Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)
Condition: Keratoconjunctivitis Sicca; Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Keratoconjunctivitis
Intervention: Lifitegrast; Placebo
Intervention description: Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks; Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks
Intervention MeSH terms: Lifitegrast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 588.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ophthalmic delivery; Dry Eye

Summary:

      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.
    

Eligibility criteria:

        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)