臨床研究等提出・公開システム

Scientific Title	ROH-001 ophthalmic solution phase II clinical trial in patients with myopia
Public Title	ROH-001 ophthalmic solution phase II clinical trial in patients with myopia

Contact for Scientific Queries	Name	Mantani Tomomi
	Affiliation	ROHTO Pharmaceutical Co., Ltd.
	Address	6-5-4, Kunimidai, Kizugawa, Kyoto 619-0216, Japan
	Telephone	+81-774-71-8802
	E-mail	rohtocl@rohto.co.jp
Contact for Public Queries	Name	Mantani Tomomi
	Affiliation	ROHTO Pharmaceutical Co., Ltd.
	Address	6-5-4, Kunimidai, Kizugawa, Kyoto 619-0216, Japan
	Telephone	+81-774-71-8802
	E-mail	rohtocl@rohto.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 18, 2025
Actual date of first enrollment
Target sample size		210
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	Written informed consent from subjects guardian or legally acceptable representative have been obtained Cycloplegic objective spherical equivalent <=-1.50 D, >-6.00 D in both eyes Patients with progressive myopia
	Exclusion Criteria	Patients who previously receive treatments for slowing myopia progression. Patients who the principal/sub investigator has determined are not suitable to participate in this study
	Age Minimum	6age old over
	Age Maximum	15age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Myopia
Intervention(s)		ROH-001 ophthalmic solution or placebo
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		The change in objective spherical equivalent
Secondary Outcome(s)

Primary Sponsor	ROHTO Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	IRB administrated by General incorporated association of ethic committee for clinical trials
Address	2-12-13, Shinjuku, Shinjuku-ku, Tokyo
Telephone	+81-3-5050-4268
E-Mail	information@centriol-one.com
Approval Status	Approval
Date of approval	April. 01, 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	April. 28, 2025	(this page)	Changes
1	April. 18, 2025	Detail

List of change history