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

Last updated: June 2, 2021
Sponsor: Shire
Overall Status: Completed

Phase

3

Condition

Dry Eye Disease

Dry Eyes

Sjogren's Syndrome

Treatment

N/A

Clinical Study ID

NCT02284516
SHP606-304
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 birthcontrol throughout the study.
  • Able and willing to comply with all study procedures.

Exclusion

Exclusion Criteria:

  • Presence of an ocular condition that could affect the study parameters such as activeocular 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 thestudy.
  • Use of prohibited medications
  • Significant medical conditions that could affect the study parameters.

Study Design

Total Participants: 711
Study Start date:
November 06, 2014
Estimated Completion Date:
October 05, 2015

Connect with a study center

  • University of Alabama at Birmingham, UAB School of Optometry

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Arizona Eye Center

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Sall Research Medical Center

    Artesia, California 90701
    United States

    Site Not Available

  • Martel Eye Medical Group

    Cordova, California 95670
    United States

    Site Not Available

  • United Medical Research Institute

    Inglewood, California 90301
    United States

    Site Not Available

  • North Valley Eye Medical Group, Inc

    Mission Hills, California 91345
    United States

    Site Not Available

  • Montebello Medical Eye Center, Inc.

    Montebello, California 90640
    United States

    Site Not Available

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

  • Arch Health Partners

    Poway, California 92064
    United States

    Site Not Available

  • Martel Eye Medical Group

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • Shasta Eye Medical Group, Inc.

    Redding, California 96001
    United States

    Site Not Available

  • West Coast Eye Care Associates

    San Diego, California 92115
    United States

    Site Not Available

  • Chicago Cornea Consultants, Ltd.

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Jackson Eye, SC

    Lake Villa, Illinois 60046
    United States

    Site Not Available

  • Price Vision Group

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • John-Kenyon American Eye Institute

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Koffler Vision Group

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • The Eye Care Institute

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Holpro Vision, Ltd.

    Union, Kentucky 41091
    United States

    Site Not Available

  • Clinical Eye Research of Boston

    Winchester, Massachusetts 01890
    United States

    Site Not Available

  • Lifelong Vision Foundation

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Tauber Eye Center

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Ophthalmology Consultants, Ltd.

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Tekwani Vision Center

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Ophthalmology Consultants, Ltd.

    St. Louis, Missouri 63131
    United States

    Site Not Available

  • Comprehensive Eye Care, Ltd.

    Washington, Missouri 63090
    United States

    Site Not Available

  • Abrams Eye Institute

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Wellish Vision Institute

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Clinical Vision Research Center at SUNY

    New York, New York 10036
    United States

    Site Not Available

  • Ophthalmic Consultants Of Long Island

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • South Shore Eye Care, LLP

    Wantagh, New York 11793
    United States

    Site Not Available

  • Abrams Eye Center

    Cleveland, Ohio 44115
    United States

    Site Not Available

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Matossian Eye Associates

    Doylestown, Pennsylvania 18902
    United States

    Site Not Available

  • Glaucoma Consultants and Center for Eye Research, PA

    Mt. Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Total Eye Care, PA

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Toyos Clinic

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • The Cataract & Glaucoma Center

    El Paso, Texas 79902
    United States

    Site Not Available

  • Advanced Laser Vision and Surgical Institute

    Houston, Texas 77034
    United States

    Site Not Available

  • University of Houston College of Optometry

    Houston, Texas 77204
    United States

    Site Not Available

  • Whitsett Vision Group

    Houston, Texas 77056
    United States

    Site Not Available

  • The Eye Clinic of Texas (Houston Eye Associates)

    League City, Texas 77573
    United States

    Site Not Available

  • Eye Clinics of South Texas, P.A.

    San Antonio, Texas 78209
    United States

    Site Not Available

  • R and R Eye Research, LLC.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • See Clearly Vision

    McLean, Virginia 22012
    United States

    Site Not Available

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