臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 12, 2022
Last modified on	Dec. 11, 2023
Trial ID	jRCT2031220267

Scientific Title	A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1012600 Ophthalmic Solution 0.002% Compared with Latanoprost 0.005% in Subjects with Primary Open Angle Glaucoma or Ocular Hypertension
Public Title	A comparative confirmatory study of STN1012600 in subjects with primary open angle glaucoma or ocular hypertension

Contact for Scientific Queries	Name	Koji Oka
	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	Koji Oka
	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		Aug. 09, 2022
Actual date of first enrollment		Aug. 23, 2022
Target sample size		300
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	18 years of age or older. Diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT. Corrected Visual Acuity of +0.60 logMAR (Decimal visual acuity 0.3) or better in each eye.
	Exclusion Criteria	Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye. History of severe ocular trauma in either eye. Any condition that prevents clear visualization of the fundus in either eye. Known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications. History of ocular surgery specifically intended to lower IOP in either eye. History of keratorefractive surgery in either eye. Females who are pregnant, nursing, or planning a pregnancy. Subjects with known or suspected drug or alcohol abuse. Participation in other investigational drugs or device clinical trials within 30 days prior to Screening. Any decision by the Investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.
	Age Minimum	18age 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)		STN1012600 0.002% Arm: 1 drop STN1012600 0.002% once daily Latanoprost 0.005% Arm: 1 drop Latanoprost 0.005% once daily
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Change from baseline in mean diurnal intraocular pressure 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, Tokyo
Telephone	+81-3-5770-1250
E-Mail	irb-shinakasaka@sin-akasaka.com
Approval Status	Approval
Date of approval	June. 30, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)	現在、取得中（取得後に入力）
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Dec. 11, 2023	(this page)	Changes
3	Feb. 12, 2023	Detail	Changes
2	Aug. 27, 2022	Detail	Changes
1	Aug. 12, 2022	Detail

List of change history