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M. Ohji, Y. Tano, T. Hida, T. Sekiya, T. Ogawa, DFBA Study Group; Efficacy and Safety Results of a Phase III Study of Difluprednate Ophthalmic Emulsion(DFBA), 0.05% in Postoperative Inflammation. Invest. Ophthalmol. Vis. Sci. 2007;48(13):3903.
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To assess the safety and efficacy of difluprednate ophthalmic emulsion (DFBA) 0.05% for the treatment of postoperative inflammation.
Multicenter, randomized, double-masked, parallel-group, comparative study. Patients were randomized in a 1:1 ratio to receive 1 drop of either DFBA 0.05% or betamethasone (BM) 0.1% in the affected eye QID for 14 days. Patients were 20 years of age or older and had postoperative ocular inflammation with anterior chamber cell scores of 2 or higher. The study was designed to show the noninferiority of DFBA compared to BM. The study drug instillation started from next day of surgery. Efficacy was measured at Days 3, 7 and 14. The primary endpoint was the change from Baseline in the anterior chamber cell score at Day 14; secondary endpoints were: a) the changes in cell score at Days 3 and 7; b) the numbers of patients showing a cell score of 0 at Days 3, 7 and 14; c) the changes from Baseline in anterior chamber flare score at Days 3, 7 and 14; and d) the changes from Baseline in the total score of signs or symptoms at Days 3, 7 and 14. Safety measurements were made during the study period.
Of the 200 patients in the study, 198 (99 in each group) were included in the safety analysis, and 182 (86 in the DFBA, 96 in the BM group) completed the study and were included in the efficacy evaluation. In the evaluation of the primary endpoints, the non-inferiority hypothesis that DFBA is not inferior to BM for the treatment of postoperative inflammation was verified. No differences were found between the 2 groups. As for the changes in the total sign score, the DFBA group showed better improvement compared to the BM group at Day 7. As for the changes in the total symptom score, there were significant differences between the 2 groups at all of the observation days. The incidences of increased IOP were 6/99 patients on DFBA and 2/99 patients on BM treatment, and 5 patients in the DFBA group received IOP-lowering drugs. All increased IOP resolved with or without any medical intervention. Almost of all other adverse events and abnormal changes in laboratory value were mild to moderate.
The efficacy of DFBA in postoperative inflammation was confirmed to be comparable or better than that of BM. Increased IOP in the DFBA group recovered with or without IOP-lowering medications and no particularly problematic events were noted.
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