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Judith A Hutcheson, Dragana McMullen, Kamran Hosseini; Clinical Response of 0.075% Bromfenac in DuraSite® on Ocular Inflammation and Pain Post Cataract Surgery. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1473.
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To evaluate the efficacy and safety of topical ocular twice daily (BID) administration of 0.075% Bromfenac in DuraSite® compared with vehicle in subjects post cataract surgery. Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) and DuraSite is a topical ocular drug delivery formulation that faciliates ocular retention of ophthalmic medications.
This was a prospective, randomized, double-masked clinical trial. Subjects scheduled to undergo cataract surgery were required to have both an Anterior Chamber Cell (ACC) grade of 0 and a visual analog scale (VAS) score of 0 at baseline to be eligible. Subjects were randomized to receive either Bromfenac or vehicle in a 2:1 ratio. Subjects dosed BID 1 day prior to surgery, the day of surgery, and for 14 days post-surgery. The primary efficacy endpoint was the proportion of subjects with an ACC grade of 0 by Day 15. The secondary efficacy endpoint was the proportion of subjects who achieved an ocular pain score of 0 (no pain) at each post-surgical VAS assessment.
Overall, 268 subjects were enrolled, 254 (94.8%) received at least 1 dose of study treatment, and 172 (64.2%) completed the study. The average age was 68.9 (24 to 87 years): 101 (37.7%) male and 167 (62.3%) female. Demographic results were similar between the treatment groups. Primary endpoint results were statistically significant (p<0.01): more Bromfenac subjects had an ACC grade of 0 by Day 15 -- 59.8% (107/180) compared with 21.8% (19/88) in the vehicle group. This is about 45% higher than any other Phase 3 trial with alternative Bromfenac formulations for this indication. Secondary efficacy results were also statistically significant (p<0.001): more Bromfenac subjects had an ocular VAS pain score of 0 on Day 1 -- 71.1% (128/180) compared with 46.6% (41/88) in the vehicle group. Pain was also significantly reduced (p≤0.001) at both Days 8 and 15 in the Bromfenac group. The overall incidence of adverse events (AEs) was similar between the Bromfenac and vehicle groups (30.8% and 43.5%, respectively; p=0.051); the majority of AEs in both groups were non-ocular and of mild severity.
Topical ocular BID administration of 0.075% Bromfenac in DuraSite ophthalmic solution, instilled 1 day prior, the day of, and for 14 days post cataract surgery, is a safe and effective treatment for inflammation and pain.
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