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

Dry Eye Disease Clinical Trial

— OPUS-3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284516
• Other study ID #: SHP606-304
• Status: Completed
• Phase: Phase 3
• Start date: November 6, 2014
• Est. completion date: October 5, 2015

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 711
• Est. completion date: October 5, 2015
• Est. primary completion date: October 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Lifitegrast
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
• Placebo
Placebo to match active treatment, BID for 84 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Patient-Reported Eye Dryness Score 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).	Baseline to Day 14 and Day 42