NCT01120132

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 716 (actual)
• Sponsor: Fovea Pharmaceuticals SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Allergic Conjunctivitis

Interventions

Type	Name	Description
DRUG	CsA high dose	Solution of Cyclosporine (high dose) administered during 28 days
DRUG	CsA low dose	Solution of Cyclosporine (low dose) administered during 28 days
DRUG	PA	Suspension of Prednisolone Acetate administered during 28 days
DRUG	Placebo	Placebo solution administered during 28 days

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-05-10
• Last updated: 2012-03-09

Locations

1 site across 1 country: United States