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Fatma Zaguia, Michael Ross, Mash Darvish, Jean Deschenes; Besifloxacin Ophthalmic Suspension in Patients With Bacterial Keratitis: A Prospective, Randomized Clinical Study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):3659.
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Bacterial keratitis is a serious ocular problem that can, if not appropriately treated, lead to corneal scarring, perforation, endophthalmitis, and ultimately blindness. Current accepted treatment by most ophthalmologists for corneal ulcers involves aggressive therapy with fortified antibiotics typically every hour, round the clock dosing for at least the 48 hours, causing significant distress to patients, as well as compliance issues. Finally, delayed epithelial healing rate and conjunctival/corneal toxicity are known side effects of fortified antibiotics. Besifloxacin ophthalmic suspension is a novel topical fluoroquinolone, specifically developed as an ocular topical preparation. Several in vitro studies have shown a higher potency when compared with earlier fluoroquinolones, however there is limited data about its safety and efficacy in the treatment of bacterial keratitis.
Our study is a multi-site prospective, randomized trial to determine if besifloxacin when compared to fortified tobramycin/vancomycin drops results in non-inferior clinical resolution of bacterial keratitis. Patients with bacterial keratitis were randomized to receive besifloxacin at initially Q4H dosing vs Fortified Tobramycin + Vancomycin at initial Q1H dosing. Complete exams were recorded at initial visit, and at predetermined subsequent visits.
Overall, there were no treatment failures in the besifloxacin group. Median number of days taken for the ulcer to heal between besifloxacin group (13 days) and fortified group (16 days) showed no statistical difference (p=0.5). The group treated with besifloxacin showed statistically significant more rapid epithelialization rate, at mean of 4 days vs 10(p=0.01).
Our preliminary results failed to find a difference in efficacy of besifloxacin, a novel fluoroquinolone in the treatment of bacterial keratitis when compared to traditional combination therapy of fortified antibiotics.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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