臨床研究等提出・公開システム

Scientific Title	A Phase IIb, double-masked, randomized, multi-center, placebo-controlled, parallel-group study of STN1014100 ophthalmic solution in patients with dry eye
Public Title	A Phase IIb study of STN1014100 ophthalmic solution in patients with dry eye

Contact for Scientific Queries	Name	Oka Koji
	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	Oka Koji
	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	Recruiting

Anticipated date of first enrollment		May. 16, 2025
Actual date of first enrollment		May. 30, 2025
Target sample size		400
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	- 18 years of age or older - Male or Female - Both eyes diagnosed with dry eye
	Exclusion Criteria	- Any corneal and conjunctival abnormalities or other diseases other than dry eye affecting the ocular surface - Having any eye disease requiring treatment other than dry eye. -Anatomically and functionally abnormal eyelids (e.g. Eyelid closure failure) -The principal investigator or a sub-investigator judges it inappropriate as the subject of this clinical trial.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Dry eye
Intervention(s)		Group 1: STN1014100 or placebo, 1 drop, once daily Group 2: STN1014100 or placebo, 1 drop, twice daily
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Change from baseline in dry eye signs
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	IRB administrated by General incorporated association of ethic committee for clinical trials
Address	2-12-13, Shinjuku, Shinjuku-ku, Tokyo, Tokyo
Telephone	+81-3-5050-4268
E-Mail	information@centriol-one.com
Approval Status	Approval
Date of approval	April. 30, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)	なし
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	May. 30, 2025	(this page)	Changes
1	May. 16, 2025	Detail

List of change history