A randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis

Jay S Pepose,1,2 Abhijit Narvekar,3 Wenlei Liu,4 Reza Haque3 1Pepose Vision Institute, Chesterfield, MO, USA; 2Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St Louis, MO, USA; 3Ophthalmics, Shire, A Takeda Company, Lexington, MA, USA; 4Biostatistics and...

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Autores principales:	Pepose JS, Narvekar A, Liu W, Haque R
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	adenoviral conjunctivitis dexamethasone povidone-iodine randomized controlled trial Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/fd94c98e353b43fdb4be0a176e71653c
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spelling	oai:doaj.org-article:fd94c98e353b43fdb4be0a176e71653c2021-12-02T02:22:44ZA randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis1177-5483https://doaj.org/article/fd94c98e353b43fdb4be0a176e71653c2019-03-01T00:00:00Zhttps://www.dovepress.com/a-randomized-controlled-trial-of-povidone-iodinedexamethasone-ophthalm-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Jay S Pepose,1,2 Abhijit Narvekar,3 Wenlei Liu,4 Reza Haque3 1Pepose Vision Institute, Chesterfield, MO, USA; 2Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St Louis, MO, USA; 3Ophthalmics, Shire, A Takeda Company, Lexington, MA, USA; 4Biostatistics and Programming, Shire, A Takeda Company, Lexington, MA, USA Purpose: To evaluate the clinical safety and efficacy of povidone-iodine (PVP-I) 0.6%/dexamethasone (DEX) 0.1% ophthalmic suspension vs vehicle in patients with clinically suspected acute viral conjunctivitis. Patients and methods: This was a randomized, double-masked, parallel-group, vehicle-controlled study. Adults with a clinical diagnosis of suspected acute viral conjunctivitis were randomized 1:1 to PVP-I/DEX ophthalmic suspension or vehicle bilaterally four times daily for 5 days (Days 1–5). Evaluation was on Days 1, 3 (+1-day window), and 6 (+1). Patients with signs of acute viral conjunctivitis at the Day 6 visit received open-label PVP-I/DEX for five additional days and were evaluated on Day 11–14. The primary efficacy endpoint was clinical resolution of acute viral conjunctivitis in the study eye at the Day 6 visit. Results: Overall, 132 patients were randomized and received treatment (PVP-I/DEX, n=66; vehicle, n=66); 38 patients continued into the open-label portion of the study. Not enough patients with confirmed adenoviral conjunctivitis (n=32/132) were enrolled to assess the primary endpoint, although there were some efficacy trends in the PVP-I/DEX group for global clinical score (sum of watery conjunctival discharge and bulbar conjunctival redness). There were no serious treatment-emergent adverse events (TEAEs) and no patients discontinued due to a TEAE. In the masked phase, 56.1% of patients receiving PVP-I/DEX experienced at least one TEAE vs 43.9% in the vehicle group; 78.9% of patients in the open-label phase experienced at least one TEAE. Most TEAEs were mild in severity. Conclusion: PVP-I/DEX ophthalmic suspension administered for ≤14 days had a favorable safety profile and was generally well tolerated. Keywords: adenoviral conjunctivitis, dexamethasone, povidone-iodine, randomized controlled trialPepose JSNarvekar ALiu WHaque RDove Medical Pressarticleadenoviral conjunctivitisdexamethasonepovidone-iodinerandomized controlled trialOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 13, Pp 535-544 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	adenoviral conjunctivitis dexamethasone povidone-iodine randomized controlled trial Ophthalmology RE1-994
spellingShingle	adenoviral conjunctivitis dexamethasone povidone-iodine randomized controlled trial Ophthalmology RE1-994 Pepose JS Narvekar A Liu W Haque R A randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis
description	Jay S Pepose,1,2 Abhijit Narvekar,3 Wenlei Liu,4 Reza Haque3 1Pepose Vision Institute, Chesterfield, MO, USA; 2Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St Louis, MO, USA; 3Ophthalmics, Shire, A Takeda Company, Lexington, MA, USA; 4Biostatistics and Programming, Shire, A Takeda Company, Lexington, MA, USA Purpose: To evaluate the clinical safety and efficacy of povidone-iodine (PVP-I) 0.6%/dexamethasone (DEX) 0.1% ophthalmic suspension vs vehicle in patients with clinically suspected acute viral conjunctivitis. Patients and methods: This was a randomized, double-masked, parallel-group, vehicle-controlled study. Adults with a clinical diagnosis of suspected acute viral conjunctivitis were randomized 1:1 to PVP-I/DEX ophthalmic suspension or vehicle bilaterally four times daily for 5 days (Days 1–5). Evaluation was on Days 1, 3 (+1-day window), and 6 (+1). Patients with signs of acute viral conjunctivitis at the Day 6 visit received open-label PVP-I/DEX for five additional days and were evaluated on Day 11–14. The primary efficacy endpoint was clinical resolution of acute viral conjunctivitis in the study eye at the Day 6 visit. Results: Overall, 132 patients were randomized and received treatment (PVP-I/DEX, n=66; vehicle, n=66); 38 patients continued into the open-label portion of the study. Not enough patients with confirmed adenoviral conjunctivitis (n=32/132) were enrolled to assess the primary endpoint, although there were some efficacy trends in the PVP-I/DEX group for global clinical score (sum of watery conjunctival discharge and bulbar conjunctival redness). There were no serious treatment-emergent adverse events (TEAEs) and no patients discontinued due to a TEAE. In the masked phase, 56.1% of patients receiving PVP-I/DEX experienced at least one TEAE vs 43.9% in the vehicle group; 78.9% of patients in the open-label phase experienced at least one TEAE. Most TEAEs were mild in severity. Conclusion: PVP-I/DEX ophthalmic suspension administered for ≤14 days had a favorable safety profile and was generally well tolerated. Keywords: adenoviral conjunctivitis, dexamethasone, povidone-iodine, randomized controlled trial
format	article
author	Pepose JS Narvekar A Liu W Haque R
author_facet	Pepose JS Narvekar A Liu W Haque R
author_sort	Pepose JS
title	A randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis
title_short	A randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis
title_full	A randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis
title_fullStr	A randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis
title_full_unstemmed	A randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis
title_sort	randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/fd94c98e353b43fdb4be0a176e71653c
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A randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis

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