Dry Eye Disease
Conditions
Brief summary
The objective of this study is to compare the safety and efficacy of two different concentrations of ST-100 Ophthalmic Solution to placebo (vehicle) for the treatment of the signs and symptoms of dry eye.
Detailed description
This is a Phase 2, multi-center, double-masked, randomized, placebo-controlled clinical study. Subjects will be randomized to one of the following treatment arms at Visit 2 (Day 1): * Low dose ST-100 Ophthalmic Solution: 1 drop twice daily (BID) in each eye * High dose ST-100 Ophthalmic Solution: 1 drop BID in each eye * Placebo Ophthalmic Solution (Vehicle): 1 drop BID in each eye Approximately 150 subjects will be randomly assigned to one of the three groups (1:1:1) to receive either ST-100 Ophthalmic Solution or placebo solution as topical ophthalmic drops administered bilaterally BID for 4 weeks. Subjects, Sponsor, Contract Research Organization (CRO), and site personnel will be masked to treatment assignment. The clinical hypotheses for this study is that low dose and high dose ST-100 Ophthalmic Solution twice daily (BID) is superior to its vehicle (BID) for the primary endpoints of signs and symptoms of dry eye.
Interventions
DRUGST-100 Ophthalmic Solution
One drop in each eye twice a day
DRUGPlacebo Ophthalmic Solution
One drop in each eye twice a day
Sponsors
ORA, Inc.
Stuart Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age; * Provide written informed consent; * Have a subject reported history of dry eye; * Have a history of use of eye drops for dry eye symptoms; * Have symptoms of dry eye as determined by Ocular Discomfort & 4-symptom questionnaire; * Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm; * Have conjunctival redness; * Have corneal fluorescein staining; * Have lissamine green conjunctival staining; * Have signs and symptoms responses to Controlled Adverse Environment (CAE®);
Exclusion criteria
* Have any clinically significant slit lamp findings; * Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation ; * Have worn contact lenses; * Have used any eye drops; * Have previously had laser-assisted in situ keratomileusis (LASIK) surgery * Have used Restasis, Xiidra, or Cequa ophthalmic solutions * Have any planned ocular and/or lid surgeries or any ocular surgery; * Have used, are using or anticipate using permanent or temporary punctal plugs during the study; * Be currently taking any topical ophthalmic prescription; * Be currently taking or have taken Omega-3 supplements; * Be unable to read an eye chart; * Be a woman who is pregnant, nursing, or planning a pregnancy; * Be unwilling to submit a urine pregnancy test (or early termination visit) if of childbearing potential; * Be a woman of childbearing potential who is not using an acceptable means of birth control; * Have a known allergy and/or sensitivity to the test article or its components; * Have a condition or be in a situation that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; * Be currently enrolled in an investigational drug or device study or have used an investigational drug or device; * Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen; * Have a known history of meibomian gland procedures (e.g., LipiFlow, LPI, probing, etc.); * Be unable or unwilling to follow instructions, including participation in all study assessments and visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE) | Visit 2 (Day 1) to Visit 7 (Day 29) | The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate 3 corneal regions. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The scoring reported ranges from 0-12. Mean change from baseline was calculated. |
| Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE | Visit 2 (Day 1) to Visit 7 (Day 29) | Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision) | Visit 4 (Day 4), Non-CAE | Ocular Surface Disease Index (OSDI) Questions 4: Have you experienced blurred vision during the last week? on 0-4 Scale where 4 is the worst at pre-CAE® |
| Unanesthetized Schirmer's Responder Rate | Visit 7 (Day 29), Pre-CAE | The Schirmer's test strip is placed in the lower temporal lid margin of each eye. After 5 minutes, the test strip is removed and the length of the moistened area will be recorded in millimeters (mm) for each eye. The percentage of responders who had ≥ 10 mm increase from baseline in study eye in unanesthetized Schirmer's test was recorded. |
| Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire | Visit 6 (Day 15) Pre-CAE | The Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire is used, which includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranges from 0 to 5, where 0 = None and 5 = Worst. Higher score means worse symptom. Min score = 0, max score = 25. |
| Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain) | Visit 6 (Day 15) Pre-CAE | Ocular Surface Disease Index (OSDI) Questions 3: Have you experienced painful or sore eyes during the last week? on 0-4 Scale where 4 is the worst at pre-CAE® |
| Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2) | Visit 3 (Day 2) | LogMAR visual acuity (VA) is assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The last line in which a letter is read correctly will be taken as the base logMAR reading. To this value will be added the number N x 0.02 where 'N' represents the total number of letters missed up to and included in the last line read. This total sum represents the logMAR VA for that eye. |
Countries
United States
Participant flow
Pre-assignment details
All participants participated in the run-in phase of the study before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Low Dose ST-100 Ophthalmic Solution Low Dose ST100-001 Ophthalmic solution, 20mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day | 53 |
| High Dose ST-100 Ophthalmic Solution High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day | 53 |
| Placebo Ophthalmic Solution Placebo Ophthalmic Solution (vehicle)
Placebo Ophthalmic Solution: One drop in each eye twice a day | 54 |
| Total | 160 |
Baseline characteristics
| Characteristic | Low Dose ST-100 Ophthalmic Solution | Total | Placebo Ophthalmic Solution | High Dose ST-100 Ophthalmic Solution |
|---|---|---|---|---|
| Age, Continuous | 64.4 years STANDARD_DEVIATION 10.29 | 63.2 years STANDARD_DEVIATION 11.77 | 63.4 years STANDARD_DEVIATION 13.28 | 61.9 years STANDARD_DEVIATION 11.6 |
| Ocular Discomfort Scale | 2.6 units on a scale STANDARD_DEVIATION 1.06 | 2.5 units on a scale STANDARD_DEVIATION 1.07 | 2.5 units on a scale STANDARD_DEVIATION 1.11 | 2.4 units on a scale STANDARD_DEVIATION 1.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 48 Participants | 18 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 109 Participants | 36 Participants | 38 Participants |
| Sex: Female, Male Female | 40 Participants | 112 Participants | 43 Participants | 29 Participants |
| Sex: Female, Male Male | 13 Participants | 48 Participants | 11 Participants | 24 Participants |
| Total Corneal Fluorescein Staining | 4.78 units on a scale STANDARD_DEVIATION 0.781 | 4.82 units on a scale STANDARD_DEVIATION 0.937 | 4.81 units on a scale STANDARD_DEVIATION 0.928 | 4.86 units on a scale STANDARD_DEVIATION 1.094 |
| Unanesthetized Schirmer's test | 4.4 mm STANDARD_DEVIATION 2.77 | 4.9 mm STANDARD_DEVIATION 2.83 | 5.0 mm STANDARD_DEVIATION 2.87 | 5.2 mm STANDARD_DEVIATION 2.84 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 53 | 1 / 54 | 0 / 160 |
| other Total, other adverse events | 6 / 52 | 6 / 53 | 8 / 54 | 0 / 160 |
| serious Total, serious adverse events | 1 / 52 | 0 / 53 | 2 / 54 | 0 / 160 |
Outcome results
Primary
Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE
Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort.
Time frame: Visit 2 (Day 1) to Visit 7 (Day 29)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE | -0.3 score on a scale | Standard Error 0.14 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE | -0.4 score on a scale | Standard Error 0.13 |
| Placebo Ophthalmic Solution | Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE | -0.3 score on a scale | Standard Error 0.14 |
p-value: 0.5696ANCOVA
Primary
Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE)
The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate 3 corneal regions. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The scoring reported ranges from 0-12. Mean change from baseline was calculated.
Time frame: Visit 2 (Day 1) to Visit 7 (Day 29)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE) | -0.17 units on a scale | Standard Error 0.186 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE) | -0.17 units on a scale | Standard Error 0.182 |
| Placebo Ophthalmic Solution | Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE) | -0.18 units on a scale | Standard Error 0.185 |
p-value: 0.9575ANCOVA
p-value: 0.9741ANCOVA
Secondary
Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire
The Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire is used, which includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranges from 0 to 5, where 0 = None and 5 = Worst. Higher score means worse symptom. Min score = 0, max score = 25.
Time frame: Visit 6 (Day 15) Pre-CAE
Population: The measurements are reported for each visit. The number of subjects in each group varied slightly at each visit. The overall analyzed number of participants were from the ITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire | -0.2 score on a scale | Standard Error 0.11 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire | -0.4 score on a scale | Standard Error 0.11 |
| Placebo Ophthalmic Solution | Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire | 0.0 score on a scale | Standard Error 0.11 |
p-value: 0.0332ANCOVA
Secondary
Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2)
LogMAR visual acuity (VA) is assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The last line in which a letter is read correctly will be taken as the base logMAR reading. To this value will be added the number N x 0.02 where 'N' represents the total number of letters missed up to and included in the last line read. This total sum represents the logMAR VA for that eye.
