臨床研究等提出・公開システム

Scientific Title	A clinical trial of STN1014100 ophthalmic solution in healthy adult male volunteers and dry eye patients for single and repeated dose - Phase I/IIa, clinical pharmacology study, exploratory study -
Public Title	A phase I/IIa study of STN1014100 ophthalmic solution in healthy adult male volunteers and dry eye patients

Contact for Scientific Queries	Name	Koji Oka
	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	Koji Oka
	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	Complete

Anticipated date of first enrollment		Jan. 10, 2023
Actual date of first enrollment		Jan. 20, 2023
Target sample size		134
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 as having dry eye
	Exclusion Criteria	- Any corneal and conjunctival abnormalities or other diseases other than dry eye affecting the ocular surface - Having eye disease requiring treatment other than dry eye. - Anatomically and functionally abnormal eyelids (e.g. Eyelid closure failure) - Anyone otherwise considered unsuitable for the study by the investigators
	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, 1 drop, once daily Group 2: STN1014100 or placebo, 1 drop, twice daily Group 3: Diquas LX 3%,1 drop, three times daily
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety, Pharmacokinetics, Efficacy (Tear fluid secretion)
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 Heishinkai OPHAC Hospital IRB
Address	4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka, Osaka
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status	Approval
Date of approval	Dec. 08, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)	なし
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history