Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes

Timothy W Morris1, Lynne S Gearinger1, Dale W Usner2, Michael R Paterno2, Heleen H DeCory3, Timothy L Comstock3, Wolfgang Haas11Microbiology and Sterilization Sciences, 2Clinical Affairs, 3Global Pharmaceutical Medical Affairs, Bausch &amp; Lomb, Rochester, NY, USAPurpose: To assess clinical...

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Autores principales:	Morris TW, Gearinger LS, Usner DW, Paterno MR, DeCory HH, Comstock TL, Haas W
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2011
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/40ad818b85f24df58936812d1a27d004
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spelling	oai:doaj.org-article:40ad818b85f24df58936812d1a27d0042021-12-02T06:49:43ZIntegrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes1177-54671177-5483https://doaj.org/article/40ad818b85f24df58936812d1a27d0042011-09-01T00:00:00Zhttp://www.dovepress.com/integrated-analysis-of-three-bacterial-conjunctivitis-trials-of-besifl-a8327https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Timothy W Morris1, Lynne S Gearinger1, Dale W Usner2, Michael R Paterno2, Heleen H DeCory3, Timothy L Comstock3, Wolfgang Haas11Microbiology and Sterilization Sciences, 2Clinical Affairs, 3Global Pharmaceutical Medical Affairs, Bausch &amp; Lomb, Rochester, NY, USAPurpose: To assess clinical antimicrobial efficacy results obtained with besifloxacin ophthalmic suspension, 0.6%, administered three times a day (TID) for 5 days, integrated across three clinical trials of bacterial conjunctivitis and to investigate any microbiological eradication failures.Methods: Clinical microbiological eradication data from three randomized, double-masked, parallel group studies of patients with bacterial conjunctivitis (two vehicle controlled; one active controlled with moxifloxacin ophthalmic solution, 0.5%) were integrated. All bacterial samples isolated at baseline above the species-specific threshold value were subjected to antimicrobial susceptibility testing. Samples isolated at subsequent visits were subjected to susceptibility testing and pulsed-field gel electrophoresis (PFGE) to investigate the cause of eradication failures and the potential for drug resistance development.Results: Visit 2 (day 4 or 5) and visit 3 (day 8) overall microbiological eradication rates were 92.2% and 88.4% for besifloxacin ophthalmic suspension compared with 61.4% and 72.5% for vehicle and 91.6% and 85.7% for moxifloxacin ophthalmic solution. Visit 2 and visit 3 microbiological eradication rates for Gram-positive and Gram-negative isolates and for individual species were consistent with the overall eradication rates. The majority of observed eradication failures in any treatment group were due to the persistence of the pathogen isolated at baseline. Eradication failures in the besifloxacin treatment group were not associated with lower antimicrobial susceptibility at baseline. PFGE data showed that the majority of bacterial strains in eyes with eradication failures were identical to the strain isolated at baseline; these eradication failures were not associated with a lower antimicrobial susceptibility at the follow-up visit.Conclusion: Treatment with besifloxacin ophthalmic suspension, 0.6%, administered TID for 5 days resulted in microbiological eradication rates that were &ge; 90% across the three clinical studies for the common pathogens of bacterial conjunctivitis. The few eradication failures were not due to fluoroquinolone resistance at baseline and/or resistance development during treatment.Keywords: besifloxcin, moxifloxacin, antimicrobial efficacy, bacterial conjunctivitisMorris TWGearinger LSUsner DWPaterno MRDeCory HHComstock TLHaas WDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2011, Iss default, Pp 1359-1367 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Morris TW Gearinger LS Usner DW Paterno MR DeCory HH Comstock TL Haas W Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes
description	Timothy W Morris1, Lynne S Gearinger1, Dale W Usner2, Michael R Paterno2, Heleen H DeCory3, Timothy L Comstock3, Wolfgang Haas11Microbiology and Sterilization Sciences, 2Clinical Affairs, 3Global Pharmaceutical Medical Affairs, Bausch &amp; Lomb, Rochester, NY, USAPurpose: To assess clinical antimicrobial efficacy results obtained with besifloxacin ophthalmic suspension, 0.6%, administered three times a day (TID) for 5 days, integrated across three clinical trials of bacterial conjunctivitis and to investigate any microbiological eradication failures.Methods: Clinical microbiological eradication data from three randomized, double-masked, parallel group studies of patients with bacterial conjunctivitis (two vehicle controlled; one active controlled with moxifloxacin ophthalmic solution, 0.5%) were integrated. All bacterial samples isolated at baseline above the species-specific threshold value were subjected to antimicrobial susceptibility testing. Samples isolated at subsequent visits were subjected to susceptibility testing and pulsed-field gel electrophoresis (PFGE) to investigate the cause of eradication failures and the potential for drug resistance development.Results: Visit 2 (day 4 or 5) and visit 3 (day 8) overall microbiological eradication rates were 92.2% and 88.4% for besifloxacin ophthalmic suspension compared with 61.4% and 72.5% for vehicle and 91.6% and 85.7% for moxifloxacin ophthalmic solution. Visit 2 and visit 3 microbiological eradication rates for Gram-positive and Gram-negative isolates and for individual species were consistent with the overall eradication rates. The majority of observed eradication failures in any treatment group were due to the persistence of the pathogen isolated at baseline. Eradication failures in the besifloxacin treatment group were not associated with lower antimicrobial susceptibility at baseline. PFGE data showed that the majority of bacterial strains in eyes with eradication failures were identical to the strain isolated at baseline; these eradication failures were not associated with a lower antimicrobial susceptibility at the follow-up visit.Conclusion: Treatment with besifloxacin ophthalmic suspension, 0.6%, administered TID for 5 days resulted in microbiological eradication rates that were &ge; 90% across the three clinical studies for the common pathogens of bacterial conjunctivitis. The few eradication failures were not due to fluoroquinolone resistance at baseline and/or resistance development during treatment.Keywords: besifloxcin, moxifloxacin, antimicrobial efficacy, bacterial conjunctivitis
format	article
author	Morris TW Gearinger LS Usner DW Paterno MR DeCory HH Comstock TL Haas W
author_facet	Morris TW Gearinger LS Usner DW Paterno MR DeCory HH Comstock TL Haas W
author_sort	Morris TW
title	Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes
title_short	Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes
title_full	Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes
title_fullStr	Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes
title_full_unstemmed	Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes
title_sort	integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes
publisher	Dove Medical Press
publishDate	2011
url	https://doaj.org/article/40ad818b85f24df58936812d1a27d004
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Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes

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