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James Gow, James Boyce, Harvey Reiser, Robert Berry, Jung Dao, Simon Chandler; Randomized, Placebo-Controlled, Integrated Phase III Clinical Trials of a Once Daily, Low-Concentration, Modified Bromfenac Ophthalmic Solution Following Cataract Surgery: Focus on Zero to Trace Anterior Chamber Inflammation. Invest. Ophthalmol. Vis. Sci. 2013;54(15):125.
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To evaluate in a post-hoc analysis the reduction of ocular inflammation to 0 or trace anterior chamber inflammation of low-concentration, modified bromfenac ophthalmic solution dosed once daily compared to placebo following cataract surgery in 2 integrated clinical trials.
Subjects undergoing unilateral cataract surgery (phacoemulsification or extracapsular cataract extraction) with posterior chamber IOL implantation were randomized to either low-concentration, modified bromfenac ophthalmic solution (n=222) or placebo (n=218). Once daily dosing began 1 day before cataract surgery, continued on the day of surgery, and through post-surgery Day 14. The proportion of subjects with trace anterior chamber inflammation, defined as a Summed Ocular Inflammation Score (SOIS) of 0-0.5 (0-5 cells in the anterior chamber and flare grade of 0), was assessed at Days 1, 3, 8, and 15. Safety was assessed by the incidence and frequency of ocular and systemic adverse events, and ophthalmological evaluations (visual acuity, slit lamp examination, intraocular pressure, and dilated funduscopic examination). Statistical significance was determined using a Fisher’s exact test.
In the intent-to-treat population, subjects had a mean age of 68.0 years, were predominantly Caucasian (74.8%), and included a higher percentage of female subjects (65.2%). Baseline characteristics were similar across treatment groups. A significantly higher proportion of subjects achieved trace ocular inflammation in the bromfenac group compared to placebo as early as Day 3 (27.9% vs. 13.8%, p=0.0008), continued on Day 8 (55.4% vs. 24.3%, p < 0.0001), and through Day 15 (71.2% vs. 39.4%, p < 0.0001). Compared to placebo, low-concentration, modified bromfenac ophthalmic solution dosed once daily produced a lower overall incidence of ocular adverse events.
Low concentration, modified bromfenac ophthalmic solution dosed once daily effectively and safely reduced ocular inflammation associated with cataract surgery.
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