Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis

Shire

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: Lifitegrast; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00882687

1118-ACJ-100

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups, including a placebo group

0.1% Lifitegrast

Experimental group

Treatment:

Drug: Lifitegrast

1.0% Lifitegrast

Experimental group

Treatment:

Drug: Lifitegrast

5.0% Lifitegrast

Experimental group

Treatment:

Drug: Lifitegrast

Placebo

Placebo Comparator group

Treatment:

Other: Placebo