Preclinical Efficacy Comparison of Cyclosporine Ophthalmic Solution 0.09% vs Cyclosporine Ophthalmic Emulsion 0.05% vs Ciclosporin Ophthalmic Emulsion 0.1% in a NOD Mouse Model of Dry Eye Disease

Vinod Burade,1 Rishit Zalawadia,1 Alpesh Patel,1 Abayomi Ogundele2 1Sun Pharmaceutical Industries Limited, Vadodara, Gujarat, India; 2Sun Pharmaceutical Industries, Inc, Princeton, NJ, USACorrespondence: Abayomi OgundeleSun Pharmaceutical Industries, Inc, Princeton, NJ, USATel +1 (609) 720-5389Email...

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Autores principales:	Burade V, Zalawadia R, Patel A, Ogundele A
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	cyclosporine a goblet cell density keratoconjunctivitis sicca preclinical tear production Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/9be7161308bd4b1fbd04573111b37454
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spelling	oai:doaj.org-article:9be7161308bd4b1fbd04573111b374542021-12-02T08:55:54ZPreclinical Efficacy Comparison of Cyclosporine Ophthalmic Solution 0.09% vs Cyclosporine Ophthalmic Emulsion 0.05% vs Ciclosporin Ophthalmic Emulsion 0.1% in a NOD Mouse Model of Dry Eye Disease1177-5483https://doaj.org/article/9be7161308bd4b1fbd04573111b374542020-09-01T00:00:00Zhttps://www.dovepress.com/preclinical-efficacy-comparison-of-cyclosporine-ophthalmic-solution-00-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Vinod Burade,1 Rishit Zalawadia,1 Alpesh Patel,1 Abayomi Ogundele2 1Sun Pharmaceutical Industries Limited, Vadodara, Gujarat, India; 2Sun Pharmaceutical Industries, Inc, Princeton, NJ, USACorrespondence: Abayomi OgundeleSun Pharmaceutical Industries, Inc, Princeton, NJ, USATel +1 (609) 720-5389Email Abayomi.Ogundele@sunpharma.comIntroduction: Cyclosporine ophthalmic solution 0.09% (CsA 0.09% sol) is approved to increase tear production in patients with keratoconjunctivitis sicca. This study evaluated the efficacy of CsA 0.09% sol vs cyclosporine ophthalmic emulsion 0.05% (CsA 0.05% eml) vs ciclosporin ophthalmic emulsion 0.1% (CsA 0.1% eml) in a NOD mice model.Methods: Mice were randomized and administered placebo, CsA 0.09% sol twice daily, CsA 0.05% eml twice daily, CsA 0.09% sol once daily, or CsA 0.1% eml once daily in the conjunctival sac of both eyes for 60 days. Tear volume was measured with phenol red threads at baseline and 4 hours after treatment every 15 days. On day 58, the corneal surface was observed under a slit-lamp after staining with 3% lissamine green administered into the inferior lateral conjunctival sac. On day 61, mice were euthanized, globes excised, sliced into 4 μm sections in 3 areas per section, and stained. Total number of stained goblet cell/μm was counted, and the sum per eye was averaged. Lacrimal gland tissues were removed and interleukin (IL) 1-β cytokine levels estimated.Results: Groups comprised 11 mice each, including an untreated normal and untreated diseased control group (7 groups total). CsA 0.09% sol twice daily significantly increased tear volume on day 30, 45, and 60 vs CsA 0.05% eml (P< 0.05, < 0.001, < 0.001, respectively) and vs CsA 0.1% eml on day 60 (P< 0.05); CsA 0.09% sol once daily significantly increased tear volume on day 45 vs CsA 0.05% eml (P< 0.05). Goblet cell density significantly increased with CsA 0.09% sol twice daily vs placebo and NOD control (P< 0.01 both). There was no significant difference in corneal staining and IL-1β levels with CsA 0.09% sol.Conclusion: Sixty-day treatment with CsA 0.09% sol showed comparatively improved preclinical results vs CsA 0.05% eml and CsA 0.1% eml.Keywords: cyclosporine A, goblet cell density, keratoconjunctivitis sicca, preclinical, tear productionBurade VZalawadia RPatel AOgundele ADove Medical Pressarticlecyclosporine agoblet cell densitykeratoconjunctivitis siccapreclinicaltear productionOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 14, Pp 2747-2755 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	cyclosporine a goblet cell density keratoconjunctivitis sicca preclinical tear production Ophthalmology RE1-994
spellingShingle	cyclosporine a goblet cell density keratoconjunctivitis sicca preclinical tear production Ophthalmology RE1-994 Burade V Zalawadia R Patel A Ogundele A Preclinical Efficacy Comparison of Cyclosporine Ophthalmic Solution 0.09% vs Cyclosporine Ophthalmic Emulsion 0.05% vs Ciclosporin Ophthalmic Emulsion 0.1% in a NOD Mouse Model of Dry Eye Disease
