Comparative evaluation of once-daily and twice-daily dosing of topical bromfenac 0.09%: aqueous pharmacokinetics and clinical efficacy study.

Abstract

To evaluate aqueous pharmacokinetics of topical bromfenac 0.09% and compare clinical outcomes of once- and twice-daily dosing in phacoemulsification. Dr. R.P. Center for Ophthalmic Sciences, AIIMS, New Delhi, India. Prospective interventional study. In phase I, single-drop aqueous pharmacokinetics of topical bromfenac was estimated at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 12 hours, and 24 hours using liquid chromatography mass spectrometry in 60 eyes. In phase II, 45 eyes undergoing phacoemulsification were enrolled: group I (control, n = 15), group II (once-daily bromfenac, n = 14), and group III (twice-daily bromfenac, n = 16). Intraoperative pupillary miosis, postoperative anterior chamber (AC) flare, Summed Ocular Inflammation Score (SOIS), central macular thickness (CMT), and pain scores were assessed. Follow-up was performed at 1 day, 7 days, 28 days, and 90 days postoperatively. Half-life of topical bromfenac was 3.6 hours, mean residence time 5.5 hours, and peak concentration (63.73 ng/mL) achieved after 2 hours. Aqueous concentration was more than inhibitory concentration (IC50) at 12 hours but not at 24 hours. Cumulative effect was observed with repeated dosing with aqueous levels more than IC50 in once-daily and twice-daily groups at 5 days. Significant intraoperative miosis was observed in group I. Pain score, AC flare, and SOIS were significantly more in group I (P < .001) and comparable in groups II and III at all timepoints. CMT was comparable in all groups; no case developed cystoid macular edema. Single-dose topical bromfenac did not maintain therapeutic aqueous concentration over 24 hours; however, cumulative effect was observed with repeated dosing. Clinical efficacy of once-daily and twice-daily dosing was comparable.