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

• Corneal staining score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Patient-reported dryness score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Safety and tolerability of lifitegrast Ophthalmic Solution (5.0%) compared to placebo, including incidence and severity of ocular and non-ocular adverse events [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

• Corneal fluorescein score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Conjunctival lissamine staining [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
• Eye discomfort scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

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.

• Drug: Lifitegrast
  Lifitegrast Ophthalmic Solution 5.0%
  Other Name: SAR 1118
• Drug: Placebo
  Placebo for Lifitegrast Ophthalmic Solution 5.0%

• Experimental: Lifitegrast
  Lifitegrast Ophthalmic Solution (5.0%)
  Intervention: Drug: Lifitegrast
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

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)