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The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery.

ABSTRACT: PURPOSE:To evaluate the efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace (0-5 cells) anterior chamber cells, following cataract surgery with posterior chamber intraocular lens implantation. METHODS:The study designed employed two Phase III, double-masked, placebo-controlled, multicenter clinical trials of 440 subjects, randomized to either bromfenac ophthalmic solution 0.07% (n=222) or placebo (n=218). Subjects self-dosed once daily, beginning 1 day before undergoing cataract surgery with intraocular lens implantation (day -1) and again on the day of surgery (day 0) and for 14 days postoperatively. Follow-up was on days 1, 3, 8, and 15. The outcome measures included the percentage of subjects with zero-to-trace anterior chamber cells at each visit, as determined by the percentage of subjects with ?5 anterior chamber cells, overall anterior chamber cell grades, and summed ocular inflammation score (SOIS) (combined anterior chamber cell and flare scores). RESULTS:The proportion of subjects with zero-to-trace anterior chamber cells was significantly higher in the bromfenac 0.07% group compared with the placebo group as early as day 3 (P=0.0007), continued at day 8 (P<0.0001), and through day 15 (P<0.0001). At day 15, 80.2% of subjects in the bromfenac 0.07% group achieved zero-to-trace anterior chamber cells compared with 47.2% of subjects who did so in the placebo group. The overall anterior chamber cell scores were significantly lower in the bromfenac 0.07% group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). The SOIS were also significantly lower in the bromfenac group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). CONCLUSION:Bromfenac ophthalmic solution 0.07%, dosed once daily was clinically effective in achieving zero-to-trace anterior chamber cell severity after cataract surgery and was superior to placebo in all anterior chamber cell severity and inflammation outcome measures.

SUBMITTER: Silverstein SM

PROVIDER: S-EPMC4037304 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery.

Silverstein Steven M SM Jackson Mitchell A MA Goldberg Damien F DF Muñoz Mauricio M

Clinical ophthalmology (Auckland, N.Z.) 20140516

<h4>Purpose</h4>To evaluate the efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace (0-5 cells) anterior chamber cells, following cataract surgery with posterior chamber intraocular lens implantation.<h4>Methods</h4>The study designed employed two Phase III, double-masked, placebo-controlled, multicenter clinical trials of 440 subjects, randomized to either bromfenac ophthalmic solution 0.07% (n=222) or placebo (n=218). Subjects self-dosed once daily, begi ...[more]

PMID: 24876763

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Project description:IntroductionThis small pilot study is the first direct comparison of the currently marketed formulations of bromfenac (0.07% solution) and nepafenac (0.3% suspension) using identical dosing regimens and including an extra pre-surgical "pulse" dose in patients undergoing cataract surgery.MethodsAdults scheduled for unilateral phacoemulsification with intraocular lens implantation were randomly assigned to bromfenac 0.07% or nepafenac 0.3%, each given once-daily 1 day prior to surgery, on the day of surgery plus an extra dose 1 h before surgery, and for 14 days after surgery. Assessments included summed ocular inflammation score (SOIS), visual acuity (VA), and retinal thickness measured via optical coherence tomography.ResultsThe study population included 49 patients (bromfenac, n = 24; nepafenac, n = 25). The percentage of patients with a SOIS = 0 (no cells or flare) at post-surgical day 15 (primary efficacy endpoint) was statistically similar between the bromfenac (57.1%) and nepafenac (50.0%) treatment groups (intent-to-treat with last observation carried forward) (P = 0.6318). The proportions of patients with an SOIS of 0 at days 3 and 8 were significantly (P < 0.05) higher in the bromfenac group (23.8 and 52.4%, respectively) versus the nepafenac group (0.0 and 20.8%, respectively). Visual acuity was similar between groups at each study visit, as were mean retinal thickness and change from baseline in retinal thickness. Rescue medication (typically difluprednate) was given on or before day 15 to 13 patients in each treatment group (bromfenac, 54.2%; nepafenac, 52.0%). There were no adverse events considered to be related to either treatment.ConclusionsThe results of this small pilot study suggest that once-daily bromfenac 0.07% produces similar benefits with regard to postsurgical inflammation, VA, and retinal thickness as once-daily nepafenac 0.3%, and possibly has a faster onset of anti-inflammatory action, when compared using identical dosing regimens.FundingBausch & Lomb Incorporated.Trial registrationNCT03886779.

