Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects

Ranjan P Malhotra,1 Edward Meier,2 Gail Torkildsen,3 Paul J Gomes,4 Mark C Jasek5 1Ophthalmology Associates, St Louis, MO, USA; 2Apex Eye, Mason, OH, USA; 3Andover Eye, Andover, MA, USA; 4Ora, Inc., Andover, MA, USA; 5Eyevance Pharmaceuticals, Fort Worth, TX, USA Purpose: The studies reported here...

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Autores principales:	Malhotra RP, Meier E, Torkildsen G, Gomes PJ, Jasek MC
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	Allergic conjunctivitis cetirizine ocular itching safety topical administration Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/caff7eba4c7749339fa7884f74f90a87
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spelling	oai:doaj.org-article:caff7eba4c7749339fa7884f74f90a872021-12-02T01:01:59ZSafety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects1177-5483https://doaj.org/article/caff7eba4c7749339fa7884f74f90a872019-02-01T00:00:00Zhttps://www.dovepress.com/safety-of-cetirizine-ophthalmic-solution-024-for-the-treatment-of-alle-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Ranjan P Malhotra,1 Edward Meier,2 Gail Torkildsen,3 Paul J Gomes,4 Mark C Jasek5 1Ophthalmology Associates, St Louis, MO, USA; 2Apex Eye, Mason, OH, USA; 3Andover Eye, Andover, MA, USA; 4Ora, Inc., Andover, MA, USA; 5Eyevance Pharmaceuticals, Fort Worth, TX, USA Purpose: The studies reported here aimed to assess the safety and tolerability of cetirizine ophthalmic solution 0.24%, a new topical ophthalmic medication approved by the US Food and Drug Administration for the treatment of ocular itching associated with allergic conjunctivitis.Patients and methods: Three clinical studies evaluated cetirizine ophthalmic solution 0.24% administration: a Phase I prospective, single-center, open-label, pharmacokinetic (PK) study (N=11) evaluating single-dose administration and twice-daily (BID) administration for 1 week in healthy adults, and two Phase III, multi-center, randomized, double-masked, vehicle-controlled, parallel-group studies evaluating the safety and tolerability in adult and pediatric populations (2–18 years of age) for up to 6 consecutive weeks. The first safety and tolerability study evaluated cetirizine BID (study 1, N=512), while the second study examined cetirizine three times daily (TID) (study 2, N=516). Each study assessed best corrected visual acuity, slit-lamp biomicroscopy, IOP, dilated ophthalmoscopy, treatment-emergent adverse events, vital signs, urine pregnancy test, and physical examination (general health, head, eyes, ears, nose, and throat). The PK study also measured hematology, blood chemistry, and urinalysis, while the two Phase III studies additionally assessed corneal endothelial cell counts (ECC) and ECC density in a subset of subjects (via specular microscopy), and drug administration tolerability.Results: Bilateral administration of cetirizine ophthalmic solution 0.24% resulted in low systemic exposure in the PK study and was associated with a low incidence of mild adverse events. There were no drug-related severe or serious adverse events. The tolerability scores between the active and vehicle groups were comparable, demonstrating high comfort in the administration of cetirizine ophthalmic solution 0.24%.Conclusion: Cetirizine ophthalmic solution 0.24% dosed BID or TID demonstrated an acceptable safety profile and was well-tolerated when administered to subjects aged ≥2 years. Keywords: ocular allergy, antihistamine, ocular itching, tolerability, topical administration  Malhotra RPMeier ETorkildsen GGomes PJJasek MCDove Medical PressarticleAllergic conjunctivitiscetirizineocular itchingsafetytopical administrationOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 13, Pp 403-413 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	Allergic conjunctivitis cetirizine ocular itching safety topical administration Ophthalmology RE1-994
spellingShingle	Allergic conjunctivitis cetirizine ocular itching safety topical administration Ophthalmology RE1-994 Malhotra RP Meier E Torkildsen G Gomes PJ Jasek MC Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects
description	Ranjan P Malhotra,1 Edward Meier,2 Gail Torkildsen,3 Paul J Gomes,4 Mark C Jasek5 1Ophthalmology Associates, St Louis, MO, USA; 2Apex Eye, Mason, OH, USA; 3Andover Eye, Andover, MA, USA; 4Ora, Inc., Andover, MA, USA; 5Eyevance Pharmaceuticals, Fort Worth, TX, USA Purpose: The studies reported here aimed to assess the safety and tolerability of cetirizine ophthalmic solution 0.24%, a new topical ophthalmic medication approved by the US Food and Drug Administration for the treatment of ocular itching associated with allergic conjunctivitis.Patients and methods: Three clinical studies evaluated cetirizine ophthalmic solution 0.24% administration: a Phase I prospective, single-center, open-label, pharmacokinetic (PK) study (N=11) evaluating single-dose administration and twice-daily (BID) administration for 1 week in healthy adults, and two Phase III, multi-center, randomized, double-masked, vehicle-controlled, parallel-group studies evaluating the safety and tolerability in adult and pediatric populations (2–18 years of age) for up to 6 consecutive weeks. The first safety and tolerability study evaluated cetirizine BID (study 1, N=512), while the second study examined cetirizine three times daily (TID) (study 2, N=516). Each study assessed best corrected visual acuity, slit-lamp biomicroscopy, IOP, dilated ophthalmoscopy, treatment-emergent adverse events, vital signs, urine pregnancy test, and physical examination (general health, head, eyes, ears, nose, and throat). The PK study also measured hematology, blood chemistry, and urinalysis, while the two Phase III studies additionally assessed corneal endothelial cell counts (ECC) and ECC density in a subset of subjects (via specular microscopy), and drug administration tolerability.Results: Bilateral administration of cetirizine ophthalmic solution 0.24% resulted in low systemic exposure in the PK study and was associated with a low incidence of mild adverse events. There were no drug-related severe or serious adverse events. The tolerability scores between the active and vehicle groups were comparable, demonstrating high comfort in the administration of cetirizine ophthalmic solution 0.24%.Conclusion: Cetirizine ophthalmic solution 0.24% dosed BID or TID demonstrated an acceptable safety profile and was well-tolerated when administered to subjects aged ≥2 years. Keywords: ocular allergy, antihistamine, ocular itching, tolerability, topical administration
format	article
author	Malhotra RP Meier E Torkildsen G Gomes PJ Jasek MC
author_facet	Malhotra RP Meier E Torkildsen G Gomes PJ Jasek MC
author_sort	Malhotra RP
title	Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects
title_short	Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects
title_full	Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects
title_fullStr	Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects
title_full_unstemmed	Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects
title_sort	safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/caff7eba4c7749339fa7884f74f90a87
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Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects

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