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

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 s...

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Autores principales:	Malhotra R, Gira J, Berdy GJ, Brusatti R
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2012
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/e4f699980d804b389677dc6cd7d6bc6f
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spelling	oai:doaj.org-article:e4f699980d804b389677dc6cd7d6bc6f2021-12-02T04:58:47ZSafety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study1177-54671177-5483https://doaj.org/article/e4f699980d804b389677dc6cd7d6bc6f2012-06-01T00:00:00Zhttp://www.dovepress.com/safety-of-besifloxacin-ophthalmic-suspension-06-as-a-prophylactic-anti-a10033https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Ranjan 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 &ge;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 (&plusmn;1 day) and 28 (&plusmn;2 days) following surgery, and intraocular pressure and best-corrected visual acuity measured on days 1, 7 (&plusmn;1 day), and 28 (&plusmn;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 &ge; 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&reg;, phacoemulsification, endophthalmitisMalhotra RGira JBerdy GJBrusatti RDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2012, Iss default, Pp 855-863 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Malhotra R Gira J Berdy GJ Brusatti R Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study
description	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 &ge;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 (&plusmn;1 day) and 28 (&plusmn;2 days) following surgery, and intraocular pressure and best-corrected visual acuity measured on days 1, 7 (&plusmn;1 day), and 28 (&plusmn;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 &ge; 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&reg;, phacoemulsification, endophthalmitis
format	article
author	Malhotra R Gira J Berdy GJ Brusatti R
author_facet	Malhotra R Gira J Berdy GJ Brusatti R
author_sort	Malhotra R
title	Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study
title_short	Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study
title_full	Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study
title_fullStr	Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study
title_full_unstemmed	Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study
title_sort	safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study
publisher	Dove Medical Press
publishDate	2012
url	https://doaj.org/article/e4f699980d804b389677dc6cd7d6bc6f
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Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study

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