Project description:PurposeTo assess the relationship between anterior chamber depth (ACD) and lens thickness (LT), as well as its three main components (anterior and posterior cortex and nucleus thickness), in cataractous and non-cataractous eyes, depending on the axial length (AxL).MethodsAnterior and posterior cortex and nucleus thickness of the crystalline lens, ACD, and AxL were measured using optical low-coherence reflectometry in cataractous and non-cataractous eyes. They were also classified into hyperopia, emmetropia, myopia, and high myopia, depending on AxL; thus, eight subgroups were created. A minimum sample size of 44 eyes (of 44 patients) for each group was recruited. Linear models were fitted for the whole sample and each AxL subgroup to assess if there were differences in the relationships between the crystalline lens variables and ACD, including age as a covariate.ResultsThree hundred seventy cataract patients (237 females, 133 males) and 250 non-cataract controls (180 females, 70 males), aged 70.5 ± 9.4 and 41.9 ± 15.5 years, respectively, were recruited. The mean AxL, ACD, and LT for the cataractous and non-cataractous eyes were 23.90 ± 2.05, 24.11 ± 2.11, 2.64 ± 0.45, and 2.91 ± 0.49, 4.51 ± 0.38, 3.93 ± 0.44 mm, respectively. The inverse relationship of LT, anterior and posterior cortex, and nucleus thickness with ACD was not significantly (p ≥ 0.26) different between cataractous and non-cataractous eyes. Further subclassification of the sample depending on AxL showed that the inverse relationship between the posterior cortex and ACD was no longer significant (p > 0.05) for any non-cataractous AxL group. LT, anterior and posterior cortex, and nucleus thickness was not significantly (p ≥ 0.43) different between cataractous and non-cataractous eyes for the whole sample, and all AxL groups after adjusting for age.ConclusionsThe presence of cataracts does not modify the inverse relationship of the LT, anterior and posterior cortex, and nucleus with ACD. And this relationship does not seem to depend importantly on AxL. Besides, the possible differences in LT, anterior and posterior cortex, and nucleus between cataractous and non-cataractous eyes may not be caused by lens opacification, but possibly by the progressive lens growth due to aging.

Project description:PurposeTo investigate the relationship between early post-operative anterior chamber inflammation (aqueous flare) and central corneal thickness (CCT) after cataract surgery and to evaluate the effect of anti-inflammatory prophylaxis on CCT.SettingDepartment of Ophthalmology, Rigshospitalet-Glostrup, University Hospital Copenhagen, Denmark.DesignPost-hoc analysis of a prospective randomized controlled trial.Patients and methodsA total of 470 participants who underwent standard cataract surgery were randomly allocated to prophylactic treatment with nonsteroidal anti-inflammatory drug (NSAID, groups C and D) or a combination of NSAID and steroid eye drops (groups A and B), commenced either pre-operatively (A and C) or post-operatively on the day of surgery (B and D), or "drop-less surgery" (peri-operative subtenon depot of dexamethasone, group E). Aqueous flare was measured before and three days after surgery. CCT was measured before surgery, three days, three weeks, and three months after surgery. Data were analyzed according to the intention-to-treat method.ResultsDoubling of aqueous flare increased mean CCT by 15.6 microns (95% CI 9.8; 21.3, P<0.001) three days after surgery. Mean CCT increased from 549 microns (95% CI 545; 552) at baseline to 594 microns (95% CI 585; 602) three days after surgery and returned to 551 microns (95% CI 545; 557) three months after surgery. Mean CCT was thinner in group C compared to group A three days after surgery. No difference was found for any other groups or time points.ConclusionIncreased anterior chamber inflammation was associated with significant corneal thickening three days after cataract surgery. Choice of anti-inflammatory regimen seemed to be of no or minimal importance on CCT when the effect of inflammation was accounted for. Corneal thickening is possibly mediated by underlying deterioration of the blood-aqueous barrier and corneal endothelium pump function caused by a post-operative inflammatory response.

Dataset Information

The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery.

Publications

The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery.

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