Standard Deviation 2.164 |
| 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) | -0.79 score on a scale | Standard Deviation 2.618 |
| 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) | -0.87 score on a scale | Standard Deviation 2.462 |
| 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) | -1.03 score on a scale | Standard Deviation 2.522 |
| 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 | 8.33 score on a scale | Standard Deviation 2.209 |
| 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) | -1.48 score on a scale | Standard Deviation 2.711 |
| 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) | -1.53 score on a scale | Standard Deviation 2.442 |
| 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) | -0.86 score on a scale | Standard Deviation 2.739 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Pre-CAE | 8.41 score on a scale | Standard Deviation 2.075 |
| Placebo | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Post-CAE | 11.04 score on a scale | Standard Deviation 2.246 |
| 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) | 2.63 score on a scale | Standard Deviation 1.703 |
| 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 2.208 |
| 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) | -0.91 score on a scale | Standard Deviation 2.296 |
| 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) | -1.59 score on a scale | Standard Deviation 2.44 |
| 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) | -0.70 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) | Change from Baseline: Day 29 (Pre-CAE) | -1.02 score on a scale | Standard Deviation 2.521 |
| 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) | -1.82 score on a scale | Standard Deviation 2.288 |
| 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) | -0.78 score on a scale | Standard Deviation 2.423 |
| 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) | -0.75 score on a scale | Standard Deviation 2.445 |
| 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) | -1.64 score on a scale | Standard Deviation 2.423 |
Secondary
Mean Change From Baseline in Lissamine Green 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 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.47 score on a scale | Standard Deviation 1.08 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.44 score on a scale | Standard Deviation 1.263 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.30 score on a scale | Standard Deviation 1.271 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.51 score on a scale | Standard Deviation 1.22 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Day 1 Post-CAE | 3.28 score on a scale | Standard Deviation 1.52 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.10 score on a scale | Standard Deviation 1.409 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Post-CAE) | -0.25 score on a scale | Standard Deviation 1.232 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.35 score on a scale | Standard Deviation 1.315 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 8 | -0.21 score on a scale | Standard Deviation 1.235 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.38 score on a scale | Standard Deviation 1.453 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.05 score on a scale | Standard Deviation 1.442 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.04 score on a scale | Standard Deviation 1.581 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Day 1 Pre-CAE | 2.81 score on a scale | Standard Deviation 1.428 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.14 score on a scale | Standard Deviation 1.51 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Day 1 Pre-CAE | 2.83 score on a scale | Standard Deviation 1.436 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Day 1 Post-CAE | 3.37 score on a scale | Standard Deviation 1.551 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.54 score on a scale | Standard Deviation 1.181 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 8 | -0.15 score on a scale | Standard Deviation 1.241 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.34 score on a scale | Standard Deviation 1.335 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 15 (Post-CAE) | -0.46 score on a scale | Standard Deviation 1.142 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.16 score on a scale | Standard Deviation 1.351 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.41 score on a scale | Standard Deviation 1.269 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.67 score on a scale | Standard Deviation 1.261 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.25 score on a scale | Standard Deviation 1.442 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.38 score on a scale | Standard Deviation 1.245 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.51 score on a scale | Standard Deviation 1.383 |
Secondary
Mean Change From Baseline in Lissamine Green 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 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.98 score on a scale | Standard Deviation 1.522 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.37 score on a scale | Standard Deviation 1.513 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.32 score on a scale | Standard Deviation 1.594 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.44 score on a scale | Standard Deviation 1.688 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Day 1 Post-CAE | 3.22 score on a scale | Standard Deviation 2.083 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.09 score on a scale | Standard Deviation 1.899 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 15 (Post-CAE) | -0.37 score on a scale | Standard Deviation 1.696 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.48 score on a scale | Standard Deviation 1.502 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 8 | -0.04 score on a scale | Standard Deviation 1.663 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.55 score on a scale | Standard Deviation 1.676 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.04 score on a scale | Standard Deviation 1.875 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.06 score on a scale | Standard Deviation 1.833 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Day 1 Pre-CAE | 2.24 score on a scale | Standard Deviation 1.711 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.12 score on a scale | Standard Deviation 1.9 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Day 1 Pre-CAE | 2.33 score on a scale | Standard Deviation 1.621 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Day 1 Post-CAE | 3.27 score on a scale | Standard Deviation 2.082 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.95 score on a scale | Standard Deviation 1.433 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 8 | -0.16 score on a scale | Standard Deviation 1.644 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 15 (Pre-CAE) | -0.30 score on a scale | Standard Deviation 1.599 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 15 (Post-CAE) | -0.39 score on a scale | Standard Deviation 1.846 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.08 score on a scale | Standard Deviation 1.933 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 29 (Pre-CAE) | -0.47 score on a scale | Standard Deviation 1.555 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 29 (Post-CAE) | -0.52 score on a scale | Standard Deviation 1.805 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 1.884 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 57 (Pre-CAE) | -0.51 score on a scale | Standard Deviation 1.473 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Change from Baseline: Day 57 (Post-CAE) | -0.63 score on a scale | Standard Deviation 1.609 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Score (Central Region)
It is evaluated for the central region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Day 1 Post-CAE | 0.55 score on a scale | Standard Deviation 0.698 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.02 score on a scale | Standard Deviation 0.705 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 8 | -0.02 score on a scale | Standard Deviation 0.662 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.11 score on a scale | Standard Deviation 0.671 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.02 score on a scale | Standard Deviation 0.784 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 29 (Post-CAE) | -0.12 score on a scale | Standard Deviation 0.554 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.11 score on a scale | Standard Deviation 0.62 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.16 score on a scale | Standard Deviation 0.65 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.15 score on a scale | Standard Deviation 0.587 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 57 (Post-CAE) | -0.17 score on a scale | Standard Deviation 0.623 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 15 (Post-CAE) | -0.08 score on a scale | Standard Deviation 0.631 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.01 score on a scale | Standard Deviation 0.749 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Day 1 Pre-CAE | 0.39 score on a scale | Standard Deviation 0.691 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 0.783 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 29 (Post-CAE) | -0.17 score on a scale | Standard Deviation 0.616 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Day 1 Pre-CAE | 0.39 score on a scale | Standard Deviation 0.646 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Day 1 Post-CAE | 0.57 score on a scale | Standard Deviation 0.731 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.18 score on a scale | Standard Deviation 0.559 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 8 | -0.04 score on a scale | Standard Deviation 0.625 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.04 score on a scale | Standard Deviation 0.663 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 15 (Post-CAE) | -0.08 score on a scale | Standard Deviation 0.698 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.04 score on a scale | Standard Deviation 0.788 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.08 score on a scale | Standard Deviation 0.586 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.09 score on a scale | Standard Deviation 0.683 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.12 score on a scale | Standard Deviation 0.608 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | Change from Baseline: Day 57 (Post-CAE) | -0.17 score on a scale | Standard Deviation 0.595 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region)
It is evaluated for the inferior region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 8 | 0.03 score on a scale | Standard Deviation 0.771 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.09 score on a scale | Standard Deviation 0.725 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Day 1 Pre-CAE | 1.03 score on a scale | Standard Deviation 0.72 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.15 score on a scale | Standard Deviation 1.071 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.67 score on a scale | Standard Deviation 0.918 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.07 score on a scale | Standard Deviation 1.078 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.14 score on a scale | Standard Deviation 1.035 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.11 score on a scale | Standard Deviation 0.744 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Day 1 Post-CAE | 1.71 score on a scale | Standard Deviation 1.084 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.20 score