Status:
COMPLETED
Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease
Lead Sponsor:
Kala Pharmaceuticals, Inc.
Conditions:
Blepharitis
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 ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of inflammatory meibomian g...
Detailed Description
This is a Phase II, multicenter, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 ophthalmic suspension versus vehicle in sub...
Eligibility Criteria
Inclusion
- Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.
Exclusion
- Known hypersensitivity/contraindication to study product(s) or components.
- Be currently receiving treatment for glaucoma, have history of or current glaucoma, or an IOP (intraocular pressure) over 21mmHg at Visit 1 (Screening) or Visit 2 (Randomization).
- Be unwilling to discontinue warm compress therapy, lid expression, or lid massage 14 days prior to Day 1 and for the duration of the study.
- 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.
- Have had ocular surgery in the past 90 days or require ocular surgery during the study.
- 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 :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT02218489
Start Date
July 1 2014
End Date
June 1 2016
Last Update
January 11 2021
Active Locations (8)
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1
UAB School of Optometry
Birmingham, Alabama, United States, 35294-0010
2
Sall Research Medical Center
Artesia, California, United States, 90701
3
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
4
Wolstan & Goldberg Eye Associates
Torrance, California, United States, 90505