Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2014
End Date:August 2016

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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

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.

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).

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.
We found this trial at
8
sites
Artesia, California 90701
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Birmingham, Alabama 35294
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Birmingham, AL
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Cleveland, Ohio 44115
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Cleveland, OH
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Kansas City, Missouri 64111
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Kansas City, MO
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Mission Hills, California
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Mission Hills, CA
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Norfolk, Virginia 23502
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Norfolk, VA
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Torrance, California 90505
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Torrance, CA
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Wantagh, New York 11793
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Wantagh, NY
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