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

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

Indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns). Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary.

This investigational drug is a low dose cyclosporine (also known as cyclosporine A; CsA) formulation for topical ocular administration. FOV1101-00 is presented as a solution for topical ophthalmic administration in two strengths, concentration 1 or concentration 2 w/v cyclosporine in citrate buffered aqueous vehicle. Application is intended as four times per day.

PRED FORTE® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely.

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