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

June 2, 2021 updated by: Shire

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

711

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham, UAB School of Optometry
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Arizona Eye Center
    • California
      • Artesia, California, United States, 90701
        • Sall Research Medical Center
      • Inglewood, California, United States, 90301
        • United Medical Research Institute
      • Mission Hills, California, United States, 91345
        • North Valley Eye Medical Group, Inc
      • Montebello, California, United States, 90640
        • Montebello Medical Eye Center, Inc.
      • Newport Beach, California, United States, 92663
        • Eye Research Foundation
      • Poway, California, United States, 92064
        • Arch Health Partners
      • Rancho Cordova, California, United States, 95670
        • Martel Eye Medical Group
      • Redding, California, United States, 96001
        • Shasta Eye Medical Group, Inc.
      • San Diego, California, United States, 92115
        • West Coast Eye Care Associates
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Chicago Cornea Consultants, Ltd.
      • Lake Villa, Illinois, United States, 60046
        • Jackson Eye, SC
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group
      • New Albany, Indiana, United States, 47150
        • John-Kenyon American Eye Institute
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Koffler Vision Group
      • Louisville, Kentucky, United States, 40206
        • The Eye Care Institute
      • Union, Kentucky, United States, 41091
        • Holpro Vision, Ltd.
    • Massachusetts
      • Winchester, Massachusetts, United States, 01890
        • Clinical Eye Research of Boston
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Lifelong Vision Foundation
      • Kansas City, Missouri, United States, 64111
        • Tauber Eye Center
      • Saint Louis, Missouri, United States, 63131
        • Ophthalmology Consultants, Ltd.
      • Saint Louis, Missouri, United States, 63128
        • Tekwani Vision Center
      • Washington, Missouri, United States, 63090
        • Comprehensive Eye Care, Ltd.
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Wellish Vision Institute
      • Las Vegas, Nevada, United States, 89148
        • Abrams Eye Institute
    • New York
      • New York, New York, United States, 10036
        • Clinical Vision Research Center at SUNY
      • Rockville Centre, New York, United States, 11570
        • Ophthalmic Consultants of Long Island
      • Wantagh, New York, United States, 11793
        • South Shore Eye Care, LLP
    • Ohio
      • Cleveland, Ohio, United States, 44115
        • Abrams Eye Center
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Scott & Christie and Associates, PC
      • Doylestown, Pennsylvania, United States, 18902
        • Matossian Eye Associates
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Toyos Clinic
    • Texas
      • El Paso, Texas, United States, 79902
        • The Cataract & Glaucoma Center
      • Houston, Texas, United States, 77034
        • Advanced Laser Vision and Surgical Institute
      • Houston, Texas, United States, 77204
        • University of Houston College of Optometry
      • Houston, Texas, United States, 77056
        • Whitsett Vision Group
      • League City, Texas, United States, 77573
        • The Eye Clinic of Texas (Houston Eye Associates)
      • San Antonio, Texas, United States, 78229
        • R and R Eye Research, LLC.
      • San Antonio, Texas, United States, 78209
        • Eye Clinics of South Texas, P.A.
    • Virginia
      • McLean, Virginia, United States, 22012
        • See Clearly Vision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifitegrast
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
Drug: Lifitegrast
Lifitegrast Ophthalmic Solution 5%, BID for 84 days
Placebo Comparator: Placebo
Placebo to match active treatment, BID for 84 days
Drug: Placebo
Placebo to match active treatment, BID for 84 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Patient-Reported Eye Dryness Score to Day 84
Time Frame: 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).
Baseline to Day 84

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42
Time Frame: 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).
Baseline to Day 14 and Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2014

Primary Completion (Actual)

October 5, 2015

Study Completion (Actual)

October 5, 2015

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHP606-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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