A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)

Phase 2

Completed

Brief Summary: The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.

Recruitment & Eligibility

Inclusion Criteria

Signed Informed Consent Form and HIPAA document
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 tear substitutes) 72 hrs prior to screening assessments and through the entire study period
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 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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Ophthalmic Solution
0.1% Lifitegrast	Lifitegrast	Lifitegrast
1.0% Lifitegrast	Lifitegrast	Lifitegrast
5.0% Lifitegrast	Lifitegrast	Lifitegrast

Primary Outcome Measures

Name	Time	Method
Inferior Corneal Fluorescein Staining Score in Pre-Controlled Adverse Environment at Day 84	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; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) 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.

Secondary Outcome Measures

Name	Time	Method
Inferior Corneal Staining Score Change From Baseline (CFB) to Day 84	Baseline (Day 0) and 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; 1=occasional; 2=countable; 3=uncountable, but not confluent; 4=confluent) 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.

Locations (5): Mundorf Eye Center
🇺🇸
Charlotte, North Carolina, United States
The Eye Care Group
🇺🇸
Waterbury, Connecticut, United States
Central Maine Eye Care
🇺🇸
Lewiston, Maine, United States
Ora, Inc. (two locations)
🇺🇸
Andover, Massachusetts, United States
Total Eye Care, P.A.
🇺🇸
Memphis, Tennessee, United States