The Safety of Besifloxacin Ophthalmic Suspension 0.6 % Used Three Times Daily for 7 Days in the Treatment of Bacterial ConjunctivitisReportar como inadecuado




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Drugs in RandD

, Volume 13, Issue 4, pp 243–252

First Online: 19 October 2013

Abstract

BackgroundBesifloxacin ophthalmic suspension 0.6 % Besivance; Bausch and Lomb, Rochester, NY, USA was approved by the FDA in 2009 for the treatment of bacterial conjunctivitis, with a recommended 7-day dosing regimen.

ObjectiveThe objective of this study was to compare the safety of besifloxacin ophthalmic suspension 0.6 %, administered three times a day for 7 days, with that of its vehicle.

MethodsThis randomized, multicenter, double-masked, vehicle-controlled, parallel-group study involved 518 patients ≥1 year of age with a clinical diagnosis of bacterial conjunctivitis. Patients were randomized 2:1 to treatment with besifloxacin 0.6 % ophthalmic suspension or vehicle, one drop in the infected eyes TID for 7 days. Main outcomes included the incidence and types of adverse events reported by the subject or observed by the investigator at each study visit.

ResultsThirty-one ocular treatment-emergent adverse events TEAEs were reported by 28 subjects in the study eye; 19 occurred in 17-344 4.9 % besifloxacin patients, and 12 occurred in 11-170 6.5 % vehicle patients p = 0.5362. Only two ocular events mild instillation site reaction, one case in each group were considered -definitely related- to study treatment. One event of self-limited dysgeusia in the besifloxacin group was considered definitely related to treatment; there were no other nonocular TEAEs considered related to treatment. There were no serious adverse events, and other safety outcomes visual acuity, biomicroscopy, ophthalmoscopy were unremarkable.

ConclusionThese findings indicate that besifloxacin ophthalmic suspension 0.6 % is safe in patients aged 1 year and older when used TID for 7 days.

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Autor: Ranjan Malhotra - Stacey Ackerman - Lynne S. Gearinger - Timothy W. Morris - Catherine Allaire

Fuente: https://link.springer.com/







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