Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients

Hideki Miyake,1 Yuri Kawano,2 Hiroshi Tanaka,2 Akihiro Iwata,3 Takahiro Imanaka,1 Masatsugu Nakamura1 1Ophthalmic Disease Area Strategy Department, 2Clinical Operations Department, 3Data Science Department, R&D Division, Santen Pharmaceutical Co., Ltd. Osaka, Japan Purpose: We aimed to eva...

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Autores principales:	Miyake H, Kawano Y, Tanaka H, Iwata A, Imanaka T, Nakamura M
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	Schirmer diquafosol tear dry eye multicenter Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/c8026ab943454dd183be008f7fc2ff2c
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spelling	oai:doaj.org-article:c8026ab943454dd183be008f7fc2ff2c2021-12-02T03:26:38ZTear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients1177-5483https://doaj.org/article/c8026ab943454dd183be008f7fc2ff2c2016-05-01T00:00:00Zhttps://www.dovepress.com/tear-volume-estimation-using-a-modified-schirmer-test-a-randomized-mul-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Hideki Miyake,1 Yuri Kawano,2 Hiroshi Tanaka,2 Akihiro Iwata,3 Takahiro Imanaka,1 Masatsugu Nakamura1 1Ophthalmic Disease Area Strategy Department, 2Clinical Operations Department, 3Data Science Department, R&D Division, Santen Pharmaceutical Co., Ltd. Osaka, Japan Purpose: We aimed to evaluate the feasibility of using a modified Schirmer test to determine the increase in tear volume after administration of 3% diquafosol ophthalmic solution (diquafosol 3%) in dry eye patients. Patients and methods: A randomized, multicenter, prospective, double-blind clinical study recruited 50 qualified subjects. They received diquafosol 3% in one eye and artificial tears in the other eye. The study protocol comprised a screening and treatment procedure completed within 1 day. The Schirmer test was performed on closed eyes three times a day. The primary efficacy end points were the second Schirmer test scores 10 minutes after the single dose. Secondary end points were the third Schirmer test scores 3 hours and 40 minutes after the single dose and the symptom scores prior to the second and third Schirmer tests. Results: According to the Schirmer test, 10 minutes after administration, diquafosol 3% significantly increased tear volume compared to artificial tears. Diquafosol 3% and artificial tears both showed significant improvements in the symptom scores compared to baseline. However, there was no significant difference in the symptoms score between diquafosol 3% and artificial tears. Conclusion: The modified Schirmer test can detect a minute change in tear volume in dry eye patients. These findings will be useful in the diagnosis of dry eye, assessment of treatment benefits in daily clinical practice, and the development of possible tear-secreting compounds for dry eye. Keywords: P2Y2, efficacy, Diquas®Miyake HKawano YTanaka HIwata AImanaka TNakamura MDove Medical PressarticleSchirmerdiquafosolteardry eyemulticenterOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2016, Iss Issue 1, Pp 879-886 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	Schirmer diquafosol tear dry eye multicenter Ophthalmology RE1-994
spellingShingle	Schirmer diquafosol tear dry eye multicenter Ophthalmology RE1-994 Miyake H Kawano Y Tanaka H Iwata A Imanaka T Nakamura M Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients
description	Hideki Miyake,1 Yuri Kawano,2 Hiroshi Tanaka,2 Akihiro Iwata,3 Takahiro Imanaka,1 Masatsugu Nakamura1 1Ophthalmic Disease Area Strategy Department, 2Clinical Operations Department, 3Data Science Department, R&D Division, Santen Pharmaceutical Co., Ltd. Osaka, Japan Purpose: We aimed to evaluate the feasibility of using a modified Schirmer test to determine the increase in tear volume after administration of 3% diquafosol ophthalmic solution (diquafosol 3%) in dry eye patients. Patients and methods: A randomized, multicenter, prospective, double-blind clinical study recruited 50 qualified subjects. They received diquafosol 3% in one eye and artificial tears in the other eye. The study protocol comprised a screening and treatment procedure completed within 1 day. The Schirmer test was performed on closed eyes three times a day. The primary efficacy end points were the second Schirmer test scores 10 minutes after the single dose. Secondary end points were the third Schirmer test scores 3 hours and 40 minutes after the single dose and the symptom scores prior to the second and third Schirmer tests. Results: According to the Schirmer test, 10 minutes after administration, diquafosol 3% significantly increased tear volume compared to artificial tears. Diquafosol 3% and artificial tears both showed significant improvements in the symptom scores compared to baseline. However, there was no significant difference in the symptoms score between diquafosol 3% and artificial tears. Conclusion: The modified Schirmer test can detect a minute change in tear volume in dry eye patients. These findings will be useful in the diagnosis of dry eye, assessment of treatment benefits in daily clinical practice, and the development of possible tear-secreting compounds for dry eye. Keywords: P2Y2, efficacy, Diquas®
format	article
author	Miyake H Kawano Y Tanaka H Iwata A Imanaka T Nakamura M
author_facet	Miyake H Kawano Y Tanaka H Iwata A Imanaka T Nakamura M
author_sort	Miyake H
title	Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients
title_short	Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients
title_full	Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients
title_fullStr	Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients
title_full_unstemmed	Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients
title_sort	tear volume estimation using a modified schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/c8026ab943454dd183be008f7fc2ff2c
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Tear volume estimation using a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol ophthalmic solution and artificial tears in dry eye patients

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