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
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Newport Beach, California 92660
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Hoffman Estates, Illinois 60194
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Houston, TX
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Mission Hills, California 91345
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Rancho Cordova, California 95670
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Winchester, Massachusetts 01890
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