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

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ClinicalTrials.gov Identifier: NCT01743729
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Shire

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 Drug: Lifitegrast Drug: Placebo Phase 3

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)
Study Start Date : December 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lifitegrast

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%




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.



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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)

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


  Show 31 Study Locations
Sponsors and Collaborators
Shire
Investigators
Study Director: Charles Semba, MD SARcode Bioscience

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01743729     History of Changes
Other Study ID Numbers: 1118-DRY-300
First Posted: December 6, 2012    Key Record Dates
Results First Posted: February 24, 2017
Last Update Posted: February 24, 2017
Last Verified: January 2017

Keywords provided by Shire:
SAR 1118

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Lifitegrast
Pharmaceutical Solutions
Ophthalmic Solutions