A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

Abstract

PurposeThe aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075%) compared with DuraSite® vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery.MethodsA multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15.ResultsAt Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001). At each of the postsurgical time points (Days 1, 8, 15, and 29), proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively) had no pain (a VAS score of 0) compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively), and at each time point, these differences in proportions were statistically significant (P<0.001). More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4%) compared to those in the vehicle group (54/85; 63.5%). There were no new safety signals reported.ConclusionBromfenac 0.075% in DuraSite is safe, well tolerated, and effective at reducing inflammation and preventing pain associated with cataract surgery.

Bromfenac 0.09% ophthalmic solution for postoperative pain and ocular discomfort after cataract surgery with phacoemulsification

“…The incidence of reported pain ranged between 6% and 90% during the postoperative period (29,34,42,45-47). Our study did not show statistically significant difference between groups but is in accordance with the reports demonstrating lower incidence of pain (42,45,46,(48)(49)(50). In addition, our results confirm that the median time for resolution of pain is 1-4 days (34,42).…”

“…В литературата се съобщава за честота на болката в постоперативния период между 6% и 90% (29, 34,42,[45][46][47]. Нашето изследване не показва зависимост на честотата на болката от рандомизирането, но е в съответствие с публикации, посочващи сравнително ниска честота на това оплакване (42,45,46,(48)(49)(50). Освен това потвърждава предишни данни за отзвучаване на постоперативната болка средно за 1-4 дни (34,42).…”

Non-steroidal anti-inflammatory drugs versus corticosteroids for controlling inflammation after uncomplicated cataract surgery

“…We excluded eight studies because comparisons differed from those specified for this review, for example an NSAID plus a corticosteroid versus a placebo or an NSAID plus a corticosteroid versus an NSAID alone (EUCTR2009-017031-18-NL; ISRCTN02628492; Luo 2013; NCT00407017; NCT00698724; NCT01193504; Nishino 2009; Ramakrishnan 2015); in one study the comparison was unclear (NCT00433225). Six other studies did not include an either NSAID arm or a corticosteroid arm (Burde 1972; Chang 2016; Corbett 1993; Hosseini 2016; Meconi 1998; Pollack 2017). Seven studies either were not randomized or we could not tell whether they were randomized (Hossain 2010; Liou 1991; Miyake 1998; Miyake 2000; Ozkurt 2003; Turan-Vural 2013; Waseem 2009).…”

Postoperative management in cataract surgery: nepafenac and preservative‐free diclofenac compared

“…Bolded text indicates p ≤ 0.05 was considered statistically significant. Hosseini et al 2016). According to VAS analysis, preservative-free diclofenac caused less discomfort, itching, pain and burning sensation than did preserved diclofenac (Moisseiev & Varssano 2011).…”