CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 111 enrolled
Drug / intervention
Difluprednate 0.05% ophthalmic emulsion +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01201798
NCT01201798Phase 3Completed

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

Alcon Research·interventional·Posted Sep 15, 2010·Updated Nov 15, 2012

In Brief

A Phase 3 clinical trial evaluating Difluprednate 0.05% ophthalmic emulsion and Prednisolone acetate 1.0% ophthalmic suspension for Endogenous Anterior Uveitis. Completed, enrolled 111 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 15, 2010
Enrollment StartOct 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.8 years ago

Interventions

Difluprednate 0.05% ophthalmic emulsiondrug

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

Prednisolone acetate 1.0% ophthalmic suspensiondrug

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