Phase 3
N=905
Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease
Dry Eye Syndromes · Keratoconjunctivitis Sicca
Bottom Line
View on ClinicalTrials.gov: NCT02819284 ↗Enrolled (actual)
905
Serious AEs
0.3%
Results posted
Dec 2020
Primary outcome: Primary: Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) — -0.3812; -0.2371 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- KPI-121 0.25% Ophthalmic Suspension (Drug); Vehicle of KPI-121 0.25% Ophthalmic Suspension (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kala Pharmaceuticals, Inc.
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) |
-0.3812; -0.2371 | — |
| PRIMARY Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) |
-11.14; -9.24 | — |
| 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) |
171; 127 | — |
| SECONDARY Change From Baseline/ Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Visit 3 (Day 8) |
-6.92; -4.86 | — |
| SECONDARY Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Scores to Day 4 |
-5.09; -4.10 | — |
| SECONDARY Change From Baseline/Week 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) in a Subgroup |
-12.45; -9.45 | — |
| SECONDARY Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity Scores at Day 3 (Diary) |
-3.28; -3.15 | — |
| SECONDARY Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 4 (Day 15) |
-14.0; -11.5 | — |
| SECONDARY Change From Baseline/Visit 2 (Day 1) in Eye Dryness Scores at Visit 3 (Day 8) |
-9.6; -8.0 | — |
| SECONDARY Ocular Discomfort Severity Scores on Day 2 (Diary) Minus Baseline/Visit 2 (Day 1) |
-2.33; -2.43 | — |
| SECONDARY Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Frequency Scores at Visit 4 (Day 15) |
-10.20; -8.38 | — |
| SECONDARY Change From Baseline/Visit 2 (Day 1) in Subject-rated Ocular Discomfort Frequency Scores at Visit 3 (Day 8) |
-5.96; -4.42 | — |
| SECONDARY Change From Baseline/Visit 2 (Day 1) in Inferior Corneal Fluorescein Staining Score at Visit 4 (Day 15) |
-0.6; -0.5 | — |
| SECONDARY Change From Baseline/Visit 2 (Day 1) in Nasal Corneal Fluorescein Staining Score at Visit 4 (Day 15) |
-0.6; -0.4 | — |
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).
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, 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.
Data sourced from ClinicalTrials.gov (NCT02819284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.