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)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-03

Study Completion Date

2010-02-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Placebo Ophthalmic Solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Ophthalmic Solution

0.1% Lifitegrast

Lifitegrast

Group Type EXPERIMENTAL

Lifitegrast

Intervention Type DRUG

Ophthalmic Solution

1.0% Lifitegrast

Lifitegrast

Group Type EXPERIMENTAL

Lifitegrast

Intervention Type DRUG

Ophthalmic Solution

5.0% Lifitegrast

Lifitegrast

Group Type EXPERIMENTAL

Lifitegrast

Intervention Type DRUG

Ophthalmic Solution

Interventions

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Lifitegrast

Ophthalmic Solution

Intervention Type DRUG

Placebo

Ophthalmic Solution

Intervention Type DRUG

Other Intervention Names

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SAR 1118

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No