description	Vinod Burade,1 Rishit Zalawadia,1 Alpesh Patel,1 Abayomi Ogundele2 1Sun Pharmaceutical Industries Limited, Vadodara, Gujarat, India; 2Sun Pharmaceutical Industries, Inc, Princeton, NJ, USACorrespondence: Abayomi OgundeleSun Pharmaceutical Industries, Inc, Princeton, NJ, USATel +1 (609) 720-5389Email Abayomi.Ogundele@sunpharma.comIntroduction: Cyclosporine ophthalmic solution 0.09% (CsA 0.09% sol) is approved to increase tear production in patients with keratoconjunctivitis sicca. This study evaluated the efficacy of CsA 0.09% sol vs cyclosporine ophthalmic emulsion 0.05% (CsA 0.05% eml) vs ciclosporin ophthalmic emulsion 0.1% (CsA 0.1% eml) in a NOD mice model.Methods: Mice were randomized and administered placebo, CsA 0.09% sol twice daily, CsA 0.05% eml twice daily, CsA 0.09% sol once daily, or CsA 0.1% eml once daily in the conjunctival sac of both eyes for 60 days. Tear volume was measured with phenol red threads at baseline and 4 hours after treatment every 15 days. On day 58, the corneal surface was observed under a slit-lamp after staining with 3% lissamine green administered into the inferior lateral conjunctival sac. On day 61, mice were euthanized, globes excised, sliced into 4 μm sections in 3 areas per section, and stained. Total number of stained goblet cell/μm was counted, and the sum per eye was averaged. Lacrimal gland tissues were removed and interleukin (IL) 1-β cytokine levels estimated.Results: Groups comprised 11 mice each, including an untreated normal and untreated diseased control group (7 groups total). CsA 0.09% sol twice daily significantly increased tear volume on day 30, 45, and 60 vs CsA 0.05% eml (P< 0.05, < 0.001, < 0.001, respectively) and vs CsA 0.1% eml on day 60 (P< 0.05); CsA 0.09% sol once daily significantly increased tear volume on day 45 vs CsA 0.05% eml (P< 0.05). Goblet cell density significantly increased with CsA 0.09% sol twice daily vs placebo and NOD control (P< 0.01 both). There was no significant difference in corneal staining and IL-1β levels with CsA 0.09% sol.Conclusion: Sixty-day treatment with CsA 0.09% sol showed comparatively improved preclinical results vs CsA 0.05% eml and CsA 0.1% eml.Keywords: cyclosporine A, goblet cell density, keratoconjunctivitis sicca, preclinical, tear production
format	article
author	Burade V Zalawadia R Patel A Ogundele A
author_facet	Burade V Zalawadia R Patel A Ogundele A
author_sort	Burade V
title	Preclinical Efficacy Comparison of Cyclosporine Ophthalmic Solution 0.09% vs Cyclosporine Ophthalmic Emulsion 0.05% vs Ciclosporin Ophthalmic Emulsion 0.1% in a NOD Mouse Model of Dry Eye Disease
title_short	Preclinical Efficacy Comparison of Cyclosporine Ophthalmic Solution 0.09% vs Cyclosporine Ophthalmic Emulsion 0.05% vs Ciclosporin Ophthalmic Emulsion 0.1% in a NOD Mouse Model of Dry Eye Disease
title_full	Preclinical Efficacy Comparison of Cyclosporine Ophthalmic Solution 0.09% vs Cyclosporine Ophthalmic Emulsion 0.05% vs Ciclosporin Ophthalmic Emulsion 0.1% in a NOD Mouse Model of Dry Eye Disease
title_fullStr	Preclinical Efficacy Comparison of Cyclosporine Ophthalmic Solution 0.09% vs Cyclosporine Ophthalmic Emulsion 0.05% vs Ciclosporin Ophthalmic Emulsion 0.1% in a NOD Mouse Model of Dry Eye Disease
title_full_unstemmed	Preclinical Efficacy Comparison of Cyclosporine Ophthalmic Solution 0.09% vs Cyclosporine Ophthalmic Emulsion 0.05% vs Ciclosporin Ophthalmic Emulsion 0.1% in a NOD Mouse Model of Dry Eye Disease
title_sort	preclinical efficacy comparison of cyclosporine ophthalmic solution 0.09% vs cyclosporine ophthalmic emulsion 0.05% vs ciclosporin ophthalmic emulsion 0.1% in a nod mouse model of dry eye disease
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/9be7161308bd4b1fbd04573111b37454
work_keys_str_mv	AT buradev preclinicalefficacycomparisonofcyclosporineophthalmicsolution009vscyclosporineophthalmicemulsion005vsciclosporinophthalmicemulsion01inanodmousemodelofdryeyedisease AT zalawadiar preclinicalefficacycomparisonofcyclosporineophthalmicsolution009vscyclosporineophthalmicemulsion005vsciclosporinophthalmicemulsion01inanodmousemodelofdryeyedisease AT patela preclinicalefficacycomparisonofcyclosporineophthalmicsolution009vscyclosporineophthalmicemulsion005vsciclosporinophthalmicemulsion01inanodmousemodelofdryeyedisease AT ogundelea preclinicalefficacycomparisonofcyclosporineophthalmicsolution009vscyclosporineophthalmicemulsion005vsciclosporinophthalmicemulsion01inanodmousemodelofdryeyedisease
_version_	1718398320290824192

Preclinical Efficacy Comparison of Cyclosporine Ophthalmic Solution 0.09% vs Cyclosporine Ophthalmic Emulsion 0.05% vs Ciclosporin Ophthalmic Emulsion 0.1% in a NOD Mouse Model of Dry Eye Disease

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