臨床研究等提出・公開システム

Japanese

Date of registration	May. 31, 2021
Last modified on	Feb. 17, 2023
Trial ID	jRCT2031210122

Scientific Title	A Phase 3, double-masked, randomized, multi-center, placebo-controlled, parallel-group, 4-week study evaluating the efficacy and safety of 0.02% STN1013900 ophthalmic solution compared to its vehicle under concomitant use of Latanoprost ophthalmic solution 0.005% in subjects with primary open angle glaucoma or ocular hypertension
Public Title	Efficacy and Safety Study of 0.002% STN1013900 ophthalmic solution under concomitant use of Latanoprost ophthalmic solution 0.005% in subjects with primary open angle glaucoma or ocular hypertension

Contact for Scientific Queries	Name	Sakamoto Kayoko
	Affiliation	Santen pharmaceutical co.,ltd
	Address	4-20 Ofuka-cho, Kita-ku, Osaka, Japan
	Telephone	+81-6-4802-9341
	E-mail	clinical@santen.co.jp
Contact for Public Queries	Name	Sakamoto Kayoko
	Affiliation	Santen pharmaceutical co.,ltd
	Address	4-20 Ofuka-cho, Kita-ku, Osaka, Japan
	Telephone	+81-6-4802-9341
	E-mail	clinical@santen.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 25, 2021
Actual date of first enrollment		July. 08, 2021
Target sample size		234
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	20 years of age or older Diagnosis of POAG or OHT in both eyes Best-corrected visual acuity (BCVA) +0.7 log MAR or better (>= 20/100 Snellen or >= 0.20 in decimal unit) in each eye Willingness and ability to give signed informed consent and follow study instructions
	Exclusion Criteria	Ophthalmic: Clinically significant ocular disease Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles Previous glaucoma intraocular surgery Refractive surgery in either eye Ocular trauma Ocular infection Any corneal disease Known hypersensitivity to any component of the study drugs, or to topical anesthetic Systemic: Clinically significant systemic disease Participation in any investigational study within 30 days prior to screening Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		primary open angle glaucoma (POAG) or ocular hypertension (OHT)
Intervention(s)		STN1013900 Arm: 1 drop 0.02% STN1013900 once daily and 1 drop 0.005% Latanoprost Vehicle Arm: 1 drop vehicle once daily and 1 drop 0.005% Latanoprost
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Mean diurnal IOP at Week 4
Secondary Outcome(s)

Primary Sponsor	Santen pharmaceutical co.,ltd

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	ShinAkasaka Clinic IRB
Address	5-5-1, Roppongi, Minato-ku , Tokyo
Telephone	+81-3-5770-1250
E-Mail	irb-shinakasaka@sin-akasaka.com
Approval Status	Approval
Date of approval	April. 22, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Feb. 17, 2023	(this page)	Changes
3	Aug. 27, 2021	Detail	Changes
2	July. 09, 2021	Detail	Changes
1	May. 31, 2021	Detail

List of change history