Time frame: Visit 3 (Day 2)
Population: The measurements are reported for each visit. The number of subjects in each group varied at each visit. The overall analyzed number of participants are from the ITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2) | -0.003 logMAR | Standard Error 0.0104 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2) | -0.028 logMAR | Standard Error 0.0104 |
| Placebo Ophthalmic Solution | Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2) | 0013 logMAR | Standard Error 0.0103 |
p-value: 0.0055ANCOVA
Secondary
Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision)
Ocular Surface Disease Index (OSDI) Questions 4: Have you experienced blurred vision during the last week? on 0-4 Scale where 4 is the worst at pre-CAE®
Time frame: Visit 4 (Day 4), Non-CAE
Population: The measurements are reported for each visit. The number of subjects in each group varied at each visit. The overall analyzed number of participants are from the ITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision) | -0.1 score on a scale | Standard Error 0.12 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision) | -0.3 score on a scale | Standard Error 0.12 |
| Placebo Ophthalmic Solution | Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision) | 0.2 score on a scale | Standard Error 0.12 |
p-value: 0.0097ANCOVA
Secondary
Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain)
Ocular Surface Disease Index (OSDI) Questions 3: Have you experienced painful or sore eyes during the last week? on 0-4 Scale where 4 is the worst at pre-CAE®
Time frame: Visit 6 (Day 15) Pre-CAE
Population: The measurements are reported for each visit. The number of subjects in each group varied slightly at each visit. The overall number analyzed are reported based on the ITT population.~\-
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain) | -0.1 score on a scale | Standard Error 0.11 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain) | -0.4 score on a scale | Standard Error 0.11 |
| Placebo Ophthalmic Solution | Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain) | 0.0 score on a scale | Standard Error 0.11 |
p-value: 0.0137ANCOVA
Secondary
Unanesthetized Schirmer's Responder Rate
The Schirmer's test strip is placed in the lower temporal lid margin of each eye. After 5 minutes, the test strip is removed and the length of the moistened area will be recorded in millimeters (mm) for each eye. The percentage of responders who had ≥ 10 mm increase from baseline in study eye in unanesthetized Schirmer's test was recorded.
Time frame: Visit 7 (Day 29), Pre-CAE
Population: The measurements are reported for each visit. The number of subjects in each group varied at each visit. The overall analyzed number of participants are from the ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Unanesthetized Schirmer's Responder Rate | 48 Participants |
| High Dose ST-100 Ophthalmic Solution | Unanesthetized Schirmer's Responder Rate | 49 Participants |
| Placebo Ophthalmic Solution | Unanesthetized Schirmer's Responder Rate | 48 Participants |
p-value: 0.0266Fisher Exact
Post Hoc
Change From Baseline in Fluorescein Staining in Conjunctival Sum - Both Eyes Together
The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate inferior, superior, central, temporal, and nasal region. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The corneal sum score is the sum of scores from the inferior, superior, and central regions (min 0, max 12). The conjunctival sum score is the sum of scores from the nasal and temporal regions (min 0, max 8). The total eye score is the sum of scores from all five regions (min 0, max 20). The average values of both eyes assessment were reported (min 0, max 20).
Time frame: Visit 7 (Day 28), Pre CAE
Population: The analysis was done on both study and fellow eyes combined
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Fluorescein Staining in Conjunctival Sum - Both Eyes Together | -0.01 units on a scale | Standard Deviation 0.793 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Fluorescein Staining in Conjunctival Sum - Both Eyes Together | -0.14 units on a scale | Standard Deviation 1.057 |
| Placebo Ophthalmic Solution | Change From Baseline in Fluorescein Staining in Conjunctival Sum - Both Eyes Together | 0.17 units on a scale | Standard Deviation 1.007 |
p-value: 0.0121Wilcoxon (Mann-Whitney)
Post Hoc
Change From Baseline in Fluorescein Staining in the Temporal Region - Both Eyes Together
The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate inferior, superior, central, temporal, and nasal region. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. This assessment reported the staining score in temporal region using the Corneal and Conjunctival Fluorescein Staining Scale (min 0, max 4). The average values of both eyes assessment were reported (min 0, max 4).
