Safety and Efficacy of Moxifloxacin-Dexamethasone Eyedrops as Treatment for Bacterial Ocular Infection Associated with Bacterial Blepharitis

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dc.contributor.authorBelfort, Rubens [UNIFESP]
dc.contributor.authorGabriel, Luis [UNIFESP]
dc.contributor.authorMartins Bispo, Paulo Jose [UNIFESP]
dc.contributor.authorMuccioli, Cristina [UNIFESP]
dc.contributor.authorZacharias Serapicos, Patricia Cabral [UNIFESP]
dc.contributor.authorClark, Linda
dc.contributor.authorBell, Belinda
dc.contributor.authorBartell, John
dc.contributor.authorStroman, David W.
dc.contributor.authorHoefling-Lima, Ana Luisa [UNIFESP]
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionAlcon Res Ltd
dc.date.accessioned2016-01-24T14:27:11Z
dc.date.available2016-01-24T14:27:11Z
dc.date.issued2012-05-01
dc.description.abstractTreatments that offer two medications in a fixed combination have the potential to offer efficacious and safe treatment with advantages such as a regimen that is simpler than administering two separate solutions. This study evaluated the safety and efficacy of fixed-combination versus concomitant moxifloxacin 0.5% and dexamethasone 0.1% ocular solutions for the treatment of bacterial ocular inflammation and infection.The clinical study design was a randomized, double-masked, active-controlled, parallel-group trial of 102 subjects with bacterial blepharitis in which two patients also had bacterial conjunctivitis. All subjects received two bottles of study medication: either a fixed combination of moxifloxacin 0.5%/dexamethasone 0.1% ophthalmic solution and placebo eye drops (fixed-dose group), or moxifloxacin 0.5% ophthalmic solution and dexamethasone 0.1% (concomitant group). One drop of each study medication was instilled bilaterally four times per day for 7 days. Clinical resolution, signs, symptoms, and safety were assessed. Microbiological specimens were collected from the eyelid margin and conjunctivae of each eye from each patient at the time of enrollment and at the exit visit.Clinical resolution occurred similarly in both groups (81.6% of eyes, fixed-dose group; 82.3% of eyes, concomitant group). Moreover, the microbiological efficacy of the treatment was also similar for both the fixed-dose group (84%) and the concomitant group (83%). Ocular symptoms and signs improved over time, with no significant differences between groups after 7 days of treatment, except the fixed-dose group had significantly more eyes with clinical resolution in eyelid erythema (100%, n = 98/98, fixed-dose group; 92.7%, n = 89/96, concomitant group; P = 0.0194) and eyelid scaling/crusting (98%, n = 96/98, fixed-dose group; 89.6%; n = 86/96 eyes, concomitant group; P = 0.0337). Both regimens were safe and well tolerated.The fixed-dose combination of moxifloxacin, 0.5% and dexamethasone, 0.1% was therapeutically equivalent and as well tolerated as the concomitant dosage.en
dc.description.affiliationUniversidade Federal de São Paulo, Vis Inst, BR-04023062 São Paulo, Brazil
dc.description.affiliationAlcon Res Ltd, Ft Worth, TX 76134 USA
dc.description.affiliationUnifespUniversidade Federal de São Paulo, Vis Inst, BR-04023062 São Paulo, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipAlcon Laboratories, Inc.
dc.format.extent416-426
dc.identifierhttp://dx.doi.org/10.1007/s12325-012-0018-8
dc.identifier.citationAdvances in Therapy. New York: Springer, v. 29, n. 5, p. 416-426, 2012.
dc.identifier.doi10.1007/s12325-012-0018-8
dc.identifier.issn0741-238X
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/34847
dc.identifier.wosWOS:000305225900003
dc.language.isoeng
dc.publisherSpringer
dc.relation.ispartofAdvances in Therapy
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.rights.licensehttp://www.springer.com/open+access/authors+rights?SGWID=0-176704-12-683201-0
dc.subjectBlepharitisen
dc.subjectConjunctivitisen
dc.subjectDexamethasoneen
dc.subjectKeratitisen
dc.subjectMoxifloxacinen
dc.titleSafety and Efficacy of Moxifloxacin-Dexamethasone Eyedrops as Treatment for Bacterial Ocular Infection Associated with Bacterial Blepharitisen
dc.typeinfo:eu-repo/semantics/article
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