Efficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after LASIK

Mauro Campos, Cristina Muccioli, Jo&atilde;o BNS Malta, Rafael A Gerade, Andr&eacute; LA Salame, Rubens Belfort JrDepartment of Ophthalmology, Hospital S&atilde;o Paulo, Universidade Federal de S&atilde;o Paulo, BrazilPurpose: To compare the efficacy and tolerability...

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Autores principales:	Mauro Campos, Cristina Muccioli, Jo&atilde;o BNS Malta, et al
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2011
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/d18b34cf6fd342bfb1487d89d8e26e7c
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spelling	oai:doaj.org-article:d18b34cf6fd342bfb1487d89d8e26e7c2021-12-02T05:28:20ZEfficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after LASIK1177-54671177-5483https://doaj.org/article/d18b34cf6fd342bfb1487d89d8e26e7c2011-02-01T00:00:00Zhttp://www.dovepress.com/efficacy-and-tolerability-of-a-combined-gatifloxacin-plus-prednisolone-a6363https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Mauro Campos, Cristina Muccioli, Jo&atilde;o BNS Malta, Rafael A Gerade, Andr&eacute; LA Salame, Rubens Belfort JrDepartment of Ophthalmology, Hospital S&atilde;o Paulo, Universidade Federal de S&atilde;o Paulo, BrazilPurpose: To compare the efficacy and tolerability of a fixed-dose combination of 0.3% gatifloxacin and 1% prednisolone formulation versus the same agents administered separately for prophylaxis in a laser-assisted in situ keratomileusis (LASIK) population.Methods: In a prospective, randomized, double-masked, parallel-group study, 97 patients were evaluated for signs and symptoms of ocular infection or inflammation after bilateral LASIK. Group 1 (50 patients, 100 eyes) received a combined formulation of 0.3% gatifloxacin + 1% prednisolone acetate (Zypred&reg;) plus placebo. Group 2 (47 patients, 94 eyes) received conventional treatment with the same agents from separate vials. The cohorts were similar in age, sex, race, and refractive error. Baseline and postoperative assessments were made on surgery days &mdash;2, 1, 3, and 15 and consisted of visual acuity; intraocular pressure; severity of inflammation of eyelids, conjunctiva, and cornea; tearing; ocular discomfort (foreign-body sensation, itching, or photophobia); and ocular pain. The posterior segment was evaluated at the screening and exit visits.Results: No ocular infection or persistent inflammation was detected in either group at any time. All objective and subjective criteria of efficacy were similar regardless of treatment, with no significant differences between the groups. More patients who were dosed with the combined agent complained of mild ocular discomfort on day 3, but this difference had disappeared by day 15.Conclusion: Post-LASIK topical prophylaxis with combined gatifloxacin + prednisolone eye drops (Zypred&reg;) was well tolerated. This formulation appears to be therapeutically equivalent to conventional dosing with gatifloxacin and prednisolone from individual bottles for topical prophylaxis after laser refractive surgery.Keywords: gatifloxacin, prednisolone, LASIK, prophylaxis Mauro CamposCristina MuccioliJo&atilde;o BNS Maltaet alDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2011, Iss default, Pp 209-214 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Mauro Campos Cristina Muccioli Jo&atilde;o BNS Malta et al Efficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after LASIK
description	Mauro Campos, Cristina Muccioli, Jo&atilde;o BNS Malta, Rafael A Gerade, Andr&eacute; LA Salame, Rubens Belfort JrDepartment of Ophthalmology, Hospital S&atilde;o Paulo, Universidade Federal de S&atilde;o Paulo, BrazilPurpose: To compare the efficacy and tolerability of a fixed-dose combination of 0.3% gatifloxacin and 1% prednisolone formulation versus the same agents administered separately for prophylaxis in a laser-assisted in situ keratomileusis (LASIK) population.Methods: In a prospective, randomized, double-masked, parallel-group study, 97 patients were evaluated for signs and symptoms of ocular infection or inflammation after bilateral LASIK. Group 1 (50 patients, 100 eyes) received a combined formulation of 0.3% gatifloxacin + 1% prednisolone acetate (Zypred&reg;) plus placebo. Group 2 (47 patients, 94 eyes) received conventional treatment with the same agents from separate vials. The cohorts were similar in age, sex, race, and refractive error. Baseline and postoperative assessments were made on surgery days &mdash;2, 1, 3, and 15 and consisted of visual acuity; intraocular pressure; severity of inflammation of eyelids, conjunctiva, and cornea; tearing; ocular discomfort (foreign-body sensation, itching, or photophobia); and ocular pain. The posterior segment was evaluated at the screening and exit visits.Results: No ocular infection or persistent inflammation was detected in either group at any time. All objective and subjective criteria of efficacy were similar regardless of treatment, with no significant differences between the groups. More patients who were dosed with the combined agent complained of mild ocular discomfort on day 3, but this difference had disappeared by day 15.Conclusion: Post-LASIK topical prophylaxis with combined gatifloxacin + prednisolone eye drops (Zypred&reg;) was well tolerated. This formulation appears to be therapeutically equivalent to conventional dosing with gatifloxacin and prednisolone from individual bottles for topical prophylaxis after laser refractive surgery.Keywords: gatifloxacin, prednisolone, LASIK, prophylaxis
format	article
author	Mauro Campos Cristina Muccioli Jo&atilde;o BNS Malta et al
author_facet	Mauro Campos Cristina Muccioli Jo&atilde;o BNS Malta et al
author_sort	Mauro Campos
title	Efficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after LASIK
title_short	Efficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after LASIK
title_full	Efficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after LASIK
title_fullStr	Efficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after LASIK
title_full_unstemmed	Efficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after LASIK
title_sort	efficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after lasik
publisher	Dove Medical Press
publishDate	2011
url	https://doaj.org/article/d18b34cf6fd342bfb1487d89d8e26e7c
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Efficacy and tolerability of a combined gatifloxacin plus prednisolone formulation for topical prophylaxis after LASIK

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