NCT00833495

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Fovea Pharmaceuticals SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Prednisolone Acetate 0.12% (Pred Mild®)	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.
DRUG	FOV1101-00	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.
DRUG	Prednisolone Acetate 1% (Pred Forte®)	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.
DRUG	Placebo	The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2009-02-02
• Last updated: 2012-03-09

Locations

1 site across 1 country: United States