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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01743729
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : February 24, 2017
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Lifitegrast Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : December 7, 2012
Actual Primary Completion Date : October 1, 2013
Actual Study Completion Date : October 1, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lifitegrast

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lifitegrast
Lifitegrast Ophthalmic Solution (5.0%)
 Drug: Lifitegrast
Lifitegrast Ophthalmic Solution 5.0%
Other Name: SAR 1118
Placebo Comparator: Placebo Drug: Placebo
Placebo for Lifitegrast Ophthalmic Solution 5.0%


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743729


Locations
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United States, California
OPUS-2 Investigational Site
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
United States, Connecticut
OPUS-2 Investigational Site
Danbury, Connecticut, United States, 06810
United States, Florida
OPUS-2 Investigational Site
Fort Myers, Florida, United States, 33901
United States, Illinois
OPUS-2 Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, Indiana
OPUS-2 Investigational Site
Indianapolis, Indiana, United States, 46260
OPUS-2 Investigational Site
New Albany, Indiana, United States, 47150
United States, Kentucky
OPUS-2 Investigational Site
Lexington, Kentucky, United States, 40509
United States, Minnesota
OPUS-2 Investigational Site
Saint Paul, Minnesota, United States, 55082
United States, Missouri
OPUS-2 Investigational Site
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
United States, New York
OPUS-2 Investigational Site
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
United States, Ohio
OPUS-2 Investigational Site
Cleveland, Ohio, United States, 44115
United States, Pennsylvania
OPUS-2 Investigational Site
Philadelphia, Pennsylvania, United States, 19148
United States, Texas
OPUS-2 Investigational Site
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
United States, Virginia
OPUS-2 Investigational Site
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Takeda
More Information
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Publications of Results:

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01743729    
Other Study ID Numbers: 1118-DRY-300
First Posted: December 6, 2012    Key Record Dates
Results First Posted: February 24, 2017
Last Update Posted: June 23, 2021
Last Verified: June 2021
Keywords provided by Takeda ( Shire ):
SAR 1118
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Keratitis
Corneal Diseases
Lifitegrast
Ophthalmic Solutions
Pharmaceutical Solutions