Safety and Efficacy of KPI-121 in Subjects With DED



Status:Recruiting
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:July 10, 2018
End Date:September 2019
Contact:Mary Bearkland
Email:CT006@kalarx.com
Phone:781-996-5252

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A Phase 3, Double-masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle In Subjects With Dry Eye Disease (STRIDE 3)

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 14 days, with 1-2
drops instilled in each eye four times daily (QID).

This is a Phase 3, 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 in subjects with dry eye disease.

Inclusion Criteria:

- Have a documented clinical diagnosis of dry eye disease in both eyes

Exclusion Criteria:

- Known hypersensitivity or contraindication to the investigational 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; or have
been exposed to an investigational drug within 30 days prior to screening.

- In the opinion of the 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
55
sites
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Layton, UT
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Asheville, NC
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Cranberry Township, PA
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Durham, NC
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El Paso, TX
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High Point, NC
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Hoffman Estates, Illinois 60194
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Hoffman Estates, IL
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Houston, TX
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Indianapolis, IN
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Inglewood, CA
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League City, TX
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Louisville, KY
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Mason, OH
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Memphis, TN
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Mission Hills, California 91345
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Morrow, GA
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New Albany, IN
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Newport Beach, California 92660
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Norfolk, VA
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Phoenix, AZ
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Raleigh, NC
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Rancho Cordova, California 95670
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Rapid City, SD
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Wantagh, NY
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Westminster, CA
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Winchester, Massachusetts 01890
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Winchester, MA
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