Evaluation of Efficacy of Coadministration of FOV1101-00 and Prednisolone Acetate in Patients With Mild Ongoing Ocular Allergic Inflammation

A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mild Ongoing Ocular Allergic Inflammation

This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up to 5 sites. The purpose of this study is to determine how effective the combination of Pred Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the prevention of eye allergies. Study subjects will be randomized to one of the following:

• FOV1101-00 concentration 1 and Pred Mild®
• FOV1101-00 concentration 2 and Pred Mild®
• Vehicle of FOV1101-00 and Pred Forte®
• Vehicle of FOV1101-00 and Vehicle of FOV1101-00

Inclusion Criteria:

• history of ocular allergies and a positive skin test reaction to allergens within the past 24 months and a history of chronic eye irritation;

Exclusion Criteria:

• active ocular infection; clinically significant blepharitis; follicular conjunctivitis; iritis; any type of glaucoma; ocular surgery within past 3 months; pregnancy or nursing