Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis

A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Administration of FOV1101-00 (Cyclosporine Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Mild Ongoing Ocular Allergic Inflammation

The purpose of this study is to determine the efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis.

Inclusion Criteria:

• history of ocular allergies and a positive skin test reaction to perennial allergens within the past 24 months and a history of chronic eye irritation
• visual acuity score ≥ 0.60 (EDTS)
• negative urine pregnancy test for female patients, and use of adequate birth control throughout the study period.

Exclusion Criteria:

• active ocular infection; preauricular lymphadenopathy or ocular condition that could affect study; glaucoma or abnormal intraocular pressure; ocular surgery within past 3 months; history of asthma, pregnancy or nursing
• contraindications or known allergies to the study drug(s)