Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections

Bruce E Silverstein,1 Timothy W Morris,2 Lynne S Gearinger,2 Heleen H DeCory,2 Timothy L Comstock21Shasta Eye Medical Group Inc, Redding, CA, 2Bausch and Lomb Inc, Rochester, NY, USABackground: The purpose of this study was to determine the efficacy of besifloxacin ophthalmic suspension 0.6% when us...

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Autores principales: Silverstein BE, Morris TW, Gearinger LS, DeCory HH, Comstock TL
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Publicado: Dove Medical Press 2012
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spelling oai:doaj.org-article:295304b480c54ffb87fae764ca57e3792021-12-02T02:29:37ZBesifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections1177-54671177-5483https://doaj.org/article/295304b480c54ffb87fae764ca57e3792012-11-01T00:00:00Zhttp://www.dovepress.com/besifloxacin-ophthalmic-suspension-06-in-the-treatment-of-bacterial-co-a11645https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Bruce E Silverstein,1 Timothy W Morris,2 Lynne S Gearinger,2 Heleen H DeCory,2 Timothy L Comstock21Shasta Eye Medical Group Inc, Redding, CA, 2Bausch and Lomb Inc, Rochester, NY, USABackground: The purpose of this study was to determine the efficacy of besifloxacin ophthalmic suspension 0.6% when used in the treatment of bacterial conjunctivitis infections due to Pseudomonas aeruginosa.Methods: We undertook a post hoc analysis of clinical outcomes in patients with bacterial conjunctivitis due to P. aeruginosa across four prospective, multicenter, double-masked, randomized, controlled, clinical studies of besifloxacin ophthalmic suspension 0.6%. Efficacy outcomes included bacterial eradication and clinical resolution of the baseline infection at follow-up visits. Bacterial eradication was defined as the absence of ocular bacterial species present at or above threshold at baseline, while clinical resolution was defined as grade 0 ocular discharge and bulbar conjunctival injection. Safety outcomes included the incidence of adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings. Patient outcomes were summarized and bacterial eradication and clinical resolution rates integrated.Results: Of 1317 patients with culture-confirmed bacterial conjunctivitis across four clinical studies, nine (0.7%) were infected with P. aeruginosa at baseline, and of these, five were randomized to treatment with besifloxacin ophthalmic suspension 0.6%. Bacterial eradication of the baseline infection was observed at both follow-up visits in all five patients. Clinical resolution was achieved in two of five patients by the first follow-up visit and four of five patients by the second follow-up visit. There were no adverse events reported in these patients. There were no clinically meaningful biomicroscopy findings or changes in ophthalmoscopy or visual acuity.Conclusion: The incidence of bacterial conjunctivitis due to P. aeruginosa was low. Treatment of patients with P. aeruginosa infections with besifloxacin ophthalmic suspension 0.6% led to bacterial eradication of P. aeruginosa by the first follow-up visit and high rates of clinical resolution.Keywords: bacterial conjunctivitis, besifloxacin ophthalmic suspension, besifloxacin, conjunctivitis, Pseudomonas aeruginosaSilverstein BEMorris TWGearinger LSDeCory HHComstock TLDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2012, Iss default, Pp 1987-1996 (2012)
institution DOAJ
collection DOAJ
language EN
topic Ophthalmology
RE1-994
spellingShingle Ophthalmology
RE1-994
Silverstein BE
Morris TW
Gearinger LS
DeCory HH
Comstock TL
Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections
description Bruce E Silverstein,1 Timothy W Morris,2 Lynne S Gearinger,2 Heleen H DeCory,2 Timothy L Comstock21Shasta Eye Medical Group Inc, Redding, CA, 2Bausch and Lomb Inc, Rochester, NY, USABackground: The purpose of this study was to determine the efficacy of besifloxacin ophthalmic suspension 0.6% when used in the treatment of bacterial conjunctivitis infections due to Pseudomonas aeruginosa.Methods: We undertook a post hoc analysis of clinical outcomes in patients with bacterial conjunctivitis due to P. aeruginosa across four prospective, multicenter, double-masked, randomized, controlled, clinical studies of besifloxacin ophthalmic suspension 0.6%. Efficacy outcomes included bacterial eradication and clinical resolution of the baseline infection at follow-up visits. Bacterial eradication was defined as the absence of ocular bacterial species present at or above threshold at baseline, while clinical resolution was defined as grade 0 ocular discharge and bulbar conjunctival injection. Safety outcomes included the incidence of adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings. Patient outcomes were summarized and bacterial eradication and clinical resolution rates integrated.Results: Of 1317 patients with culture-confirmed bacterial conjunctivitis across four clinical studies, nine (0.7%) were infected with P. aeruginosa at baseline, and of these, five were randomized to treatment with besifloxacin ophthalmic suspension 0.6%. Bacterial eradication of the baseline infection was observed at both follow-up visits in all five patients. Clinical resolution was achieved in two of five patients by the first follow-up visit and four of five patients by the second follow-up visit. There were no adverse events reported in these patients. There were no clinically meaningful biomicroscopy findings or changes in ophthalmoscopy or visual acuity.Conclusion: The incidence of bacterial conjunctivitis due to P. aeruginosa was low. Treatment of patients with P. aeruginosa infections with besifloxacin ophthalmic suspension 0.6% led to bacterial eradication of P. aeruginosa by the first follow-up visit and high rates of clinical resolution.Keywords: bacterial conjunctivitis, besifloxacin ophthalmic suspension, besifloxacin, conjunctivitis, Pseudomonas aeruginosa
format article
author Silverstein BE
Morris TW
Gearinger LS
DeCory HH
Comstock TL
author_facet Silverstein BE
Morris TW
Gearinger LS
DeCory HH
Comstock TL
author_sort Silverstein BE
title Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections
title_short Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections
title_full Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections
title_fullStr Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections
title_full_unstemmed Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with Pseudomonas aeruginosa infections
title_sort besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis patients with pseudomonas aeruginosa infections
publisher Dove Medical Press
publishDate 2012
url https://doaj.org/article/295304b480c54ffb87fae764ca57e379
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