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)

Shire

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: Placebo; Drug: Lifitegrast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00926185

1118-KCS-100

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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230 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Ophthalmic Solution

Treatment:

Drug: Placebo

0.1% Lifitegrast

Experimental group

Description:

Lifitegrast

Treatment:

Drug: Lifitegrast

1.0% Lifitegrast

Experimental group

Description:

Lifitegrast

Treatment:

Drug: Lifitegrast

5.0% Lifitegrast

Experimental group

Description:

Lifitegrast

Treatment:

Drug: Lifitegrast