Netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation

Francesco Faraldi,1 Vincenzo Papa,2 Daria Rasà,2 Debora Santoro,2 Simona Russo21Struttura Complessa Oculistica III, Presidio Ospedaliero Oftalmico, Torino, Italy; 2Medical Affairs, SIFI SpA, Aci S Antonio, Catania, ItalyPurpose: To compare the efficacy and safety of 0.1% dexamethasone/0.3...

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Autores principales:	Faraldi F, Papa V, Ras&agrave; D, Santoro D, Russo S
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/88e9a4f1384f41e7b5022c6f73025c57
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spelling	oai:doaj.org-article:88e9a4f1384f41e7b5022c6f73025c572021-12-02T03:07:13ZNetilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation1177-54671177-5483https://doaj.org/article/88e9a4f1384f41e7b5022c6f73025c572013-06-01T00:00:00Zhttp://www.dovepress.com/netilmicindexamethasone-fixed-combination-in-the-treatment-of-conjunct-a13434https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Francesco Faraldi,1 Vincenzo Papa,2 Daria Rasà,2 Debora Santoro,2 Simona Russo21Struttura Complessa Oculistica III, Presidio Ospedaliero Oftalmico, Torino, Italy; 2Medical Affairs, SIFI SpA, Aci S Antonio, Catania, ItalyPurpose: To compare the efficacy and safety of 0.1% dexamethasone/0.3% netilmicin (Netildex), with that of 0.1% dexamethasone/0.3% tobramycin (Tobradex) in the treatment of external ocular inflammation requiring antibiotic therapy.Methods: In this randomized, double-blind study, 139 subjects with conjunctival inflammation associated with signs of ocular infection were treated with Netildex (n = 71) or Tobradex (n = 68) four times daily for 6 days. The primary efficacy analysis was based on the percentage of patients with at least a 50% decrease in conjunctival hyperemia at the endpoint visit (Day 6 [± 1]) with respect to baseline (responder rate). An equivalence margin of 20% was set for this study. A follow-up visit was performed at Day 14 (± 1). Other efficacy parameters were: conjunctival edema, conjunctival discharge, lid hyperemia, lid edema, presence of ocular infection, and symptoms of ocular discomfort. Safety evaluations included intraocular pressure, visual acuity, and adverse events.Results: At Day 6, a decrease of conjunctival hyperemia was observed in 87.3% and 90.9% of the patients treated with Netildex and Tobradex, respectively. The 95% confidence interval for the difference between groups (–15.3 ÷ 8.0) satisfied the equivalence hypothesis. Subjects treated with Netildex had a better control of lid hyperemia (P = 0.016), tearing (P = 0.001), burning (P = 0.007), and stinging (P = 0.004). No adverse reactions were observed during the study except one case of keratitis in the Tobradex group.Conclusion: Netildex was as effective and safe as Tobradex in reducing signs and symptoms in patients with conjunctival inflammation when ocular infection was suspected.Keywords: conjunctivitis, dexamethasone, netilmicin, red eyeFaraldi FPapa VRas&agrave; DSantoro DRusso SDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2013, Iss default, Pp 1239-1244 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Faraldi F Papa V Ras&agrave; D Santoro D Russo S Netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation
description	Francesco Faraldi,1 Vincenzo Papa,2 Daria Rasà,2 Debora Santoro,2 Simona Russo21Struttura Complessa Oculistica III, Presidio Ospedaliero Oftalmico, Torino, Italy; 2Medical Affairs, SIFI SpA, Aci S Antonio, Catania, ItalyPurpose: To compare the efficacy and safety of 0.1% dexamethasone/0.3% netilmicin (Netildex), with that of 0.1% dexamethasone/0.3% tobramycin (Tobradex) in the treatment of external ocular inflammation requiring antibiotic therapy.Methods: In this randomized, double-blind study, 139 subjects with conjunctival inflammation associated with signs of ocular infection were treated with Netildex (n = 71) or Tobradex (n = 68) four times daily for 6 days. The primary efficacy analysis was based on the percentage of patients with at least a 50% decrease in conjunctival hyperemia at the endpoint visit (Day 6 [± 1]) with respect to baseline (responder rate). An equivalence margin of 20% was set for this study. A follow-up visit was performed at Day 14 (± 1). Other efficacy parameters were: conjunctival edema, conjunctival discharge, lid hyperemia, lid edema, presence of ocular infection, and symptoms of ocular discomfort. Safety evaluations included intraocular pressure, visual acuity, and adverse events.Results: At Day 6, a decrease of conjunctival hyperemia was observed in 87.3% and 90.9% of the patients treated with Netildex and Tobradex, respectively. The 95% confidence interval for the difference between groups (–15.3 ÷ 8.0) satisfied the equivalence hypothesis. Subjects treated with Netildex had a better control of lid hyperemia (P = 0.016), tearing (P = 0.001), burning (P = 0.007), and stinging (P = 0.004). No adverse reactions were observed during the study except one case of keratitis in the Tobradex group.Conclusion: Netildex was as effective and safe as Tobradex in reducing signs and symptoms in patients with conjunctival inflammation when ocular infection was suspected.Keywords: conjunctivitis, dexamethasone, netilmicin, red eye
format	article
author	Faraldi F Papa V Ras&agrave; D Santoro D Russo S
author_facet	Faraldi F Papa V Ras&agrave; D Santoro D Russo S
author_sort	Faraldi F
title	Netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation
title_short	Netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation
title_full	Netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation
title_fullStr	Netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation
title_full_unstemmed	Netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation
title_sort	netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/88e9a4f1384f41e7b5022c6f73025c57
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Netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation

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