臨床研究等提出・公開システム

Date of registration	Feb. 07, 2022
Last modified on	July. 03, 2024
Trial ID	jRCT2031210584

Scientific Title	SJP-0130 Phase 2 -Placebo Controlled Parallel Group Study in Primary Open Angle Glaucoma or Ocular Hypertention patients-
Public Title	Placebo Controlled Comparative Study of SJP-0130 in Primary Open Angle Glaucoma or Ocular Hypertention patients

Completion date	Dec. 20, 2022
Result actual enrolment	88
Baseline Characteristics	[sex] Male: 48 participants (54.5%), Female: 40 participants (45.5%) [a mean of age] 61.8 years [target disease] Primary Open Angle Glaucoma (Broad definition): 71 participants (80.7%), Ocular Hypertension: 17 participants (19.3%)
Participant flow	[Informed Consent] 90 participants [Randomized] 88 participants [Completed] 84 participants
Adverse events	There were no deaths or serious adverse events.
Outcome measures	Analysis showed a statistically significant difference between the SJP-0130 group and placebo group in mean change from baseline in intraocular pressure at the time of primary endpoint, in favor of active treatment.
Brief summary	SJP-0130 was a safe and effective treatment for Primary Open Angle Glaucoma or Ocular Hypertension patients.
Date of posting of results summaries	July. 03, 2024

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT2031210584

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		Feb. 10, 2022
Actual date of first enrollment		Feb. 28, 2022
Target sample size		75
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 20 years or older and less than 75 years at the time of the informed consent - Male or non-childbearing potential female patients - Have been diagnosed with primary open angle glaucoma or ocular hypertension - Meet the other protocol-specified inclusion criteria
	Exclusion Criteria	- Received treatment of glaucoma other than eye drops in eye - Received surgery or laser therapy in eye - Have ophthalmic disease other than primary open angle glaucoma or ocular hypertention - Have known history of hypersensitivity or serious adverse reaction to any of the study drug ingredients - Have advanced visual field disorder - Have eye abnomalitites that interfere with accurate measurement of ocular pressure - Have judged that it is inappropriate to participate in this study by investigator - Meet the other protocol-specified exclusion criteria
	Age Minimum	20age old over
	Age Maximum	75age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Glaucoma / Oular hypertension
Intervention(s)		Administration of SJP-0130 or placebo
Primary Outcome(s)		Efficacy and safety

Primary Sponsor	Senju Pharmaceutical Co., Ltd.

Secondary Sponsor

Name of Certified Review Board	Medical Corporation Shintokai Yokohama Minoru Clinic Institutional Review Board
Address	1-13-8, Bessho, Minami-Ku, Yokohama-City Kanagawa, Kanagawa
Telephone	+81-42-648-5551
E-Mail	yminoru-irb@epsogo.co.jp
Approval Status	Approval
Date of approval	Feb. 10, 2022

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	July. 03, 2024	(this page)	Changes
5	Dec. 27, 2022	Detail	Changes
4	June. 01, 2022	Detail	Changes
3	April. 07, 2022	Detail	Changes
2	Mar. 17, 2022	Detail	Changes
1	Feb. 07, 2022	Detail

List of change history