Effect of alcaftadine 0.25% on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials

Joseph B Ciolino,1 Eugene B McLaurin,2 Nicholas P Marsico,3 Stacey L Ackerman,4 Julia M Williams,5 Linda Villanueva,5 David A Hollander5 1Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA, USA; 2Total Eye Care, P.A., Memphis, TN, USA; 3East West Ey...

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Autores principales:	Ciolino JB, McLaurin EB, Marsico NP, Ackerman SL, Williams JM, Villanueva L, Hollander DA
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2015
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/fa7a29bb102d4a639fa25dc601dc8107
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spelling	oai:doaj.org-article:fa7a29bb102d4a639fa25dc601dc81072021-12-02T06:25:31ZEffect of alcaftadine 0.25% on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials1177-5483https://doaj.org/article/fa7a29bb102d4a639fa25dc601dc81072015-05-01T00:00:00Zhttp://www.dovepress.com/effect-of-alcaftadine-025-on-ocular-itch-associated-with-seasonal-or-p-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Joseph B Ciolino,1 Eugene B McLaurin,2 Nicholas P Marsico,3 Stacey L Ackerman,4 Julia M Williams,5 Linda Villanueva,5 David A Hollander5 1Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA, USA; 2Total Eye Care, P.A., Memphis, TN, USA; 3East West Eye Institute, Los Angeles, CA, USA; 4Philadelphia Eye Associates, Philadelphia, PA, USA; 5Allergan, Inc., Irvine, CA, USA Purpose: Seasonal and perennial allergic conjunctivitis represent the majority of cases of ocular allergy. This analysis was designed to evaluate the efficacy and safety of once-daily alcaftadine 0.25% in preventing ocular itching associated with seasonal or perennial allergic conjunctivitis.Subjects and methods: Pooled data from two double-masked, multicenter, placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis were analyzed. Subjects randomized to receive treatment with alcaftadine 0.25% or placebo were challenged with seasonal (grass, ragweed, trees) or perennial (cat dander, cat hair, dog dander, dust mites, cockroach) allergens, 16 hours after treatment instillation. The primary efficacy measure was subject-evaluated mean ocular itching at 3 minutes post-CAC. Secondary measures included ocular itching at 5 and 7 minutes post-CAC. The proportion of subjects with minimal itch (itch score <1) and zero itch (itch score =0), and safety were also assessed.Results: A total of 189 subjects enrolled in the two studies were treated with alcaftadine or placebo. Overall, 129 subjects were challenged with seasonal allergens and 60 subjects were challenged with perennial allergens. Alcaftadine 0.25% achieved a statistically significant reduction in mean itch score at 3, 5, and 7 minutes post-CAC compared with placebo in subjects challenged with seasonal allergens (P<0.0001 at all time points) and those challenged with perennial allergens (P<0.0001 at all time points). A higher percentage of subjects treated with alcaftadine compared with placebo achieved minimal itch (P≤0.001 versus placebo at all time points) and zero itch (P<0.05 at all time points except 7 minutes for perennial) when challenged with either seasonal or perennial allergens. No treatment-related or serious adverse events were reported.Conclusion: Once-daily alcaftadine 0.25% ophthalmic solution was well tolerated and demonstrated effective relief of ocular itching in subjects challenged with allergens classic for triggering either seasonal or perennial allergic conjunctivitis. Keywords: lastacaft, seasonal allergen, perennial allergen, allergic rhinoconjunctivitis, conjunctival allergen challengeCiolino JBMcLaurin EBMarsico NPAckerman SLWilliams JMVillanueva LHollander DADove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2015, Iss default, Pp 765-772 (2015)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Ciolino JB McLaurin EB Marsico NP Ackerman SL Williams JM Villanueva L Hollander DA Effect of alcaftadine 0.25% on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials
description	Joseph B Ciolino,1 Eugene B McLaurin,2 Nicholas P Marsico,3 Stacey L Ackerman,4 Julia M Williams,5 Linda Villanueva,5 David A Hollander5 1Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA, USA; 2Total Eye Care, P.A., Memphis, TN, USA; 3East West Eye Institute, Los Angeles, CA, USA; 4Philadelphia Eye Associates, Philadelphia, PA, USA; 5Allergan, Inc., Irvine, CA, USA Purpose: Seasonal and perennial allergic conjunctivitis represent the majority of cases of ocular allergy. This analysis was designed to evaluate the efficacy and safety of once-daily alcaftadine 0.25% in preventing ocular itching associated with seasonal or perennial allergic conjunctivitis.Subjects and methods: Pooled data from two double-masked, multicenter, placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis were analyzed. Subjects randomized to receive treatment with alcaftadine 0.25% or placebo were challenged with seasonal (grass, ragweed, trees) or perennial (cat dander, cat hair, dog dander, dust mites, cockroach) allergens, 16 hours after treatment instillation. The primary efficacy measure was subject-evaluated mean ocular itching at 3 minutes post-CAC. Secondary measures included ocular itching at 5 and 7 minutes post-CAC. The proportion of subjects with minimal itch (itch score <1) and zero itch (itch score =0), and safety were also assessed.Results: A total of 189 subjects enrolled in the two studies were treated with alcaftadine or placebo. Overall, 129 subjects were challenged with seasonal allergens and 60 subjects were challenged with perennial allergens. Alcaftadine 0.25% achieved a statistically significant reduction in mean itch score at 3, 5, and 7 minutes post-CAC compared with placebo in subjects challenged with seasonal allergens (P<0.0001 at all time points) and those challenged with perennial allergens (P<0.0001 at all time points). A higher percentage of subjects treated with alcaftadine compared with placebo achieved minimal itch (P≤0.001 versus placebo at all time points) and zero itch (P<0.05 at all time points except 7 minutes for perennial) when challenged with either seasonal or perennial allergens. No treatment-related or serious adverse events were reported.Conclusion: Once-daily alcaftadine 0.25% ophthalmic solution was well tolerated and demonstrated effective relief of ocular itching in subjects challenged with allergens classic for triggering either seasonal or perennial allergic conjunctivitis. Keywords: lastacaft, seasonal allergen, perennial allergen, allergic rhinoconjunctivitis, conjunctival allergen challenge
format	article
author	Ciolino JB McLaurin EB Marsico NP Ackerman SL Williams JM Villanueva L Hollander DA
author_facet	Ciolino JB McLaurin EB Marsico NP Ackerman SL Williams JM Villanueva L Hollander DA
author_sort	Ciolino JB
title	Effect of alcaftadine 0.25% on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials
title_short	Effect of alcaftadine 0.25% on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials
title_full	Effect of alcaftadine 0.25% on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials
title_fullStr	Effect of alcaftadine 0.25% on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials
title_full_unstemmed	Effect of alcaftadine 0.25% on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials
title_sort	effect of alcaftadine 0.25% on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials
publisher	Dove Medical Press
publishDate	2015
url	https://doaj.org/article/fa7a29bb102d4a639fa25dc601dc8107
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Effect of alcaftadine 0.25% on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials

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