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Difluprednate 0.05% versus prednisolone acetate 1% for endogenous anterior uveitis: a phase III, multicenter, randomized study.
- Source :
-
Investigative ophthalmology & visual science [Invest Ophthalmol Vis Sci] 2014 May 06; Vol. 55 (5), pp. 2993-3002. Date of Electronic Publication: 2014 May 06. - Publication Year :
- 2014
-
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.<br />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.<br />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.<br />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.).
- Subjects :
- Adolescent
Adult
Aged
Aged, 80 and over
Analysis of Variance
Anterior Chamber
Child
Double-Blind Method
Drug Administration Schedule
Female
Fluprednisolone administration & dosage
Humans
Intraocular Pressure physiology
Male
Middle Aged
Prednisolone administration & dosage
Uveitis, Anterior pathology
Uveitis, Anterior physiopathology
Young Adult
Anti-Inflammatory Agents administration & dosage
Fluprednisolone analogs & derivatives
Glucocorticoids administration & dosage
Prednisolone analogs & derivatives
Uveitis, Anterior drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1552-5783
- Volume :
- 55
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Investigative ophthalmology & visual science
- Publication Type :
- Academic Journal
- Accession number :
- 24677110
- Full Text :
- https://doi.org/10.1167/iovs.13-12660