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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Keratoconjunctivitis Sicca, Dry Eye Disease

Intervention / Treatment
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* Drug: Lifitegrast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5.0% Lifitegrast<br>Lifitegrast | Drug: Lifitegrast<br>* Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks<br>* Other names: SAR 1118;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining 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. | Baseline (Day 0) to Day 84 | 
| Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score 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. | Baseline (Day 0) to Day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ophthalmic delivery, Dry Eye