Status:
COMPLETED
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Lead Sponsor:
Kala Pharmaceuticals, Inc.
Conditions:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 d...
Detailed Description
This is a Phase II, 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...
Eligibility Criteria
Inclusion
- • Have a documented clinical diagnosis of dry eye disease in both eyes
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02188160
Start Date
June 1 2014
End Date
March 1 2015
Last Update
January 6 2021
Active Locations (11)
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1
Sall Research Medical Center
Artesia, California, United States, 90701
2
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
3
Martel Eye Medical Group
Rancho Cordova, California, United States, 95670
4
Eye Center of Southern CT, P.C.
Hamden, Connecticut, United States, 06518