Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study.

Abstract

PURPOSE:

Endogenous anterior uveitis (AU), when untreated, may lead to vision loss. This study compared the safety and efficacy of difluprednate versus prednisolone acetate for the treatment of this condition.

METHODS:

This phase III, double-masked, noninferiority study randomized patients with mild to moderate endogenous AU to receive difluprednate 0.05% (n = 56) four times daily, alternating with vehicle four times daily, or prednisolone acetate 1% (n = 54) eight times daily. The 14-day treatment period was followed by a 14-day dose-tapering period and a 14-day observation period. The primary efficacy end point was change in anterior chamber cell grade (range, 0 for ≤1 cell to 4 for >50 cells) from baseline to day 14.

RESULTS:

At day 14, the mean change in anterior chamber cell grade with difluprednate was noninferior to that with prednisolone acetate (-2.2 vs. -2.0, P = 0.16). The proportions of difluprednate-treated patients versus prednisolone acetate-treated patients demonstrating complete clearing of anterior chamber cells at day 3 were 13.0% vs. 2.1% (P = 0.046) and at day 21 were 73.9% vs. 63.8% (P = 0.013). A significant between-group difference in the mean IOP increase was seen at day 3 (2.5 mm Hg for difluprednate-treated patients and 0.1 mm Hg for prednisolone acetate-treated patients, P = 0.0013) but not at other time points. The mean IOP values in both groups remained less than 21 mm Hg throughout the study.

CONCLUSIONS:

Difluprednate 0.05% four times daily is well tolerated and is noninferior to prednisolone acetate 1% eight times daily for the treatment of endogenous AU. (ClinicalTrials.gov number, NCT01201798.).

• Authors: John D Sheppard, Melissa M Toyos, John H Kempen, Paramjit Kaur, C Stephen Foster
• Journal: Investigative ophthalmology & visual science (Invest Ophthalmol Vis Sci) Vol. 55 Issue 5 Pg. 2993-3002 (May 06 2014) ISSN: 1552-5783 [Electronic] United States
• PMID: 24677110 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Glucocorticoids
• prednisolone acetate
• Fluprednisolone
• Prednisolone
• difluprednate

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Analysis of Variance
• Anterior Chamber
• Anti-Inflammatory Agents (administration & dosage)
• Child
• Double-Blind Method
• Drug Administration Schedule
• Female
• Fluprednisolone (administration & dosage, analogs & derivatives)
• Glucocorticoids (administration & dosage)
• Humans
• Intraocular Pressure (physiology)
• Male
• Middle Aged
• Prednisolone (administration & dosage, analogs & derivatives)
• Uveitis, Anterior (drug therapy, pathology, physiopathology)
• Young Adult