Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies

Edward Meier,1 Abhijit Narvekar,2 Ganesh R Iyer,2 Harvey B DuBiner,3 Apinya Vutikullird,4 David Wirta,5 Kenneth Sall61Apex Eye, Mason, OH, 2Alcon Research Ltd., Fort Worth, TX, 3Clayton Eye Center, Morrow, GA, 4WCCT Global, Cypress, 5Eye Research Foundation, Newport Beach, 6Sall Eye Researc...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Meier E, Narvekar A, Iyer GR, DuBiner HB, Vutikullird A, Wirta D, Sall K
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2017
Materias:	Ocular allergy allergic conjunctivitis olopatadine pharmacokinetics safety Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/f5dce38dc0a34beb94abeb38f871ad08
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:f5dce38dc0a34beb94abeb38f871ad08
record_format	dspace
spelling	oai:doaj.org-article:f5dce38dc0a34beb94abeb38f871ad082021-12-02T06:22:40ZPharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies1177-5483https://doaj.org/article/f5dce38dc0a34beb94abeb38f871ad082017-04-01T00:00:00Zhttps://www.dovepress.com/pharmacokinetics-and-safety-of-olopatadine-hydrochloride-077-in-health-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Edward Meier,1 Abhijit Narvekar,2 Ganesh R Iyer,2 Harvey B DuBiner,3 Apinya Vutikullird,4 David Wirta,5 Kenneth Sall61Apex Eye, Mason, OH, 2Alcon Research Ltd., Fort Worth, TX, 3Clayton Eye Center, Morrow, GA, 4WCCT Global, Cypress, 5Eye Research Foundation, Newport Beach, 6Sall Eye Research Medical Center, Artesia, CA, USAPurpose: To assess the pharmacokinetics and safety of hydrochloride ophthalmic solution 0.77% olopatadine from 2 independent (Phase I and Phase III, respectively) clinical studies in healthy subjects.Materials and methods: The Phase I, multicenter, randomized (2:1), vehicle-controlled study was conducted in subjects ≥18 years old (N=36) to assess the systemic pharmacokinetics of olopatadine 0.77% following single- and multiple-dose exposures. The Phase III, multicenter, randomized (2:1), vehicle-controlled study was conducted in subjects ≥2 years old (N=499) to evaluate long-term ocular safety of olopatadine 0.77%. Subjects received olopatadine 0.77% or vehicle once daily bilaterally for 7 days in the pharmacokinetic study and 6 weeks in the safety study.Results: In the pharmacokinetic study, olopatadine 0.77% was absorbed slowly and reached a peak plasma concentration (Cmax) of 1.65 ng/mL following single-dose and 1.45 ng/mL following multiple-dose exposures in 2 hours (time to reach maximum plasma concentration [Tmax]). After reaching peak concentrations, olopatadine showed a similar mono-exponential decay following single and multiple doses with mean elimination half-life ranging from 2.90 to 3.40 hours. No accumulation in olopatadine exposure (Cmax and area under the plasma concentration–time curve from 0 to 12 hours) was evident after multiple doses when compared to single dose. In the safety study, treatment-emergent adverse events were reported in 26.7% and 31.4% of subjects with olopatadine 0.77% and vehicle, respectively. Blurred vision was the most frequent ocular treatment-emergent adverse event in both treatment groups (olopatadine 0.77% vs vehicle, 4.8% vs 4.1%). No deaths or serious adverse events were reported during the study.Conclusion: Olopatadine 0.77% had minimal systemic exposure or accumulation in healthy subjects and was well tolerated in both adult and pediatric subjects. Keywords: ocular allergy, allergic conjunctivitis, olopatadine, pharmacokinetics, safetyMeier ENarvekar AIyer GRDuBiner HBVutikullird AWirta DSall KDove Medical PressarticleOcular allergyallergic conjunctivitisolopatadinepharmacokineticssafetyOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 11, Pp 669-681 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ocular allergy allergic conjunctivitis olopatadine pharmacokinetics safety Ophthalmology RE1-994
spellingShingle	Ocular allergy allergic conjunctivitis olopatadine pharmacokinetics safety Ophthalmology RE1-994 Meier E Narvekar A Iyer GR DuBiner HB Vutikullird A Wirta D Sall K Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies
