A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease
Overview
- Phase
- Phase 3
- Intervention
- Vehicle of KPI-121 0.25% Ophthalmic Suspension
- Conditions
- Dry Eye Syndromes
- Sponsor
- Kala Pharmaceuticals, Inc.
- Enrollment
- 918
- Locations
- 60
- Primary Endpoint
- Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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, Intraocular Pressure (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.
Arms & Interventions
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Intervention: Vehicle of KPI-121 0.25% Ophthalmic Suspension
KPI-121 0.25% Ophthalmic Suspension
Intervention: KPI-121 0.25% Ophthalmic Suspension
Outcomes
Primary Outcomes
Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15)
Time Frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Comparison of mean bulbar conjunctival hyperemia 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 Corneal Fluorescein Staining Score at Visit 4 (Day 15)
Time Frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
Comparison of mean corneal fluorescein staining 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 Ocular Discomfort Severity at Visit 4 (Day 15)
Time Frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
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) Ocular Discomfort Severity at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort
Time Frame: Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15)
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, in a sub-group of participants with more severe ocular discomfort at baseline.
Secondary Outcomes
- Change in Ocular Discomfort Severity Scores on Day 4 Day 4 (Diary) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort(Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8))
- Change From Baseline/Visit 2 (Day 1) in Conjunctival Hyperemia Scores With a Day 1 Conjunctival Hyperemia Score of ≥ 2 in the Subgroup of Participants With More Severe Ocular Discomfort(Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15))
- Subjects With a Grade of 0 in Conjunctival Hyperemia Score at Visit 4 (Day 15)(Visit 4 (Day 15))
- Change From Baseline/Visit 2 (Day 1) Conjunctival Hyperemia Scores at Visit 4 (Day 15) for the Mean of All Regions (Nasal, Temporal, Frontal)(Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15))
- Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus Baseline/Visit 2 (Day 1) in the Subgroup of Participants With More Severe Ocular Discomfort.(Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8))
- Change in Ocular Discomfort Severity Scores on Day 4 (Diary) Minus Baseline/Visit 2 (Day 1)(Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8))
- Proportion of Subjects With ≥1 Improvement in Conjunctival Hyperemia at Visit 4 (Day 15)(Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15))
- Change in Ocular Discomfort Severity Scores Prior to Visit 3 (Day 8) Minus the Mean of the Scores to Baseline/Visit 2 (Day 1)(Baseline/Visit 2 (Day 1) and to Visit 3 (Day 8))
- Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) in the Subgroup of Participants With More Severe Ocular Discomfort at Baseline (Day 1)(Baseline/Visit 2 (Day 1) and to Visit 4 (Day 15))