Dry Eye Syndromes, Keratoconjunctivitis Sicca
Conditions
Keywords
Ocular Discomfort, Pain, Corticosteroid, Hyperemia, Dry Eye
Brief summary
The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).
Detailed description
This is a Phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.
Interventions
Sponsors
Kala Pharmaceuticals, 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
* Have a documented clinical diagnosis of dry eye disease in both eyes
Exclusion criteria
* Known hypersensitivity or contraindication to the investigational product(s) or components * History of glaucoma, IOP\>21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye. * Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening. * In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) | Comparison of mean change from baseline for bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. |
| Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4 | Baseline/Visit 2 (Day 1) - Day 4 | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. |
| Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means. |
| Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary) | Baseline/Visit 2 (Day 1) - Day 3 | Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. |
| Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15) | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) | Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. |
| Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8) | Baseline/Visit 2 (Day 1) - Visit 3 (Day 8) | Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. |
| Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15) | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) | Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores in the study eye. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe. |
| Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15) | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) | Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. |
| Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8) | Baseline/Visit 2 (Day 1) - Visit 3 (Day 8) | Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. |
| Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15) | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) | Comparison of mean corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. |
| Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15) | Baseline/Visit 2 (Day 1) - Visit 4 (Day 15) | Comparison of mean nasal corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe. |
| Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1) | Baseline/Visit 2 (Day 1) - Day 1 | Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse. |
| Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8) | Baseline/Visit 2 (Day 1) - Visit 3 (Day 8) | Comparison of ocular discomfort scores between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse using 3-day mean scores. |
Countries
United States
Participant flow
Pre-assignment details
909 subjects were randomized, 4 of which were not included in any analysis population as agreed upon with the FDA. 3 individuals had participated in more than one study therefore the data for their second-participation were not included and 1 individual did not receive treatment.
Participants by arm
| Arm | Count |
|---|---|
| KPI-121 0.25% Ophthalmic Suspension Participants randomized to KPI-121 0.25% Ophthalmic Suspension | 452 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension Participants randomized to Vehicle of KPI-121 0.25% Ophthalmic Suspension | 453 |
| Total | 905 |
Baseline characteristics
| Characteristic | KPI-121 0.25% Ophthalmic Suspension | Total | Vehicle of KPI-121 0.25% Ophthalmic Suspension |
|---|---|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 14.48 | 59.2 years STANDARD_DEVIATION 14.74 | 59.3 years STANDARD_DEVIATION 15.01 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 39 Participants | 74 Participants | 35 Participants |
| Race (NIH/OMB) Black or African American | 58 Participants | 112 Participants | 54 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) White | 345 Participants | 697 Participants | 352 Participants |
| Region of Enrollment United States | 452 participants | 905 participants | 453 participants |
| Sex: Female, Male Female | 332 Participants | 686 Participants | 354 Participants |
| Sex: Female, Male Male | 120 Participants | 219 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 452 | 0 / 453 |
| other Total, other adverse events | 57 / 452 | 44 / 453 |
| serious Total, serious adverse events | 3 / 452 | 0 / 453 |
Outcome results
Primary
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
Comparison of mean change from baseline for bulbar conjunctival hyperemia in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-4 grading scale. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.
Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) | -0.3812 score on a scale | Standard Deviation 0.6056 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) | -0.2371 score on a scale | Standard Deviation 0.62256 |
Primary
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15)
Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) | -11.14 score on a scale | Standard Deviation 19.901 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) | -9.24 score on a scale | Standard Deviation 17.002 |
Secondary
Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8)
Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time frame: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8) | -9.6 score on a scale | Standard Deviation 18.66 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8) | -8.0 score on a scale | Standard Deviation 18.94 |
Secondary
Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15)
Comparison of mean eye dryness between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15) | -14.0 score on a scale | Standard Deviation 22.78 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15) | -11.5 score on a scale | Standard Deviation 20.53 |
Secondary
Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Comparison of mean corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe.
Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15) | -0.6 score on a scale | Standard Deviation 0.86 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15) | -0.5 score on a scale | Standard Deviation 0.83 |
Secondary
Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Comparison of mean nasal corneal fluorescein staining in the study eye between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using methods developed by the National Eye Institute (NEI) Dry Eye Workshop in evaluating 5 regions of the cornea (superior, inferior, nasal, temporal and central) using a 0-3 grading scale, where 0 = no visible staining, 1 = Mild, 2 = moderate and 3 = severe.
Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15) | -0.6 score on a scale | Standard Deviation 0.86 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15) | -0.4 score on a scale | Standard Deviation 0.83 |
Secondary
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15)
Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15) | -10.20 score on a scale | Standard Deviation 20.722 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15) | -8.38 score on a scale | Standard Deviation 17.974 |
Secondary
Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary)
Comparison of mean ocular discomfort severity between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time frame: Baseline/Visit 2 (Day 1) - Day 3
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary) | -3.28 score on a scale | Standard Deviation 13.697 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary) | -3.15 score on a scale | Standard Deviation 14.126 |
Secondary
Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8)
Comparison of ocular discomfort scores between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse using 3-day mean scores.
Time frame: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8) | -6.92 score on a scale | Standard Deviation 15.541 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8) | -4.86 score on a scale | Standard Deviation 14.911 |
Secondary
Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8)
Comparison of mean ocular discomfort frequency between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time frame: Baseline/Visit 2 (Day 1) - Visit 3 (Day 8)
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8) | -5.96 score on a scale | Standard Deviation 16.133 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8) | -4.42 score on a scale | Standard Deviation 16.133 |
Secondary
Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4
Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time frame: Baseline/Visit 2 (Day 1) - Day 4
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4 | -5.09 score on a scale | Standard Deviation 14.523 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4 | -4.10 score on a scale | Standard Deviation 14.894 |
Secondary
Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup
Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse, in a sub-group of participants with more severe ocular discomfort at baseline, using 3 day means.
Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Population: Sub-group of Intent to Treat population with more severe ocular discomfort minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup | -12.45 score on a scale | Standard Deviation 20.352 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup | -9.45 score on a scale | Standard Deviation 17.489 |
Secondary
Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1)
Comparison of mean ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse.
Time frame: Baseline/Visit 2 (Day 1) - Day 1
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1) | -2.33 score on a scale | Standard Deviation 13.707 |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1) | -2.43 score on a scale | Standard Deviation 13.364 |
Secondary
Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15)
Proportion of subjects with ≥1 improvement from baseline in conjunctival hyperemia scores in the study eye. The grading scale was based on the Cornea and Contact Lens Research Unit Grading Scale where 0 = none, 1 = very slight, 2 = slight, 3 = moderate and 4 = severe.
Time frame: Baseline/Visit 2 (Day 1) - Visit 4 (Day 15)
Population: Intent to Treat population minus subjects in each treatment group that discontinued the study by this time point or otherwise did not have this assessment completed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KPI-121 0.25% Ophthalmic Suspension | Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15) | 171 Participants |
| Vehicle of KPI-121 0.25% Ophthalmic Suspension | Proportion of Subjects With ≥ 1 Unit Improvement From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia Worst Region at Visit 4 (Day 15) | 127 Participants |