臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 18, 2025
Last modified on	Mar. 26, 2025
Trial ID	jRCT2031240688

Scientific Title	Observer -masked comparative study of STN1014003 ophthalmic solution and latanoprost ophthalmic solution in patients with open-angle glaucoma/ocular hypertension and open-label long-term study -Phase III-
Public Title	STN1014003 ophthalmic solution in patients with open-angle glaucoma/ocular hypertension phase III study

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	Recruiting

Anticipated date of first enrollment		Feb. 18, 2025
Actual date of first enrollment		Mar. 26, 2025
Target sample size		230
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- 18 years of age or older. - Diagnosis of OAG or OHT in both eyes - Best corrected visual acuity (BCVA) in any eye is 0.20 or better in decimal visual acuity - Willingness and ability to give signed informed consent and follow study instructions
	Exclusion Criteria	- Clinically significant ocular disease - History of angle closure glaucoma, or narrow angles - Previous glaucoma intraocular surgery - 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	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		open angle glaucoma (OAG) or ocular hypertension (OHT)
Intervention(s)		Single masked treatment period - STN1014003 Arm:1 drop STN1014003 once daily - Latanoprost Arm:1 drop 0.005% Latanoprost once daily Open-label treatment period - 1 drop STN1014003 once daily
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	General Incorporated Association Nihon Hospital Alliance (NHA) Central Institutional Review Board
Address	5-34-7 Shiba Minato-ku, Tokyo
Telephone	+81-3-6779-8166
E-Mail	chi-pr-irb-nha-a@cmicgroup.com
Approval Status	Approval
Date of approval	Jan. 24, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)	なし
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Mar. 26, 2025	(this page)	Changes
1	Feb. 18, 2025	Detail

List of change history