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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01743729
First Posted: December 6, 2012
Last Update Posted: February 24, 2017
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.
Information provided by (Responsible Party):
Shire
December 3, 2012
December 6, 2012
August 9, 2016
February 24, 2017
February 24, 2017
December 2012
October 2013   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • Corneal staining score [ Time Frame: Week 12 ]
  • Patient-reported dryness score [ Time Frame: Week 12 ]
  • Safety and tolerability of lifitegrast Ophthalmic Solution (5.0%) compared to placebo, including incidence and severity of ocular and non-ocular adverse events [ Time Frame: Week 12 ]
Complete list of historical versions of study NCT01743729 on ClinicalTrials.gov Archive Site
Not Provided
  • Corneal fluorescein score [ Time Frame: Week 12 ]
  • Conjunctival lissamine staining [ Time Frame: Week 12 ]
  • Eye discomfort scores [ Time Frame: Week 12 ]
Not Provided
Not Provided
 
A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye
  • Drug: Lifitegrast
    Lifitegrast Ophthalmic Solution 5.0%
    Other Name: SAR 1118
  • Drug: Placebo
    Placebo for Lifitegrast Ophthalmic Solution 5.0%
  • Experimental: Lifitegrast
    Lifitegrast Ophthalmic Solution (5.0%)
    Intervention: Drug: Lifitegrast
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
720
October 2013
October 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01743729
1118-DRY-300
No
Not Provided
Not Provided
Shire
Shire
Not Provided
Study Director: Charles Semba, MD SARcode Bioscience
Shire
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP