Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study

Abstract

Ranjan Malhotra,1 Joseph Gira,2 Gregg J Berdy,1 Robert Brusatti11Ophthalmology Associates, 2Ophthalmology Consultants, St Louis, MO, USABackground: The purpose of this study was to evaluate the safety and tolerability of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5%, when used for infection prophylaxis following uncomplicated phacoemulsification clear cornea surgery using sutureless corneal incision.Methods: This prospective, two-site, parallel-group, investigator-masked clinical study included patients aged ≥18 years scheduled to undergo phacoemulsification with intraocular lens implantation. Patients received one drop of either besifloxacin ophthalmic suspension or moxifloxacin ophthalmic solution four times daily, beginning 3 days prior to surgery, which was continued for 7 days postoperatively. The primary endpoint was the rate of adverse events. Secondary endpoints included endothelial cell count, central corneal thickness, and overall and central corneal staining measured on days 7 (±1 day) and 28 (±2 days) following surgery, and intraocular pressure and best-corrected visual acuity measured on days 1, 7 (±1 day), and 28 (±2 days) following surgery.Results: Of the 60 patients enrolled, 58 (29 per treatment group) completed the study. No adverse events were reported in either treatment group. Changes in the central corneal thickness, endothelial cell count, and corneal staining were small and similar between treatments at follow-up visits (P ≥ 0.1549). Intraocular pressure was similar between treatment groups at each visit, as was the distribution of best-corrected visual acuity. The final best-corrected visual acuity was 20/30 or better in 85% of the patients.Conclusion: In this study, besifloxacin ophthalmic suspension 0.6% was well tolerated when used prophylactically to prevent postoperative endophthalmitis following sutureless cataract surgery.Keywords: besifloxacin, moxifloxacin, corneal integrity, DuraSite®, phacoemulsification, endophthalmitis