Evaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%

Jack V Greiner1,2, Kimberly Edwards-Swanson3, Avner Ingerman41Schepens Eye Research Institute, Boston, MA; 2Department of Ophthalmology, Harvard Medical School, Boston, MA; 3Johnson & Johnson Consumer and Personal Products Worldwide, Skillman, NJ; 4Ora Inc, Andover, MA, USAPurpose: To ev...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Jack V Greiner, Kimberly Edwards-Swanson, Avner Ingerman
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2011
Materias:
Acceso en línea:https://doaj.org/article/7260f238a8134aeba2dd95b1eca1b196
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:doaj.org-article:7260f238a8134aeba2dd95b1eca1b196
record_format dspace
spelling oai:doaj.org-article:7260f238a8134aeba2dd95b1eca1b1962021-12-02T02:48:29ZEvaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%1177-54671177-5483https://doaj.org/article/7260f238a8134aeba2dd95b1eca1b1962011-01-01T00:00:00Zhttp://www.dovepress.com/evaluation-of-alcaftadine-025-ophthalmic-solution-in-acute-allergic-co-a6061https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Jack V Greiner1,2, Kimberly Edwards-Swanson3, Avner Ingerman41Schepens Eye Research Institute, Boston, MA; 2Department of Ophthalmology, Harvard Medical School, Boston, MA; 3Johnson & Johnson Consumer and Personal Products Worldwide, Skillman, NJ; 4Ora Inc, Andover, MA, USAPurpose: To evaluate the effectiveness of alcaftadine 0.05%, 0.1%, and 0.25% ophthalmic solutions in treating the signs and symptoms of allergic conjunctivitis when compared with olopatadine hydrochloride 0.1% and placebo using the conjunctival allergen challenge (CAC) model.Methods: One hundred and seventy subjects were randomized and 164 subjects completed all visits. CAC was performed to determine and confirm subjects’ eligibility at visits 1 and 2, respectively. The CAC was repeated at visit 3 (day 0 ± 3), 16 hours after study medication instillation, and at visit 4 (day 14 ± 3), 15 minutes after instillation. Ocular itching and conjunctival redness were evaluated after an allergen challenge, along with several secondary endpoints.Results: Alcaftadine 0.25% and olopatadine 0.1% treatments exhibited significantly lower mean scores compared with placebo for ocular itching and conjunctival redness at visits 3 and 4. Most adverse events were self-limiting and mild in severity. No serious treatment-related adverse events occurred.Conclusion: Treatment with alcaftadine 0.25% ophthalmic solution resulted in mean differences of >1 unit (ocular itching) and approximately >1 unit (conjunctival redness), which was significant (P < 0.001) compared with placebo treatment. All doses of alcaftadine were safe and well tolerated in the population studied.Keywords: alcaftadine, allergic conjunctivitis, conjunctival allergen challenge Jack V GreinerKimberly Edwards-SwansonAvner IngermanDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2011, Iss default, Pp 87-93 (2011)
institution DOAJ
collection DOAJ
language EN
topic Ophthalmology
RE1-994
spellingShingle Ophthalmology
RE1-994
Jack V Greiner
Kimberly Edwards-Swanson
Avner Ingerman
Evaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%
description Jack V Greiner1,2, Kimberly Edwards-Swanson3, Avner Ingerman41Schepens Eye Research Institute, Boston, MA; 2Department of Ophthalmology, Harvard Medical School, Boston, MA; 3Johnson & Johnson Consumer and Personal Products Worldwide, Skillman, NJ; 4Ora Inc, Andover, MA, USAPurpose: To evaluate the effectiveness of alcaftadine 0.05%, 0.1%, and 0.25% ophthalmic solutions in treating the signs and symptoms of allergic conjunctivitis when compared with olopatadine hydrochloride 0.1% and placebo using the conjunctival allergen challenge (CAC) model.Methods: One hundred and seventy subjects were randomized and 164 subjects completed all visits. CAC was performed to determine and confirm subjects’ eligibility at visits 1 and 2, respectively. The CAC was repeated at visit 3 (day 0 ± 3), 16 hours after study medication instillation, and at visit 4 (day 14 ± 3), 15 minutes after instillation. Ocular itching and conjunctival redness were evaluated after an allergen challenge, along with several secondary endpoints.Results: Alcaftadine 0.25% and olopatadine 0.1% treatments exhibited significantly lower mean scores compared with placebo for ocular itching and conjunctival redness at visits 3 and 4. Most adverse events were self-limiting and mild in severity. No serious treatment-related adverse events occurred.Conclusion: Treatment with alcaftadine 0.25% ophthalmic solution resulted in mean differences of >1 unit (ocular itching) and approximately >1 unit (conjunctival redness), which was significant (P < 0.001) compared with placebo treatment. All doses of alcaftadine were safe and well tolerated in the population studied.Keywords: alcaftadine, allergic conjunctivitis, conjunctival allergen challenge
format article
author Jack V Greiner
Kimberly Edwards-Swanson
Avner Ingerman
author_facet Jack V Greiner
Kimberly Edwards-Swanson
Avner Ingerman
author_sort Jack V Greiner
title Evaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%
title_short Evaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%
title_full Evaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%
title_fullStr Evaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%
title_full_unstemmed Evaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%
title_sort evaluation of alcaftadine 0.25% ophthalmic solution in acute allergic conjunctivitis at 15 minutes and 16 hours after instillation versus placebo and olopatadine 0.1%
publisher Dove Medical Press
publishDate 2011
url https://doaj.org/article/7260f238a8134aeba2dd95b1eca1b196
work_keys_str_mv AT jackvgreiner evaluationofalcaftadine025ophthalmicsolutioninacuteallergicconjunctivitisat15minutesand16hoursafterinstillationversusplaceboandolopatadine01
AT kimberlyedwardsswanson evaluationofalcaftadine025ophthalmicsolutioninacuteallergicconjunctivitisat15minutesand16hoursafterinstillationversusplaceboandolopatadine01
AT avneringerman evaluationofalcaftadine025ophthalmicsolutioninacuteallergicconjunctivitisat15minutesand16hoursafterinstillationversusplaceboandolopatadine01
_version_ 1718402167110369280