A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
- Registration Number
- NCT02284516
- Lead Sponsor
- Shire
- Brief Summary
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 711
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo to match active treatment, BID for 84 days Lifitegrast Lifitegrast Lifitegrast Ophthalmic Solution 5%, BID for 84 days
- Primary Outcome Measures
Name Time Method Change From Baseline in Patient-Reported Eye Dryness Score to Day 84 Baseline to Day 84 Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
- Secondary Outcome Measures
Name Time Method Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42 Baseline to Day 14 and Day 42 Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Related Research Topics
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Trial Locations
- Locations (41)
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
Scroll for more (31 remaining)University of Alabama at Birmingham, UAB School of Optometry🇺🇸Birmingham, Alabama, United States