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

Invest Ophthalmol Vis Sci. 2014 May 6;55(5):2993-3002. doi: 10.1167/iovs.13-12660.

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.).

Keywords: acute anterior uveitis; corticosteroid; difluprednate; endogenous anterior uveitis; intraocular pressure; noninfectious uveitis; prednisolone; prednisolone acetate; uveitis.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 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
  • Fluprednisolone / analogs & derivatives*
  • Glucocorticoids / administration & dosage*
  • Humans
  • Intraocular Pressure / physiology
  • Male
  • Middle Aged
  • Prednisolone / administration & dosage
  • Prednisolone / analogs & derivatives*
  • Uveitis, Anterior / drug therapy*
  • Uveitis, Anterior / pathology
  • Uveitis, Anterior / physiopathology
  • Young Adult

Substances

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

Associated data

  • ClinicalTrials.gov/NCT01201798