Phase 3
N=901
Safety and Efficacy of KPI-121 in Subjects With DED
Kerato Conjunctivitis Sicca
Bottom Line
View on ClinicalTrials.gov: NCT03616899 ↗Enrolled (actual)
901
Serious AEs
0.4%
Results posted
Apr 2021
Primary outcome: Primary: Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) — -13.58; -8.91 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- KPI-121 Ophthalmic Suspension (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kala Pharmaceuticals, Inc.
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) |
-13.58; -8.91 | — |
| PRIMARY 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 |
-15.59; -10.15 | — |
| SECONDARY Change From Baseline/Visit 2 (Day 1) in Bulbar Conjunctival Hyperemia at Visit 4 (Day 15) |
-0.35; -0.18 | — |
| SECONDARY Change in Conjunctival Hyperemia Scores at Visit 4 (Day 15) by Alternate Assessor |
-0.61; -0.48 | — |
| SECONDARY Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 3 (Day 8) |
-8.05; -5.83 | — |
| SECONDARY Change From Baseline/Visit 2 (Day 1) in Corneal Fluorescein Staining Score at Visit 4 (Day 15) |
-0.53; -0.43 | — |
| SECONDARY Change From Baseline/Visit 2 (Day 1) in Ocular Discomfort Severity at Visit 4 (Day 15) Using 7 Day Mean |
-11.76; -7.91 | — |
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 (NCT03616899). 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.