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

Shire

Status and phase

Completed

Phase 3

Conditions

Dry Eye Disease

Keratoconjunctivitis Sicca

Treatments

Drug: Lifitegrast

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01421498

1118-KCS-200

Details and patient eligibility

About

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.

Enrollment

588 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)