Phase 2
N=150
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Dry Eye Syndromes · Keratoconjunctivitis Sicca
Bottom Line
View on ClinicalTrials.gov: NCT02188160 ↗Enrolled (actual)
150
Serious AEs
0.7%
Results posted
Jan 2021
Primary outcome: Primary: Bulbar Conjunctival Hyperemia — 1.22; 1.36 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KPI-121 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kala Pharmaceuticals, Inc.
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bulbar Conjunctival Hyperemia |
1.22; 1.36 | — |
| PRIMARY Ocular Discomfort |
58.83; 63.63 | — |
| SECONDARY Corneal Fluorescein Staining Scores |
6.15; 7.00; 5.64; 6.16 | — |
| SECONDARY Bulbar Conjunctival Hyperemia Scores |
1.36; 1.42 | — |
| SECONDARY Ocular Discomfort |
58.83; 63.63 | — |
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 28 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/contraindication to study 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; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening.
- In the opinion of 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 (NCT02188160). 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.