A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye

June 2, 2021 updated by: Shire

A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Currently Using Artificial Tears (OPUS-2)

The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

720

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
    • California
      • Artesia, California, United States, 90701
        • OPUS-2 Investigational Site
      • Hemet, California, United States, 92545
        • OPUS-2 Investigational Site
      • Lancaster, California, United States, 93534
        • OPUS-2 Investigational Site
      • Mission Hills, California, United States, 91345
        • OPUS-2 Investigational Site
      • Montebello, California, United States, 90640
        • OPUS-2 Investigational Site
      • Newport Beach, California, United States, 92663
        • OPUS-2 Investigational Site
      • Petaluma, California, United States, 94954
        • OPUS-2 Investigational Site
      • Rancho Cordova, California, United States, 95670
        • OPUS-2 Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • OPUS-2 Investigational Site
    • Florida
      • Fort Myers, Florida, United States, 33901
        • OPUS-2 Investigational Site
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • OPUS-2 Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • OPUS-2 Investigational Site
      • New Albany, Indiana, United States, 47150
        • OPUS-2 Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • OPUS-2 Investigational Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55082
        • OPUS-2 Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • OPUS-2 Investigational Site
      • Des Peres, Missouri, United States, 63131
        • OPUS-2 Investigational Site
      • Independence, Missouri, United States, 64055
        • OPUS-2 Investigational Site
      • Kansas City, Missouri, United States, 64111
        • OPUS-2 Investigational Site
      • Washington, Missouri, United States, 63090
        • OPUS-2 Investigational Site
    • New York
      • New York, New York, United States, 10016
        • OPUS-2 Investigational Site
      • New York, New York, United States, 10036
        • OPUS-2 Investigational Site
      • Wantagh, New York, United States, 11793
        • OPUS-2 Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44115
        • OPUS-2 Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19148
        • OPUS-2 Investigational Site
    • Texas
      • Houston, Texas, United States, 77034
        • OPUS-2 Investigational Site
      • Houston, Texas, United States, 77055
        • OPUS-2 Investigational Site
      • League City, Texas, United States, 77573
        • OPUS-2 Investigational Site
      • San Antonio, Texas, United States, 78209
        • OPUS-2 Investigational Site
      • San Antonio, Texas, United States, 78229
        • OPUS-2 Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • OPUS-2 Investigational Site

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:

  • Willing and able to read, sign and date the informed consent and HIPAA documents
  • Willing and able to comply with all study procedures
  • Be at least 18 years of age
  • Patient-reported history of dry eye in both eyes
  • A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
  • Artificial tear use within the past 30 days

Exclusion Criteria:

  • Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy
  • Unwilling to avoid wearing contact lenses for 7 days prior to first visit and for the duration of the study
  • Any blood donation or significant loss of blood within 56 days of Visit 1
  • Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.
  • Use of any prohibited medications at any time during the study unless otherwise specified
  • Any significant illness that could interfere with study parameters
  • History of laser assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to first visit, and/or any other ocular surgical procedure within 12 months prior to first visit; or any scheduled ocular surgical procedure during the study period.
  • Known history of alcohol and/or drug abuse
  • Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo for Lifitegrast Ophthalmic Solution 5.0%
EXPERIMENTAL: Lifitegrast
Lifitegrast Ophthalmic Solution (5.0%)
Drug: Lifitegrast
Lifitegrast Ophthalmic Solution 5.0%
Other Names:
  • SAR 1118

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84
Time Frame: Baseline to Day 84
Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Baseline to Day 84
Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84
Time Frame: Baseline to Day 84
Eye dryness score was assessed on a visual analogue scale (a 7-item [burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.
Baseline to Day 84

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)

December 7, 2012

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 4, 2012

First Posted (ESTIMATE)

December 6, 2012

Study Record Updates

Last Update Posted (ACTUAL)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1118-DRY-300

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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