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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
711

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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Sponsor/Collaborators

Locations

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