Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model

Edward J Meier,1 Gail L Torkildsen,2 Paul J Gomes,3 Mark C Jasek4 1Apex Eye, Mason, OH, USA; 2Andover Eye, Andover, MA, USA; 3Allergy, Ora, Inc., Andover, MA, USA; 4Eyevance Pharmaceuticals, TX, USA Purpose: The purpose of these Phase III studies was to evaluate the efficacy and safety of cetirizi...

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Autores principales:	Meier EJ, Torkildsen GL, Gomes PJ, Jasek MC
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	Allergic conjunctivitis cetirizine ocular itching safety topical administration Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/dd456f467fde4c778cdab3f61ac7aca1
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spelling	oai:doaj.org-article:dd456f467fde4c778cdab3f61ac7aca12021-12-02T02:33:04ZPhase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model1177-5483https://doaj.org/article/dd456f467fde4c778cdab3f61ac7aca12018-12-01T00:00:00Zhttps://www.dovepress.com/phase-iii-trials-examining-the-efficacy-of-cetirizine-ophthalmic-solut-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Edward J Meier,1 Gail L Torkildsen,2 Paul J Gomes,3 Mark C Jasek4 1Apex Eye, Mason, OH, USA; 2Andover Eye, Andover, MA, USA; 3Allergy, Ora, Inc., Andover, MA, USA; 4Eyevance Pharmaceuticals, TX, USA Purpose: The purpose of these Phase III studies was to evaluate the efficacy and safety of cetirizine ophthalmic solution 0.24% compared with vehicle in the treatment of allergen-induced conjunctivitis using the Ora conjunctival allergen challenge (CAC)® model.Methods: The single-center (Study 1) and multi-center (Study 2), double-masked, randomized, vehicle-controlled, parallel group, CAC studies were conducted over ~5 weeks and four study visits. The study design only differed in entry criteria: Study 2 required more severe allergic conjunctivitis symptoms. Subjects were screened for an allergen response at Visits 1 and 2 and then randomized at Visit 3. Approximately 100 subjects were randomized in each study. The primary efficacy endpoints were ocular itching and conjunctival redness 15 minutes and 8 hours post-treatment, post-CAC.Results: Cetirizine treatment administered 15 minutes or 8 hours prior to CAC resulted in significantly lower ocular itching at all time points post-CAC (P<0.0001) compared to vehicle in both studies. Conjunctival redness measured by the investigator was significantly lower after cetirizine treatment compared to vehicle at 7 minutes post-CAC at both 15 minutes and 8 hours post-treatment in both studies (P<0.05). All secondary endpoints were in favor and confirmatory of cetirizine efficacy with significant improvement in chemosis, eyelid swelling, tearing, ciliary redness, and episcleral redness, as well as nasal symptoms (rhinorrhea, nasal pruritus, ear or palatal pruritus, and nasal congestion) post-CAC. The most robust treatment differences were observed in Study 2 where more severe symptoms were required for study entry (P<0.05). No safety concerns for cetirizine ophthalmic solution 0.24% were identified.Conclusion: Cetirizine ophthalmic solution 0.24% was shown to be efficacious in the treatment of ocular and nasal signs and symptoms associated with allergic conjunctivitis and demonstrated a favorable safety profile. Clinical efficacy was demonstrated with a 15-minute onset of action and an ~8-hour duration of action. Keywords: ocular allergy, cetirizine, ocular itching, safety, topical administrationMeier EJTorkildsen GLGomes PJJasek MCDove Medical PressarticleAllergic conjunctivitiscetirizineocular itchingsafetytopical administrationOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 2617-2628 (2018)
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 Meier EJ Torkildsen GL Gomes PJ Jasek MC Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model
description	Edward J Meier,1 Gail L Torkildsen,2 Paul J Gomes,3 Mark C Jasek4 1Apex Eye, Mason, OH, USA; 2Andover Eye, Andover, MA, USA; 3Allergy, Ora, Inc., Andover, MA, USA; 4Eyevance Pharmaceuticals, TX, USA Purpose: The purpose of these Phase III studies was to evaluate the efficacy and safety of cetirizine ophthalmic solution 0.24% compared with vehicle in the treatment of allergen-induced conjunctivitis using the Ora conjunctival allergen challenge (CAC)® model.Methods: The single-center (Study 1) and multi-center (Study 2), double-masked, randomized, vehicle-controlled, parallel group, CAC studies were conducted over ~5 weeks and four study visits. The study design only differed in entry criteria: Study 2 required more severe allergic conjunctivitis symptoms. Subjects were screened for an allergen response at Visits 1 and 2 and then randomized at Visit 3. Approximately 100 subjects were randomized in each study. The primary efficacy endpoints were ocular itching and conjunctival redness 15 minutes and 8 hours post-treatment, post-CAC.Results: Cetirizine treatment administered 15 minutes or 8 hours prior to CAC resulted in significantly lower ocular itching at all time points post-CAC (P<0.0001) compared to vehicle in both studies. Conjunctival redness measured by the investigator was significantly lower after cetirizine treatment compared to vehicle at 7 minutes post-CAC at both 15 minutes and 8 hours post-treatment in both studies (P<0.05). All secondary endpoints were in favor and confirmatory of cetirizine efficacy with significant improvement in chemosis, eyelid swelling, tearing, ciliary redness, and episcleral redness, as well as nasal symptoms (rhinorrhea, nasal pruritus, ear or palatal pruritus, and nasal congestion) post-CAC. The most robust treatment differences were observed in Study 2 where more severe symptoms were required for study entry (P<0.05). No safety concerns for cetirizine ophthalmic solution 0.24% were identified.Conclusion: Cetirizine ophthalmic solution 0.24% was shown to be efficacious in the treatment of ocular and nasal signs and symptoms associated with allergic conjunctivitis and demonstrated a favorable safety profile. Clinical efficacy was demonstrated with a 15-minute onset of action and an ~8-hour duration of action. Keywords: ocular allergy, cetirizine, ocular itching, safety, topical administration
format	article
author	Meier EJ Torkildsen GL Gomes PJ Jasek MC
author_facet	Meier EJ Torkildsen GL Gomes PJ Jasek MC
author_sort	Meier EJ
title	Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model
title_short	Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model
title_full	Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model
title_fullStr	Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model
title_full_unstemmed	Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model
title_sort	phase iii trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/dd456f467fde4c778cdab3f61ac7aca1
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Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model

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