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E. Donnenfeld, E.J. Holland, R. Stewart, L.R. Grillone, Bromfenac Study Group; Topical XibromTM 0.1%, an Investigational NSAID, Significantly and Rapidly Decreased Post–Cataract Surgery Inflammation and Reduced Ocular Pain . Invest. Ophthalmol. Vis. Sci. 2005;46(13):791.
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Purpose: To evaluate the efficacy and safety of XibromTM (bromfenac ophthalmic solution) 0.1%, compared with placebo (vehicle) dosed b.i.d. for 14 days following cataract surgery with a 14 day follow–up for safety, in two Phase III randomized, placebo controlled studies conducted under a common protocol. Methods: Subjects with Summed (cell + flare) Ocular Inflammation Score (SOIS) ≥3 following cataract surgery, in the absence of any anti–inflammatory medication, were randomly assigned to bromfenac or placebo (2:1). Treatment was initiated 16–32 hours following surgery. Efficacy assessments: days 3, 8, 15, 22 and 29. Key secondary efficacy endpoints included mean change from baseline for SOIS prior to receipt of any rescue medication and time to resolution of ocular pain. Ocular and systemic safety was assessed throughout the study. Results: Eligible subjects (527) with mean baseline SOIS=3.7, were treated with bromfenac 0.1% (356) or placebo (171). Mean change in SOIS from baseline was statistically significant on days 3, 8 and 15 following initiation of treatment. Day 3 mean change was 1.4 (bromfenac) vs. placebo 0.9 (p<0.0002); day 8 mean change was 2.4 (bromfenac) vs. placebo 1.1 (p<0.0001), and at day 15, mean change was 2.9 (bromfenac) vs. placebo 1.5 (p<0.0001). The mean number of days to resolution of ocular pain for bromfenac was 1.9 vs. placebo 5.9 (p<0.0001). Placebo treated patients had more ocular adverse events. Conclusions: Bromfenac ophthalmic solution 0.1%, a b.i.d. NSAID was effective in reducing post–cataract surgery inflammation as early as the first post–treatment visit. Bromfenac was effective for treating ocular inflammation (mean change from SOIS baseline) and decreasing the days for resolution of ocular pain. Bromfenac was well tolerated with fewer ocular adverse events reported compared with placebo.
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