Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
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|ClinicalTrials.gov Identifier: NCT00405496|
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : November 30, 2006
|Condition or disease||Intervention/treatment||Phase|
|Anterior Uveitis||Drug: Difluprednate Ophthalmic Emulsion||Phase 2|
The primary objective was to investigate the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its clinical usefulness for treatment of this disease in the early phase of development, in comparison with Rinderon® solution (containing 0.1% betamethasone sodium phosphate) that has widely been used for treatment of postoperative inflammation, uveitis, etc. as a steroid ophthalmic solution.
The secondary objective was to establish the evaluation system for a dose-finding study.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase 2a Study of 0.05% Difluprednate Ophthalmic Emulsion in the Treatment of Anterior Uveitis (Inluding Iritis, Cyclitis, Iridocyclitis, and Panuveitis).|
|Study Start Date :||March 2000|
|Study Completion Date :||April 2001|
- The anterior chamber cell score was compared between baseline and after completion of the
- study treatment (14 +/- 2 days). The efficacy was evaluated with a 4-point scale based on the
- reduction of anterior chamber cell.
- The overall efficacy was evaluated with a 4-point-scale based on the change in the flare value
- (baseline/after completion of the study treatment ratio), as measured with a laser flare cell
- meter, and those in anterior chamber flare as measured with a slitlamp microscope and clinical
- signs and symptoms after completion of the study treatment (142 days) from baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405496
|Study Chair:||Kanjiro Masudo||Director, Kanto Rosai Hospital|