A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.

Key facts

Study ID

NCT02284516

Run by

Shire

People needed

711

Starts

2014-11-06

Expected to finish

2015-10-05

Last updated by the study team

2021-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient-reported history of Dry Eye Disease in both eyes.
• Use of over the counter artificial tears within the past 30 days.
• A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.
• Able and willing to comply with all study procedures.

You may not qualify if…

• Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.
• Unwilling to stop wearing contact lenses during the study.
• LASIK or other ocular surgical procedures within 12 months prior to or during the study.
• Use of prohibited medications
• Significant medical conditions that could affect the study parameters.

Where it is running

• University of Alabama at Birmingham, UAB School of Optometry — Birmingham, Alabama, United States
• Arizona Eye Center — Chandler, Arizona, United States
• Sall Research Medical Center — Artesia, California, United States
• United Medical Research Institute — Inglewood, California, United States
• North Valley Eye Medical Group, Inc — Mission Hills, California, United States
• Montebello Medical Eye Center, Inc. — Montebello, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• Arch Health Partners — Poway, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Shasta Eye Medical Group, Inc. — Redding, California, United States
• West Coast Eye Care Associates — San Diego, California, United States
• Chicago Cornea Consultants, Ltd. — Hoffman Estates, Illinois, United States
• Jackson Eye, SC — Lake Villa, Illinois, United States
• Price Vision Group — Indianapolis, Indiana, United States
• John-Kenyon American Eye Institute — New Albany, Indiana, United States
• Koffler Vision Group — Lexington, Kentucky, United States
• The Eye Care Institute — Louisville, Kentucky, United States
• Holpro Vision, Ltd. — Union, Kentucky, United States
• Clinical Eye Research of Boston — Winchester, Massachusetts, United States
• Lifelong Vision Foundation — Chesterfield, Missouri, United States
• Tauber Eye Center — Kansas City, Missouri, United States
• Tekwani Vision Center — St Louis, Missouri, United States
• Ophthalmology Consultants, Ltd. — St Louis, Missouri, United States
• Comprehensive Eye Care, Ltd. — Washington, Missouri, United States
• Wellish Vision Institute — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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