on a scale | Standard Deviation 1.015 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 1.088 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.09 score on a scale | Standard Deviation 1.064 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.08 score on a scale | Standard Deviation 0.723 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.03 score on a scale | Standard Deviation 1.142 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Day 1 Pre-CAE | 1.12 score on a scale | Standard Deviation 0.754 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Day 1 Post-CAE | 1.72 score on a scale | Standard Deviation 1.008 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.60 score on a scale | Standard Deviation 0.922 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 8 | -0.05 score on a scale | Standard Deviation 0.799 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.13 score on a scale | Standard Deviation 0.796 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.18 score on a scale | Standard Deviation 1.045 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.05 score on a scale | Standard Deviation 1.207 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.21 score on a scale | Standard Deviation 0.812 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.19 score on a scale | Standard Deviation 1.041 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.01 score on a scale | Standard Deviation 1.169 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.21 score on a scale | Standard Deviation 0.793 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.25 score on a scale | Standard Deviation 0.953 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region)
It is evaluated for the nasal region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.03 score on a scale | Standard Deviation 0.894 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.29 score on a scale | Standard Deviation 0.68 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.24 score on a scale | Standard Deviation 0.801 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.07 score on a scale | Standard Deviation 0.896 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.28 score on a scale | Standard Deviation 0.804 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 8 | -0.09 score on a scale | Standard Deviation 0.732 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.16 score on a scale | Standard Deviation 0.772 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.17 score on a scale | Standard Deviation 0.751 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Day 1 Post-CAE | 1.80 score on a scale | Standard Deviation 0.903 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.20 score on a scale | Standard Deviation 0.898 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.14 score on a scale | Standard Deviation 0.808 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.04 score on a scale | Standard Deviation 0.985 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Day 1 Pre-CAE | 1.51 score on a scale | Standard Deviation 0.852 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.13 score on a scale | Standard Deviation 0.862 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Day 1 Pre-CAE | 1.48 score on a scale | Standard Deviation 0.823 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Day 1 Post-CAE | 1.82 score on a scale | Standard Deviation 0.915 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.34 score on a scale | Standard Deviation 0.697 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.16 score on a scale | Standard Deviation 0.695 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.23 score on a scale | Standard Deviation 0.729 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.09 score on a scale | Standard Deviation 0.83 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.22 score on a scale | Standard Deviation 0.69 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.37 score on a scale | Standard Deviation 0.81 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.16 score on a scale | Standard Deviation 0.905 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.16 score on a scale | Standard Deviation 0.657 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.29 score on a scale | Standard Deviation 0.816 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | Change from Baseline: Day 8 | -0.07 score on a scale | Standard Deviation 0.655 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Score (Superior Region)
It is evaluated for the superior region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.03 score on a scale | Standard Deviation 0.78 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Day 1 Pre-CAE | 0.81 score on a scale | Standard Deviation 0.71 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Day 1 Post-CAE | 0.96 score on a scale | Standard Deviation 0.806 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.15 score on a scale | Standard Deviation 0.587 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 8 | -0.04 score on a scale | Standard Deviation 0.662 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.13 score on a scale | Standard Deviation 0.66 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.15 score on a scale | Standard Deviation 0.634 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.01 score on a scale | Standard Deviation 0.785 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.17 score on a scale | Standard Deviation 0.598 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.17 score on a scale | Standard Deviation 0.644 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.00 score on a scale | Standard Deviation 0.793 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.21 score on a scale | Standard Deviation 0.62 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.18 score on a scale | Standard Deviation 0.605 