A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)
OPUS-3
A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use
1 other identifier
interventional
711
1 country
41
Brief Summary
Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2014
Shorter than P25 for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
November 6, 2014
CompletedStudy Start
First participant enrolled
November 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2015
CompletedResults Posted
Study results publicly available
March 15, 2017
CompletedJune 11, 2021
June 1, 2021
11 months
October 30, 2014
September 30, 2016
June 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).
Baseline to Day 84
Secondary Outcomes (1)
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
Baseline to Day 14 and Day 42
Study Arms (2)
Lifitegrast
EXPERIMENTALLifitegrast Ophthalmic Solution 5%, BID for 84 days
Placebo
PLACEBO COMPARATORPlacebo to match active treatment, BID for 84 days
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (41)
University of Alabama at Birmingham, UAB School of Optometry
Birmingham, Alabama, 35294, United States
Arizona Eye Center
Chandler, Arizona, 85225, United States
Sall Research Medical Center
Artesia, California, 90701, United States
United Medical Research Institute
Inglewood, California, 90301, United States
North Valley Eye Medical Group, Inc
Mission Hills, California, 91345, United States
Montebello Medical Eye Center, Inc.
Montebello, California, 90640, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
Arch Health Partners
Poway, California, 92064, United States
Martel Eye Medical Group
Rancho Cordova, California, 95670, United States
Shasta Eye Medical Group, Inc.
Redding, California, 96001, United States
West Coast Eye Care Associates
San Diego, California, 92115, United States
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, 60169, United States
Jackson Eye, SC
Lake Villa, Illinois, 60046, United States
Price Vision Group
Indianapolis, Indiana, 46260, United States
John-Kenyon American Eye Institute
New Albany, Indiana, 47150, United States
Koffler Vision Group
Lexington, Kentucky, 40509, United States
The Eye Care Institute
Louisville, Kentucky, 40206, United States
Holpro Vision, Ltd.
Union, Kentucky, 41091, United States
Clinical Eye Research of Boston
Winchester, Massachusetts, 01890, United States
Lifelong Vision Foundation
Chesterfield, Missouri, 63017, United States
Tauber Eye Center
Kansas City, Missouri, 64111, United States
Tekwani Vision Center
St Louis, Missouri, 63128, United States
Ophthalmology Consultants, Ltd.
St Louis, Missouri, 63131, United States
Comprehensive Eye Care, Ltd.
Washington, Missouri, 63090, United States
Wellish Vision Institute
Las Vegas, Nevada, 89119, United States
Abrams Eye Institute
Las Vegas, Nevada, 89148, United States
Clinical Vision Research Center at SUNY
New York, New York, 10036, United States
Ophthalmic Consultants Of Long Island
Rockville Centre, New York, 11570, United States
South Shore Eye Care, LLP
Wantagh, New York, 11793, United States
Abrams Eye Center
Cleveland, Ohio, 44115, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066, United States
Matossian Eye Associates
Doylestown, Pennsylvania, 18902, United States
Toyos Clinic
Nashville, Tennessee, 37203, United States
The Cataract & Glaucoma Center
El Paso, Texas, 79902, United States
Advanced Laser Vision and Surgical Institute
Houston, Texas, 77034, United States
Whitsett Vision Group
Houston, Texas, 77056, United States
University of Houston College of Optometry
Houston, Texas, 77204, United States
The Eye Clinic of Texas (Houston Eye Associates)
League City, Texas, 77573, United States
Eye Clinics of South Texas, P.A.
San Antonio, Texas, 78209, United States
R and R Eye Research, LLC.
San Antonio, Texas, 78229, United States
See Clearly Vision
McLean, Virginia, 22012, United States
Related Publications (2)
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.
PMID: 34617974DERIVEDHolland 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.
PMID: 28079022DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire (Note: Lifitegrast was divested to Novartis in 2019)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2014
First Posted
November 6, 2014
Study Start
November 6, 2014
Primary Completion
October 5, 2015
Study Completion
October 5, 2015
Last Updated
June 11, 2021
Results First Posted
March 15, 2017
Record last verified: 2021-06