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).
Trial Locations
- Locations (41)
Chicago Cornea Consultants, Ltd.
🇺🇸Hoffman Estates, Illinois, United States
Jackson Eye, SC
🇺🇸Lake Villa, Illinois, United States
Lifelong Vision Foundation
🇺🇸Chesterfield, Missouri, United States
Abrams Eye Center
🇺🇸Cleveland, Ohio, United States
Scott & Christie and Associates, PC
🇺🇸Cranberry Township, Pennsylvania, United States
Tauber Eye Center
🇺🇸Kansas City, Missouri, United States
South Shore Eye Care, LLP
🇺🇸Wantagh, New York, United States
Whitsett Vision Group
🇺🇸Houston, Texas, United States
University of Houston College of Optometry
🇺🇸Houston, Texas, United States
The Eye Clinic of Texas (Houston Eye Associates)
🇺🇸League City, Texas, United States
Ophthalmic Consultants Of Long Island
🇺🇸Rockville Centre, New York, United States
North Valley Eye Medical Group, Inc
🇺🇸Mission Hills, California, United States
Arizona Eye Center
🇺🇸Chandler, Arizona, United States
Sall Research Medical Center
🇺🇸Artesia, California, United States
University of Alabama at Birmingham, UAB School of Optometry
🇺🇸Birmingham, Alabama, United States
United Medical Research Institute
🇺🇸Inglewood, 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
Shasta Eye Medical Group, Inc.
🇺🇸Redding, California, United States
Martel Eye Medical Group
🇺🇸Rancho Cordova, California, United States
Clinical Eye Research of Boston
🇺🇸Winchester, Massachusetts, United States
John-Kenyon American Eye Institute
🇺🇸New Albany, Indiana, United States
Holpro Vision, Ltd.
🇺🇸Union, Kentucky, United States
Tekwani Vision Center
🇺🇸Saint Louis, Missouri, United States
Clinical Vision Research Center at SUNY
🇺🇸New York, New York, United States
Abrams Eye Institute
🇺🇸Las Vegas, Nevada, United States
Matossian Eye Associates
🇺🇸Doylestown, Pennsylvania, United States
The Cataract & Glaucoma Center
🇺🇸El Paso, Texas, United States
Eye Clinics of South Texas, P.A.
🇺🇸San Antonio, Texas, United States
Advanced Laser Vision and Surgical Institute
🇺🇸Houston, Texas, United States
Toyos Clinic
🇺🇸Nashville, Tennessee, United States
West Coast Eye Care Associates
🇺🇸San Diego, California, United States
Comprehensive Eye Care, Ltd.
🇺🇸Washington, Missouri, United States
Ophthalmology Consultants, Ltd.
🇺🇸Saint Louis, Missouri, United States
Price Vision Group
🇺🇸Indianapolis, Indiana, United States
Koffler Vision Group
🇺🇸Lexington, Kentucky, United States
The Eye Care Institute
🇺🇸Louisville, Kentucky, United States
Wellish Vision Institute
🇺🇸Las Vegas, Nevada, United States
R and R Eye Research, LLC.
🇺🇸San Antonio, Texas, United States
See Clearly Vision
🇺🇸McLean, Virginia, United States