Overview
Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis
Status:
Completed
Completed
Trial end date:
2009-05-10
2009-05-10
Target enrollment:
0
0
Participant gender:
All
All
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 conjunctivitisPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
ShireTreatments:
Lifitegrast
Ophthalmic Solutions
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