Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)

Overview

The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.

Full Title of Study: “A Phase 3, Multicenter, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy of a 5.0% Concentration of SAR 1118 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (OPUS-1)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 28, 2012

Interventions

  • Drug: Lifitegrast
    • Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks
  • Drug: Placebo
    • Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks

Arms, Groups and Cohorts

  • Experimental: 5.0% Lifitegrast
    • Lifitegrast
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84
    • Time Frame: Baseline (Day 0) 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 staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. 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/none; 1=occasional/trace; 2=countable/mild; 3=uncountable, but not confluent/moderate; 4=confluent/severe) with 0.5 point increments, and lower score indicates a better outcome. 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.
  • Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84
    • Time Frame: Baseline (Day 0) to Day 84
    • The symptom functional scale is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the symptom functional scale questionnaire were graded on a scale of 0 (none of the time) to 4 (all of the time). The index consisted of 3 sub scales: symptoms (sensitivity to light, gritty sensation, pain, blurred vision, and poor vision [Items 1-5]), visual-related sub scale of the symptom functional scale (ability to read, drive at night, use a computer, watch television [Items 6-9]), and environmental triggers (windy conditions, low humidity, air conditioning [Items 10-12]). The symptom functional scale was scored on a scale of 0 to 100, with higher scores representing greater disability. Negative change from baseline indicates improvement.

Participating in This Clinical Trial

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 – Demonstrate a positive response when exposed to the Controlled Adverse Environment model – A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period 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 and for duration of the study period – 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 topical ophthalmic preparations (including artificial tear substitutes) 72 hrs prior to Visit 1 and during the study – Any significant chronic 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 Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; 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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shire
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Study Director, Study Director, Takeda

Citations Reporting on Results

Sheppard JD, Torkildsen GL, Lonsdale JD, D'Ambrosio FA Jr, McLaurin EB, Eiferman RA, Kennedy KS, Semba CP; OPUS-1 Study Group. Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 phase 3 study. Ophthalmology. 2014 Feb;121(2):475-83. doi: 10.1016/j.ophtha.2013.09.015. Epub 2013 Nov 26.

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