A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye

Shire

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: Lifitegrast; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01743729

1118-DRY-300

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.

Enrollment: 720 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
• A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period
• Artificial tear use within the past 30 days

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 first visit and for the duration of the study
• 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 prohibited medications at any time during the study unless otherwise specified
• 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 first visit, and/or any other ocular surgical procedure within 12 months prior to first visit; 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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720 participants in 2 patient groups, including a placebo group

Lifitegrast

Experimental group

Description:

Lifitegrast Ophthalmic Solution (5.0%)

Treatment:

Drug: Lifitegrast

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo