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T. W. Morris, W. Haas, L. S. Brunner, G. E. Zurenko, J. C. Lee, D. W. Usner, M. P. Paterno, T. L. Comstock; Clinical Efficacy of Besifloxacin Ophthalmic Suspension; Integrated Microbiological Results of 3 Trials for Topical Treatment of Bacterial Conjunctivitis. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5945.
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© ARVO (1962-2015); The Authors (2016-present)
Besifloxacin is a novel fluoroquinolone developed to treat bacterial conjunctivitis (BC). This integrated analysis summarizes microbiological results pooled across 3 clinical studies conducted to evaluate the safety and efficacy of besifloxacin ophthalmic suspension 0.6% administered topically TID for 5 days.
Microbiology results were integrated across 3 randomized, double-masked, parallel-group studies of patients with culture-confirmed BC (Studies 373 and 433 were vehicle-controlled and Study 434 was active-controlled with 0.5% moxifloxacin solution). Assessments included quantitative bacteriology and antimicrobial susceptibility testing of all bacterial pathogens recovered at or above threshold from conjunctival swabs of qualified study eyes at each of 3 clinical visits by study subjects.
The most frequently isolated pathogens in all studies were Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus (13.6% methicillin-resistant MRSA), and Staphylococcus epidermidis (45.9% methicillin-resistant MRSE). Despite the prevalence of multi-drug resistant isolates, besifloxacin MIC90 values for these species were 0.03, 0.06, 0.5, and 0.5 ug/mL, respectively, and staphylococcal MIC90s were at least 2- to 4-fold lower than all 6 ophthalmic comparators. There was no evidence for development of resistance to besifloxacin or other fluoroquinolones during treatment.
In 3 separate clinical studies besifloxacin showed consistently high microbiological eradication and potent in vitro activity against BC isolates, including the increasingly prevalent MRSA and MRSE strains encountered in this community-acquired disease.
Clinical Trial: :
www.clinicaltrials.gov NCT00622908, NCT00347932, NCT00348348
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