Safety Study of Lifitegrast to Treat Dry Eye

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.

Official Title
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A Phase 3, Multicenter, Randomized, Double-Masked and Placebo-Controlled Study Evaluating the Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (SONATA)

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: Lifitegrast
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 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 24h prior to Visit 1 and for some duration during 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 during the appropriate pre-study washout period and 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration:  1 year<br>|
| Experimental: Lifitegrast<br>Active | Drug: Lifitegrast<br>* Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration:  1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year |  | Day 0 to Day 360 |