臨床研究等提出・公開システム

Scientific Title	Phase 3 confirmatory study of K-911 (bimatoprost grenod) in patients with primary open-angle glaucoma (broad definition) or ocular hypertension
Public Title	K-911 Phese 3 confirmatory 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		Aug. 01, 2025
Actual date of first enrollment
Target sample size		500
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	Patients with POAG (board definition) 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 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), OH
Intervention(s)		K-911 ophthalmic solution 0.1% or latanoprost ophthalmic solution 0.005% 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 at 2, 4 and 6 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 at 2, 4 and 6 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

No	Publication date
2	July. 30, 2025	(this page)	Changes
1	June. 20, 2025	Detail

List of change history