Who is sponsoring NCT01201798?

NCT01201798 is sponsored by Alcon Research.

What condition does NCT01201798 study?

NCT01201798 studies Endogenous Anterior Uveitis.

What drugs are being tested in NCT01201798?

Interventions: Difluprednate 0.05% ophthalmic emulsion, Prednisolone acetate 1.0% ophthalmic suspension.

What is the status of NCT01201798?

NCT01201798 is currently COMPLETED.

Last reviewed 2012-10-15 · How we verify

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

NCT01201798 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Alcon Research
Phase	Phase 3
Status	COMPLETED
Enrolment	111
Start date	2010-10
Completion	2011-08

Conditions

Endogenous Anterior Uveitis

Interventions

Difluprednate 0.05% ophthalmic emulsion
Prednisolone acetate 1.0% ophthalmic suspension

Primary outcomes

Change From Baseline (Day 0) in Anterior Chamber Cell Grade at Day 14 — Baseline (Day 0), Day 14
Inflammatory cells in the anterior chamber were assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = ≤ 1 cell count; 1 = 2 to 10 cell count; 2 = 11 to 20 cell count; 3 = 21 to 50 cell count; and 4 = \> 50 cell count.

Countries

United States