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | 0.03 score on a scale | Standard Deviation 0.792 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.01 score on a scale | Standard Deviation 0.78 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Day 1 Pre-CAE | 0.82 score on a scale | Standard Deviation 0.695 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 57 (Post-CAE) | -0.22 score on a scale | Standard Deviation 0.62 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Day 1 Post-CAE | 0.98 score on a scale | Standard Deviation 0.82 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.18 score on a scale | Standard Deviation 0.639 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.17 score on a scale | Standard Deviation 0.569 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.18 score on a scale | Standard Deviation 0.606 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 8 | -0.07 score on a scale | Standard Deviation 0.674 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 29 (Post-CAE) | -0.16 score on a scale | Standard Deviation 0.709 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.13 score on a scale | Standard Deviation 0.675 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.03 score on a scale | Standard Deviation 0.805 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | Change from Baseline: Day 15 (Post-CAE) | -0.13 score on a scale | Standard Deviation 0.739 |
Secondary
Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region)
It is evaluated for the temporal region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.18 score on a scale | Standard Deviation 0.601 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.21 score on a scale | Standard Deviation 0.687 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.14 score on a scale | Standard Deviation 0.733 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.22 score on a scale | Standard Deviation 0.659 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Day 1 Post-CAE | 1.47 score on a scale | Standard Deviation 0.798 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.03 score on a scale | Standard Deviation 0.811 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.11 score on a scale | Standard Deviation 0.714 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.18 score on a scale | Standard Deviation 0.774 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 8 | -0.12 score on a scale | Standard Deviation 0.708 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.18 score on a scale | Standard Deviation 0.774 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | 0.03 score on a scale | Standard Deviation 0.865 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | 0.00 score on a scale | Standard Deviation 0.868 |
| 0.25% HL036 Ophthalmic Solution | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Day 1 Pre-CAE | 1.29 score on a scale | Standard Deviation 0.734 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.02 score on a scale | Standard Deviation 1.023 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Day 1 Pre-CAE | 1.35 score on a scale | Standard Deviation 0.759 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Day 1 Post-CAE | 1.55 score on a scale | Standard Deviation 0.85 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Day 1 (Change from Pre-CAE to Post-CAE) | 0.21 score on a scale | Standard Deviation 0.752 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 8 | -0.07 score on a scale | Standard Deviation 0.811 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 15 (Pre-CAE) | -0.18 score on a scale | Standard Deviation 0.806 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 15 (Post-CAE) | -0.23 score on a scale | Standard Deviation 0.715 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.07 score on a scale | Standard Deviation 0.887 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 29 (Pre-CAE) | -0.19 score on a scale | Standard Deviation 0.827 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 29 (Post-CAE) | -0.29 score on a scale | Standard Deviation 0.78 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.09 score on a scale | Standard Deviation 0.918 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 57 (Pre-CAE) | -0.21 score on a scale | Standard Deviation 0.817 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | Change from Baseline: Day 57 (Post-CAE) | -0.23 score on a scale | Standard Deviation 0.822 |
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 |
|---|---|---|---|---|
| 0.25% 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) | 0.01 score on a scale | Standard Deviation 2.624 |
| 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) | -0.82 score on a scale | Standard Deviation 2.302 |
| 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 | -0.25 score on a scale | Standard Deviation 2.445 |
| 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) | -0.94 score on a scale | Standard Deviation 2.389 |
| 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 | 5.04 score on a scale | Standard Deviation 2.765 |
| 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) | -0.19 score on a scale | Standard Deviation 2.695 |
| 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) | -0.62 score on a scale | Standard Deviation 2.435 |
| 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) | -0.83 score on a scale | Standard Deviation 2.366 |
| 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) | 1.45 score on a scale | Standard Deviation 2.111 |
| 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) | -0.93 score on a scale | Standard Deviation 2.586 |
| 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) | -0.62 score on a scale | Standard Deviation 2.384 |
| 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) | -0.11 score on a scale | Standard Deviation 2.812 |
| 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 | 6.49 score on a scale | Standard Deviation 3.166 |
