Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Lifitegrast; Placebo
Intervention description: Ophthalmic Solution; Ophthalmic Solution
Intervention MeSH terms: Lifitegrast
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether SAR 1118 at three different concentrations,
      compared to placebo, is effective in the prevention of the signs and symptoms of allergic
      conjunctivitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent form and HIPAA document

          -  Willing and able to comply with all study procedures

          -  Be at least 18 years of age at the time of enrollment

          -  20/40 vision, or better, in each eye

          -  History of ocular allergies, and a positive skin and ocular allergic reaction to
             allergens

          -  A negative urine pregnancy test if female of childbearing potential and must use
             adequate birth control throughout the study period

        Exclusion Criteria:

          -  Preauricular lymphadenopathy or any ocular condition that could affect study
             parameters (particularly, glaucoma, diabetic retinopathy, clinically significant
             blepharitis, follicular conjunctivitis and iritis)

          -  Have had any ocular infection within the last 30 days

          -  A positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use
             of artificial tears)

          -  Any significant illness that could be expected to interfere with study parameters

          -  Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye

          -  Use of any investigational product or device within one month prior to Visit 1 or
             during the study period

          -  Concomitant use of any prohibited medication (antihistamines, corticosteroids, all
             ocular medications or anti-allergic therapies) during the trial or within the washout
             period

          -  Any blood donation or significant loss of blood within 56 days of Visit 1

          -  Any history of autoimmune disease, immunodeficiency disorder, positive HIV, hepatitis
             B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow
             transplant. Any known history of iritis/uveitis, glaucoma, or other chronic
             ophthalmologic disorder other than allergic conjunctivitis

          -  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 3 months prior to Visit 1

          -  Known history of alcohol abuse and/or drug abuse