description	Edward Meier,1 Abhijit Narvekar,2 Ganesh R Iyer,2 Harvey B DuBiner,3 Apinya Vutikullird,4 David Wirta,5 Kenneth Sall61Apex Eye, Mason, OH, 2Alcon Research Ltd., Fort Worth, TX, 3Clayton Eye Center, Morrow, GA, 4WCCT Global, Cypress, 5Eye Research Foundation, Newport Beach, 6Sall Eye Research Medical Center, Artesia, CA, USAPurpose: To assess the pharmacokinetics and safety of hydrochloride ophthalmic solution 0.77% olopatadine from 2 independent (Phase I and Phase III, respectively) clinical studies in healthy subjects.Materials and methods: The Phase I, multicenter, randomized (2:1), vehicle-controlled study was conducted in subjects ≥18 years old (N=36) to assess the systemic pharmacokinetics of olopatadine 0.77% following single- and multiple-dose exposures. The Phase III, multicenter, randomized (2:1), vehicle-controlled study was conducted in subjects ≥2 years old (N=499) to evaluate long-term ocular safety of olopatadine 0.77%. Subjects received olopatadine 0.77% or vehicle once daily bilaterally for 7 days in the pharmacokinetic study and 6 weeks in the safety study.Results: In the pharmacokinetic study, olopatadine 0.77% was absorbed slowly and reached a peak plasma concentration (Cmax) of 1.65 ng/mL following single-dose and 1.45 ng/mL following multiple-dose exposures in 2 hours (time to reach maximum plasma concentration [Tmax]). After reaching peak concentrations, olopatadine showed a similar mono-exponential decay following single and multiple doses with mean elimination half-life ranging from 2.90 to 3.40 hours. No accumulation in olopatadine exposure (Cmax and area under the plasma concentration–time curve from 0 to 12 hours) was evident after multiple doses when compared to single dose. In the safety study, treatment-emergent adverse events were reported in 26.7% and 31.4% of subjects with olopatadine 0.77% and vehicle, respectively. Blurred vision was the most frequent ocular treatment-emergent adverse event in both treatment groups (olopatadine 0.77% vs vehicle, 4.8% vs 4.1%). No deaths or serious adverse events were reported during the study.Conclusion: Olopatadine 0.77% had minimal systemic exposure or accumulation in healthy subjects and was well tolerated in both adult and pediatric subjects. Keywords: ocular allergy, allergic conjunctivitis, olopatadine, pharmacokinetics, safety
format	article
author	Meier E Narvekar A Iyer GR DuBiner HB Vutikullird A Wirta D Sall K
author_facet	Meier E Narvekar A Iyer GR DuBiner HB Vutikullird A Wirta D Sall K
author_sort	Meier E
title	Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies
title_short	Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies
title_full	Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies
title_fullStr	Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies
title_full_unstemmed	Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies
title_sort	pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies
publisher	Dove Medical Press
publishDate	2017
url	https://doaj.org/article/f5dce38dc0a34beb94abeb38f871ad08
work_keys_str_mv	AT meiere pharmacokineticsandsafetyofolopatadinehydrochloride077inhealthysubjectswithasymptomaticeyesdatafrom2independentclinicalstudies AT narvekara pharmacokineticsandsafetyofolopatadinehydrochloride077inhealthysubjectswithasymptomaticeyesdatafrom2independentclinicalstudies AT iyergr pharmacokineticsandsafetyofolopatadinehydrochloride077inhealthysubjectswithasymptomaticeyesdatafrom2independentclinicalstudies AT dubinerhb pharmacokineticsandsafetyofolopatadinehydrochloride077inhealthysubjectswithasymptomaticeyesdatafrom2independentclinicalstudies AT vutikullirda pharmacokineticsandsafetyofolopatadinehydrochloride077inhealthysubjectswithasymptomaticeyesdatafrom2independentclinicalstudies AT wirtad pharmacokineticsandsafetyofolopatadinehydrochloride077inhealthysubjectswithasymptomaticeyesdatafrom2independentclinicalstudies AT sallk pharmacokineticsandsafetyofolopatadinehydrochloride077inhealthysubjectswithasymptomaticeyesdatafrom2independentclinicalstudies
_version_	1718399969155612672

Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies

Ejemplares similares