title: Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study.
abstract: OBJECTIVE
  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.affiliation: Departments of Ophthalmology, Microbiology, and Molecular Biology, Eastern Virginia Medical School, Norfolk, Virginia, United States.
authors.forename: John D
authors.initials: JD
authors.lastname: Sheppard
authors.forename: Melissa M
authors.initials: MM
authors.lastname: Toyos
authors.forename: John H
authors.initials: JH
authors.lastname: Kempen
authors.forename: Paramjit
authors.initials: P
authors.lastname: Kaur
authors.forename: C Stephen
authors.initials: CS
authors.lastname: Foster
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000867:Anterior Chamber; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005477:Fluprednisolone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D014606:Uveitis, Anterior / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; C009935:prednisolone acetate; D005477:Fluprednisolone; D011239:Prednisolone; C015808:difluprednate
keywords: acute anterior uveitis; corticosteroid; difluprednate; endogenous anterior uveitis; intraocular pressure; noninfectious uveitis; prednisolone; prednisolone acetate; uveitis