May 2007
Volume 48, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2007
A Phase III, Non-Inferiority Study of Difluprednate Ophthalmic Emulsion (DFBA), 0.05% in the Treatment of Anterior Uveitis
Author Affiliations & Notes
  • S. Ohno
    Department of Ophthalmology and Visual Sciences, Hokkaido University Graduate School of Medicine, Hokkaido, Japan
  • M. Mochizuki
    Department of Ophthalmology and Visual Science, Tokyo Medical and Dental University Graduate School, Tokyo, Japan
  • M. Usui
    Department of Ophthalmology, Tokyo Medical University, Tokyo, Japan
  • K. Masuda
    Senju Pharmaceutical Co., Ltd., Osaka, Japan
  • T. Sekiya
    Senju USA Inc, Encino, California
  • T. Ogawa
    Senju USA Inc, Encino, California
  • DFBA Study Group
    Department of Ophthalmology and Visual Sciences, Hokkaido University Graduate School of Medicine, Hokkaido, Japan
  • Footnotes
    Commercial Relationships S. Ohno, Senju Pharmaceutical Co., Ltd., C; M. Mochizuki, Senju Pharmaceutical Co., Ltd., C; M. Usui, Senju Pharmaceutical Co., Ltd., C; K. Masuda, Senju Pharmaceutical Co., Ltd., E; T. Sekiya, Senju USA Inc, E; T. Ogawa, Senju USA Inc, E.
  • Footnotes
    Support None.
Investigative Ophthalmology & Visual Science May 2007, Vol.48, 3904. doi:https://doi.org/
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      S. Ohno, M. Mochizuki, M. Usui, K. Masuda, T. Sekiya, T. Ogawa, DFBA Study Group; A Phase III, Non-Inferiority Study of Difluprednate Ophthalmic Emulsion (DFBA), 0.05% in the Treatment of Anterior Uveitis. Invest. Ophthalmol. Vis. Sci. 2007;48(13):3904. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose:: To assess the efficacy and safety of difluprednate ophthalmic emulsion (DFBA) 0.05% in patients with endogenous anterior uveitis, in comparison with betamethasone (BM) 0.1% ophthalmic solution.

Methods:: 136 patients were randomized to receive either one drop of DFBA 0.05% or one drop of BM 0.1%. Each drug was instilled 4 times daily for 14 days. Observation of symptoms and signs and IOP measurement were performed on Days 0, 3, 7 and 14. In addition, measurement of visual acuity and blood collection for laboratory tests were performed on Days 0 and 14. The primary endpoint was the change from the baseline in anterior chamber cell score on Day 14.

Results:: Improvement of anterior chamber cell score from baseline was comparable between both treatments at day 14, therefore verifying the non-inferiority hypothesis. DFBA was superior to BM on day 7 with regard to proportion of patients with cell score of 1+ or lower (P=0.0298) and total sign score (P=0.0355). Withdrawal from treatment due to symptom aggravation occurred in 3/67 patients on BM and 0/69 patients receiving DFBA. The incidence of increased IOP, a common side effect of corticosteroids, was equal between the two groups.

Conclusions:: Compared to BM, treatment with DFBA produced a significantly more rapid improvement in the clinical signs of anterior uveitis while maintaining a satisfactory safety profile. These data suggest a more potent and rapid anti-inflammatory effect of DFBA, which may provide better treatment for patients with anterior uveitis.

Clinical Trial:: www.clinicaltrials.gov NCT00406887

Keywords: corticosteroids • inflammation • anterior segment 
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