臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 15, 2022
Last modified on	June. 04, 2024
Trial ID	jRCT2031220497

Scientific Title	SJP-0132 Phase 3 - Multicenter, Randomized, Double-Masked, Placebo Controlled, Parallel-Group Study in Patients with Dry Eye Disease -
Public Title	Placebo Controlled, Parallel-Group Study of SJP-0132 in Patients 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. 19, 2022
Actual date of first enrollment		Jan. 19, 2023
Target sample size		498
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	- Aged over 18 years at the time of the informed consent(any gender) - Live in Japan - Have continuous subjective symptoms of dry eye disease - Tear film break-up time of <= 5 seconds - Meet the other protocol-specified inclusion criteria may apply
	Exclusion Criteria	- Unable to discontinue wearing contact lens during the study - 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 - Have a history of, or scheduled ocular surface surgery during the study - Have ophthalmic disease other than dry eye disease - Have disease that affects subjective symptoms of dry eye - Have known history of hypersensitivity or serious adverse reaction to any of the study drug ingredients - Unable to discontinue any ophthalmic medicines including OTC, except test drug for ophthalmic examination during the study - Female participant who is pregnant, potentially pregnant, lactating or intents to become pregnant. And unable to obtain a consent to practice adequate contraception during the study - Male participant who does not agree to practice adequate contraception and not to donate sperm during the study - Have judged that it is inappropriate to participate in this study by investigator - Meet the other protocol-specified exclusion criteria
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Dry Eye Disease
Intervention(s)		Administer SJP-0132 or Placebo as an eye drop 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 dry eye symptoms
Secondary Outcome(s)		- Dry eye signs and symptoms - Safety

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	Shin-Akasaka Clinic Aoyama Institutional Review Board
Address	Hulic Aoyama Gaien Higashidori Bldg. 2F, 2-2-3, Minamiaoyama, Minato-ku, Tokyo, 107-0062 Japan, Tokyo
Telephone	+81-3-5770-1250
E-Mail	irb@sinakasaka.com
Approval Status	Approval
Date of approval	Nov. 10, 2022

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	June. 04, 2024	(this page)	Changes
7	Sept. 29, 2023	Detail	Changes
6	Aug. 12, 2023	Detail	Changes
5	June. 24, 2023	Detail	Changes
4	April. 29, 2023	Detail	Changes
3	Mar. 25, 2023	Detail	Changes
2	Feb. 01, 2023	Detail	Changes
1	Dec. 15, 2022	Detail

List of change history