臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 23, 2020
Last modified on	April. 25, 2022
Trial ID	jRCT2031200243

Scientific Title	SJP-0132 Phase 2 - A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study in Participants with Dry Eye Disease -
Public Title	Placebo-Controlled, Parallel-Group Study of SJP-0132 in Participants with Dry Eye Disease

Contact for Scientific Queries	Name	Omatsu Kazunori
	Affiliation	Senju Pharmaceutical Co., Ltd.
	Address	6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-777-1018
	E-mail	senju-clinicaltrials@senju.co.jp
Contact for Public Queries	Name	Clinical development division
	Affiliation	Senju Pharmaceutical Co., Ltd.
	Address	6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-777-1018
	E-mail	senju-clinicaltrials@senju.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 24, 2020
Actual date of first enrollment		Dec. 25, 2020
Target sample size		332
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Have a continuous subjective symptoms of Dry Eye Disease - Tear film break-up time of <= 5 seconds - Have a fluorescein staining in the cornea - 20 years and older at the time of Informed Consent
	Exclusion Criteria	- Contact lens wearers who cannot discontinue the wear over the trial period - Have clinically active ophthalmic disease other than Dry Eye Disease - Have a known hypersensitivity or history of serious adverse reaction to any of the study drug ingredients - Have a history of, or scheduled corneal transplantation during the study - Have a history of, or scheduled permanent punctal occlusion during the study - Have used or anticipates use of a punctal plug during the study - Cannot discontinue any ophthalmic, nasal, or complementary medicines during the study - Have a history of, or scheduled eye surgery during the study - Pregnant, potentially pregnant, or lactating
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Dry Eye Desease
Intervention(s)		Administer SJP-0132 or placebo to participants with dry eye disease
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Change from baseline in corneal fluorescein staining score
Secondary Outcome(s)

Primary Sponsor	Senju Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	ShinAkasaka Clinic Institutional Review Board
Address	Roppongi Roi Bldg. 11F, 5-5-1, Roppongi, Minato-ku, Tokyo
Telephone	+81-3-5770-1250
E-Mail	irb@sinakasaka.com
Approval Status	Approval
Date of approval	Dec. 10, 2020

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
8	April. 25, 2022	(this page)	Changes
7	April. 07, 2022	Detail	Changes
6	July. 16, 2021	Detail	Changes
5	April. 12, 2021	Detail	Changes
4	Mar. 03, 2021	Detail	Changes
3	Jan. 29, 2021	Detail	Changes
2	Jan. 13, 2021	Detail	Changes
1	Dec. 23, 2020	Detail

List of change history