臨床研究等提出・公開システム

Scientific Title	Phase 3 long-term study of K-911 (bimatoprost grenod) in patients with primary open-angle glaucoma (broad definition), exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
Public Title	K-911 phase 3 long-term study

Contact for Scientific Queries	Name	Tanigawa Ryohei
	Affiliation	Kowa Company, Ltd.
	Address	4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo
	Telephone	+81-3-3279-7454
	E-mail	ctrdinfo@kowa.co.jp
Contact for Public Queries	Name	Contact for clinical trial information
	Affiliation	Kowa Company, Ltd.
	Address	4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo
	Telephone	+81-3-3279-7454
	E-mail	ctrdinfo@kowa.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 01, 2025
Actual date of first enrollment
Target sample size		120
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with POAG (board definition) , exfoliation glaucoma, pigmentary glaucoma or OH
	Exclusion Criteria	(1)Patients in whom the best-corrected visual acuity is <0.3 (2)Patients who are expected to undergo the following treatments during the study period. 1)Use of anti-glaucoma/anti-OH drugs(excluding for beta-blockers used in accordance with regulations.) 2)Use of contact lenses.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		POAG(broad definition), exfoliation glaucoma, pigmentary glaucoma, OH
Intervention(s)		K-911 ophthalmic solution 0.1% administered topically When using a beta-blocker, beta-blocker ophthalmic solution administered topically
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Efficacy:Changes from baseline in intraocular pressure after 2 week (at 16:00) Safety:Presence or absence of adverse events and side effects
Secondary Outcome(s)		Efficacy Percent changes from baseline in intraocular pressure after 2 week (at 16:00)

Primary Sponsor	Kowa Company, Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29 Miyahara,Yodogawa-ku,Osaka-shi,Osaka 532-0003 JAPAN, Osaka
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status
Date of approval	June. 19, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history