| 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) | -0.26 score on a scale | Standard Deviation 2.773 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Pre-CAE | 5.15 score on a scale | Standard Deviation 2.643 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Day 1 Post-CAE | 6.64 score on a scale | Standard Deviation 3.18 |
| 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) | 1.49 score on a scale | Standard Deviation 2.067 |
| Placebo | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Change from Baseline: Day 8 | -0.31 score on a scale | Standard Deviation 2.468 |
| 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) | -0.63 score on a scale | Standard Deviation 2.568 |
| 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) | -0.85 score on a scale | Standard Deviation 2.424 |
| 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) | -0.88 score on a scale | Standard Deviation 2.376 |
| 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) | -1.19 score on a scale | Standard Deviation 2.464 |
| 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) | -0.30 score on a scale | Standard Deviation 2.555 |
| 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) | -0.89 score on a scale | Standard Deviation 2.217 |
| 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) | -1.15 score on a scale | Standard Deviation 2.518 |
| 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) | -0.25 score on a scale | Standard Deviation 2.593 |
Secondary
Measure Title 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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 Pre-CAE | 1.53 score on a scale | Standard Deviation 0.588 |
| 0.25% HL036 Ophthalmic Solution | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 Post-CAE | 1.89 score on a scale | Standard Deviation 0.718 |
| 0.25% HL036 Ophthalmic Solution | Measure Title 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 0.511 |
| 0.25% HL036 Ophthalmic Solution | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 8 | -0.13 score on a scale | Standard Deviation 0.595 |
| 0.25% HL036 Ophthalmic Solution | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 15 (Pre-CAE) | -0.22 score on a scale | Standard Deviation 0.65 |
| 0.25% HL036 Ophthalmic Solution | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 15 (Post-CAE) | -0.37 score on a scale | Standard Deviation 0.691 |
| 0.25% HL036 Ophthalmic Solution | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.14 score on a scale | Standard Deviation 0.63 |
| 0.25% HL036 Ophthalmic Solution | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 29 (Pre-CAE) | -0.15 score on a scale | Standard Deviation 0.609 |
| 0.25% HL036 Ophthalmic Solution | Measure Title 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 0.729 |
| 0.25% HL036 Ophthalmic Solution | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.17 score on a scale | Standard Deviation 0.666 |
| 0.25% HL036 Ophthalmic Solution | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 57 (Pre-CAE) | 0.04 score on a scale | Standard Deviation 0.565 |
| 0.25% HL036 Ophthalmic Solution | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 57 (Post-CAE) | -0.07 score on a scale | Standard Deviation 0.579 |
| 0.25% HL036 Ophthalmic Solution | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.10 score on a scale | Standard Deviation 0.656 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 29 (Change from Pre-CAE to Post-CAE) | -0.18 score on a scale | Standard Deviation 0.62 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 Post-CAE | 1.95 score on a scale | Standard Deviation 0.739 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 15 (Change from Pre-CAE to Post-CAE) | -0.17 score on a scale | Standard Deviation 0.578 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 Pre-CAE | 1.55 score on a scale | Standard Deviation 0.617 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 57 (Post-CAE) | -0.26 score on a scale | Standard Deviation 0.561 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 29 (Pre-CAE) | -0.16 score on a scale | Standard Deviation 0.607 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Day 1 (Change from Pre-CAE to Post-CAE) | 0.40 score on a scale | Standard Deviation 0.503 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 57 (Pre-CAE) | -0.05 score on a scale | Standard Deviation 0.494 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 8 | -0.10 score on a scale | Standard Deviation 0.528 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 29 (Post-CAE) | -0.36 score on a scale | Standard Deviation 0.781 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from Baseline: Day 15 (Pre-CAE) | -0.18 score on a scale | Standard Deviation 0.596 |
| Placebo | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | -0.21 score on a scale | Standard Deviation 0.677 |
| Placebo | Measure Title 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 0.706 |
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 |
|---|---|---|---|---|
| 0.25% HL036 Ophthalmic Solution | Ora Calibra® Drop Comfort Scale | Upon instillation on Day 1 | 3.5 score on a scale | Standard Deviation 2.75 |
| 0.25% HL036 Ophthalmic Solution | Ora Calibra® Drop Comfort Scale | 1 minute post-instillation on Day 1 | 2.5 score on a scale | Standard Deviation 2.32 |
| 0.25% HL036 Ophthalmic Solution | Ora Calibra® Drop Comfort Scale | 2 minutes post-instillation on Day 1 | 2.1 score on a scale | Standard Deviation 2.19 |
| Placebo | Ora Calibra® Drop Comfort Scale | Upon instillation on Day 1 | 3.5 score on a scale | Standard Deviation 2.79 |
| Placebo | Ora Calibra® Drop Comfort Scale | 1 minute post-instillation on Day 1 | 2.5 score on a scale | Standard Deviation 2.12 |
| Placebo | Ora Calibra® Drop Comfort Scale | 2 minutes post-instillation on Day 1 | 2.0 score on a scale | Standard Deviation 2.02 |