Abstract
Purpose: :
To evaluate the efficacy and safety of low-concentration, modified bromfenac ophthalmic solution administered once daily for treatment of ocular inflammation and pain associated with cataract surgery.
Methods: :
This was a multi-center, randomized, double-masked, placebo-controlled, clinical trial. Subjects were randomized to receive either bromfenac ophthalmic solution (n=110) or placebo (n=110) dosed once daily beginning 1 day before cataract surgery, on the day of surgery, and continuing through 14 days post-surgery. Subjects were evaluated for efficacy and safety on days 1, 3, 8, and 15 post-surgery. An additional safety analysis was conducted at day 22 or 7 days after the investigational product was discontinued. The primary efficacy endpoint was the proportion of subjects with cleared ocular inflammation by day 15 as measured by the summed ocular inflammation score (SOIS). The secondary efficacy endpoint was the proportion of subjects who were pain-free at day 1.
Results: :
A significantly larger proportion of subjects in the bromfenac group had cleared ocular inflammation (SOIS=0) by day 15 compared to the placebo group (P<0.05). The proportion of subjects who were pain-free at days 1, 3, 8, and 15 was also significantly higher in the bromfenac group compared to placebo (P<0.005). The incidence of any adverse events was significantly lower in the bromfenac group compared to the placebo group (P<0.005).
Conclusions: :
Low-concentration, modified bromfenac ophthalmic solution administered once daily was safe and effective for the treatment of ocular inflammation and pain associated with cataract surgery.
Clinical Trial: :
http://www.clinicaltrials.gov 01367249
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • treatment outcomes of cataract surgery • inflammation