Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease
This trial has been completed.
|Sponsor||Kala Pharmaceuticals, Inc.|
|Start date||July 2014|
|End date||December 2015|
|Trial size||206 participants|
|Trial identifier||NCT02218489, KPI-121-C-003|
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 gland disease.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Birmingham, AL||UAB School of Optometry||completed|
|Artesia, CA||Sall Research Medical Center||completed|
|Mission Hills, CA||North Valley Eye Medical Group||completed|
|Torrance, CA||Wolstan & Goldberg Eye Associates||completed|
|Kansas City, MO||Tauber Eye Center||completed|
|Wantagh, NY||South Shore Eye Center, LLP||completed|
|Cleveland, OH||Abrams Eye Center||completed|
|Norfolk, VA||Virginia Eye Consultants||completed|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Posterior Lid Margin Hyperemia
time frame: Day 29
time frame: Day 22 to Day 29
Male or female participants at least 18 years old.
Inclusion Criteria: Have a documented clinical diagnosis of inflammatory meibeomian gland disease in both eyes. Exclusion Criteria: - Known hypersensitivity/contraindication to study product(s) or components. - Be currently receiving treatment for glaucoma, have history of or current glaucoma, or an IOP 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.
|Official title||A Phase II, Double-Masked, Randomized, Vehicle-Controlled Study to Evaluate the Effect of KPI-121 0.25% Ophthalmic Suspension on Signs and Symptoms of Inflammatory Meibomian Gland Disease|
|Principal investigator||Marc Abrams, MD|
|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 subjects with signs and symptoms of inflammatory meibomian gland disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).|
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