Besifloxacin Ophthalmic Suspension 0.6% Compared with Gatifloxacin Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis in Neonates.
Drugs R D
; 17(1): 167-175, 2017 Mar.
Article
em En
| MEDLINE
| ID: mdl-28078599
ABSTRACT
PURPOSE:
The aim of this study was to evaluate the safety and efficacy of topical besifloxacin ophthalmic suspension 0.6% compared with gatifloxacin ophthalmic solution 0.3% in the treatment of bacterial conjunctivitis in neonates.METHODS:
This was a multicenter, randomized, double-masked, parallel group study. Subjects ≤31 days of age with severity grade ≥1 (scale 0-3) for both conjunctival discharge and conjunctival hyperemia were randomized to besifloxacin or gatifloxacin instilled three times daily for 7 days, and completed five study visits (three clinic visits and two phone calls). Primary endpoints included clinical resolution (absence of both conjunctival discharge and conjunctival hyperemia) at visit 5 (day 8 or 9) and ocular and non-ocular treatment-emergent adverse events (AEs). Bacterial eradication was a secondary endpoint.RESULTS:
Thirty-three subjects were included in the intent-to-treat (ITT) population. All were aged <28 days, with a mean (standard deviation) age of 15.5 days (6.0), and 57.6% were female. Twenty-two subjects had culture-confirmed conjunctivitis in at least one eye (modified ITT [mITT] population), most often with Gram-positive bacteria. Visit 5 clinical resolution and bacterial eradication rates were comparable among besifloxacin- and gatifloxacin-treated study eyes (clinical resolution 12/16 [75.0%] vs. 12/17 [70.6%] for the ITT population, and 11/13 [84.6%] vs. 7/9 [77.8%] for the mITT population; bacterial eradication 12/13 [92.3%] vs. 8/9 [88.9%] for the mITT population, respectively). No AEs were reported in the besifloxacin treatment group, and AEs reported in the gatifloxacin group were considered not treatment-related.CONCLUSIONS:
In this small study in neonates, both besifloxacin and gatifloxacin appeared effective and safe in the treatment of bacterial conjunctivitis. Larger studies are warranted.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Soluções Oftálmicas
/
Azepinas
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Conjuntivite Bacteriana
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Fluoroquinolonas
/
Antibacterianos
Tipo de estudo:
Clinical_trials
Limite:
Female
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Humans
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Male
/
Newborn
Idioma:
En
Revista:
Drugs R D
Assunto da revista:
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2017
Tipo de documento:
Article
País de afiliação:
Estados Unidos