臨床研究等提出・公開システム

Scientific Title	A phase 2a, randomized, evaluator-masked, placebo-controlled, parallel-group, multicenter study assessing the efficacy and safety of STN1013400 ophthalmic solution in subjects with mild or moderate myopia
Public Title	A Phase 2a Study assessing the efficacy and safety of STN1013400 ophthalmic solution in patients with myopia

Contact for Scientific Queries	Name	Migita Yukie
	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	Migita Yukie
	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	Not Recruiting

Anticipated date of first enrollment		May. 15, 2023
Actual date of first enrollment		May. 22, 2023
Target sample size		67
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Written informed consent from legally acceptable representative and assent from subject have been obtained. Cycloplegic objective spherical equivalent -1.0 to -6.0 D (-1.0 <=X<= -6.0) in both eyes. Patients with progressive myopia on refractive examination.
	Exclusion Criteria	Patients who previously receive treatments for reducing myopia progression. Patients who are inappropriate as participants in this study in the opinion of the investigator or sub-investigator.
	Age Minimum	6age old over
	Age Maximum	11age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Myopia
Intervention(s)		High dose STN1013400 ophthalmic solution, low dose STN1013400 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	Santen pharmaceutical co.,ltd

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Medical Corporation TOUKEIKAI Kitamachi Clinic IRB
Address	1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-0001,Japan, Tokyo
Telephone	+81-3-6779-8166
E-Mail	chi-pr-cirb-kitamachi@cmicgroup.com
Approval Status	Approval
Date of approval	April. 19, 2023

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