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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.
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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.
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.
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.
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.
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