A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
NCT ID: NCT02284516
Last Updated: 2021-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
711 participants
INTERVENTIONAL
2014-11-06
2015-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lifitegrast
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
Lifitegrast
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
Placebo
Placebo to match active treatment, BID for 84 days
Placebo
Placebo to match active treatment, BID for 84 days
Interventions
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Lifitegrast
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
Placebo
Placebo to match active treatment, BID for 84 days
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Abrams Eye Institute
Las Vegas, Nevada, United States
Clinical Vision Research Center at SUNY
New York, New York, United States
Ophthalmic Consultants Of Long Island
Rockville Centre, New York, United States
South Shore Eye Care, LLP
Wantagh, New York, United States
Abrams Eye Center
Cleveland, Ohio, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Matossian Eye Associates
Doylestown, Pennsylvania, United States
Toyos Clinic
Nashville, Tennessee, United States
The Cataract & Glaucoma Center
El Paso, Texas, United States
Advanced Laser Vision and Surgical Institute
Houston, Texas, 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
Eye Clinics of South Texas, P.A.
San Antonio, Texas, United States
R and R Eye Research, LLC.
San Antonio, Texas, United States
See Clearly Vision
McLean, Virginia, United States
Countries
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References
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Holland EJ, Jackson MA, Donnenfeld E, Piccolo R, Cohen A, Barabino S, Rolando M, Figueiredo FC. Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Moderate to Severe Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials. JAMA Ophthalmol. 2021 Nov 1;139(11):1200-1208. doi: 10.1001/jamaophthalmol.2021.3943.
Holland EJ, Luchs J, Karpecki PM, Nichols KK, Jackson MA, Sall K, Tauber J, Roy M, Raychaudhuri A, Shojaei A. Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60. doi: 10.1016/j.ophtha.2016.09.025. Epub 2016 Oct 27.
Other Identifiers
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SHP606-304
Identifier Type: -
Identifier Source: org_study_id
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