NCT01201798

Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis

A Phase 3 Multicenter, Randomized, Double-Masked Study of the Safety and Efficacy of Difluprednate 0.05% Ophthalmic Emulsion Compared to Prednisolone Acetate 1% Ophthalmic Suspension in the Treatment of Endogenous Anterior Uveitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of endogenous anterior uveitis.

Conditions

• Endogenous Anterior Uveitis

Interventions

Type	Name	Description
DRUG	Difluprednate 0.05% ophthalmic emulsion	1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment
DRUG	Prednisolone acetate 1.0% ophthalmic suspension	1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-09-15
• Last updated: 2012-11-15
• Results posted: 2012-11-15

Locations

1 site across 1 country: United States