Time frame: Visit 7 (Day 28), Pre-CAE
Population: The count is based on the study and fellow eyes combined
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Fluorescein Staining in the Temporal Region - Both Eyes Together | -0.07 units on a scale | Standard Deviation 0.479 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Fluorescein Staining in the Temporal Region - Both Eyes Together | -0.07 units on a scale | Standard Deviation 0.644 |
| Placebo Ophthalmic Solution | Change From Baseline in Fluorescein Staining in the Temporal Region - Both Eyes Together | 0.12 units on a scale | Standard Deviation 0.593 |
p-value: 0.0224Wilcoxon (Mann-Whitney)
Post Hoc
Change From Baseline in Fluorescein Staining in the Total Eye Sum - Both Eyes Together
The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate inferior, superior, central, temporal, and nasal region. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The corneal sum score is the sum of scores from the inferior, superior, and central regions (min 0, max 12). The conjunctival sum score is the sum of scores from the nasal and temporal regions (min 0, max 8). The total eye score is the sum of scores from all five regions (min 0, max 20). The average values of both eyes assessment were reported (min 0, max 20)
Time frame: Visit 7 (Day 28) Pre CAE
Population: The analysis was done on both study and fellow eyes combined
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Fluorescein Staining in the Total Eye Sum - Both Eyes Together | -0.33 units on a scale | Standard Deviation 1.66 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Fluorescein Staining in the Total Eye Sum - Both Eyes Together | -0.42 units on a scale | Standard Deviation 1.81 |
| Placebo Ophthalmic Solution | Change From Baseline in Fluorescein Staining in the Total Eye Sum - Both Eyes Together | 0.16 units on a scale | Standard Deviation 2.075 |
p-value: 0.0394t-test, 2 sided
Post Hoc
Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve
Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort. Area under the curve is presented. AUC at each visit is calculated as follows: Calculate (time point - previous time point)\*0.5\*(discomfort score at time point + previous discomfort score at time point) then sum all of those values together. Given that this was taken every 5 minutes from 0 to 90 minutes, the maximum value for AUC would then be (5\*0.5\*8)\*18=360, and the minimum value would be (5\*0.5\*0)\*18=0. Given this, the minimum and maximum change from baseline would be -360 to 360.
Time frame: Baseline, Visit 5 (Day 7), Visit 6 (Day 14), and Visit 7 (Day 28)
Population: Analysis was done on ITT population with Observed Data Only. The number analyzed in one or more rows differs from overall number analyzed because the number of participants/study eye analyzed can vary with each visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 6 (Day 14), 5 Minutes | 0.13 Score on a scale*min | Standard Error 0.542 |
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 7 (Day 28), 90 Minutes | -17.64 Score on a scale*min | Standard Error 8.266 |
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 6 (Day 14), 90 Minutes | -9.32 Score on a scale*min | Standard Error 6.621 |
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 6 (Day 14), 45 Minutes | -8.15 Score on a scale*min | Standard Error 3.727 |
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 5 (Day 7), 5 Minutes | -0.76 Score on a scale*min | Standard Error 0.511 |
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 7 (Day 28), 45 Minutes | -8.58 Score on a scale*min | Standard Error 4.676 |
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 5 (Day 7), 90 Minutes | -9.82 Score on a scale*min | Standard Error 6.57 |
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 5 (Day 7), 45 Minutes | -6.98 Score on a scale*min | Standard Error 3.791 |
| Low Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 7 (Day 28), 5 Minutes | -0.28 Score on a scale*min | Standard Error 0.576 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 6 (Day 14), 45 Minutes | -16.46 Score on a scale*min | Standard Error 3.729 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 5 (Day 7), 5 Minutes | -1.05 Score on a scale*min | Standard Error 0.501 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 5 (Day 7), 45 Minutes | -13.10 Score on a scale*min | Standard Error 3.713 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 5 (Day 7), 90 Minutes | -17.43 Score on a scale*min | Standard Error 6.43 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 6 (Day 14), 5 Minutes | -1.54 Score on a scale*min | Standard Error 0.542 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 6 (Day 14), 90 Minutes | -22.34 Score on a scale*min | Standard Error 6.619 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 7 (Day 28), 5 Minutes | -1.49 Score on a scale*min | Standard Error 0.565 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 7 (Day 28), 45 Minutes | -19.27 Score on a scale*min | Standard Error 4.578 |
| High Dose ST-100 Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 7 (Day 28), 90 Minutes | -32.20 Score on a scale*min | Standard Error 8.085 |
| Placebo Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 5 (Day 7), 90 Minutes | -5.70 Score on a scale*min | Standard Error 6.487 |
| Placebo Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 5 (Day 7), 5 Minutes | -0.18 Score on a scale*min | Standard Error 0.506 |
| Placebo Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 7 (Day 28), 5 Minutes | -0.77 Score on a scale*min | Standard Error 0.576 |
| Placebo Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 5 (Day 7), 45 Minutes | -5.39 Score on a scale*min | Standard Error 3.743 |
| Placebo Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 7 (Day 28), 90 Minutes | -21.48 Score on a scale*min | Standard Error 8.238 |
| Placebo Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 6 (Day 14), 45 Minutes | -9.36 Score on a scale*min | Standard Error 3.683 |
| Placebo Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 6 (Day 14), 5 Minutes | -0.30 Score on a scale*min | Standard Error 0.537 |
| Placebo Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 7 (Day 28), 45 Minutes | -11.18 Score on a scale*min | Standard Error 4.661 |
| Placebo Ophthalmic Solution | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Change from Baseline to Visit 6 (Day 14), 90 Minutes | -16.89 Score on a scale*min | Standard Error 6.539 |