臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 14, 2023
Last modified on	July. 09, 2024
Trial ID	jRCT2031230312

Scientific Title	SJP-0135 Phase 3 -A Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel-Group Study in Patients with Primary Open Angle Glaucoma or Ocular Hypertension
Public Title	Active-Controlled, Parallel-Group Study of SJP-0135 in Patients with Primary Open Angle Glaucoma or Ocular Hypertension

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		Sept. 15, 2023
Actual date of first enrollment
Target sample size		140
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-Aged 18 years or older at the time of Informed Consent (any gender) -Have been diagnosed with primary open angle glaucoma or ocular hypertension -Meet the other protocol-specified inclusion criteria
	Exclusion Criteria	-Have a history of, or scheduled ocular surgery/laser therapy during the study -Unable to discontinue wearing contact lens during the study -Have active ocular disease other than primary open angle glaucoma or ocular hypertension -Have severe visual field disorders -Have abnormalities that interfere with measurement of intraocular pressure -Have severe systemic illness -Have a history of hypersensitivity or serious adverse reaction to any of the drugs used in the study -Pregnant, lactating, or potentially pregnant -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		Primary open angle glaucoma or Ocular hypertension
Intervention(s)		Eye administration of SJP-0135 or brimonidine tartrate/ timolol maleate combination ophthalmic solution
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Efficacy
Secondary Outcome(s)		Efficacy and 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	ShinAkasaka Clinic Aoyama Institutional Review Board
Address	Hulic Aoyama Gaien Higashi-dori Building. 2F, 2-2-3, Minamiaoyama, Minato-ku, Tokyo, 107-0062, Japan, Tokyo
Telephone	+81-3-5770-1250
E-Mail	irb@sinakasaka.com
Approval Status	Not approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	July. 09, 2024	(this page)	Changes
2	Mar. 12, 2024	Detail	Changes
1	Sept. 14, 2023	Detail

List of change history