臨床研究等提出・公開システム

Date of registration	Mar. 13, 2026
Last modified on	June. 09, 2026
Trial ID	jRCT2031250810

Scientific Title	A clinical trial of STN1014101 ophthalmic solution in healthy adult male volunteers and allergic conjunctivitis patients for single and repeated dose - Phase I/IIa, clinical pharmacology study, exploratory study -
Public Title	A phase I/IIa study of STN1014101 ophthalmic solution in healthy adult male volunteers and allergic conjunctivitis patients

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		April. 01, 2026
Actual date of first enrollment		June. 09, 2026
Target sample size		64
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	- 18 to 65 years of age - Male or Female - Has a positive result for from a Type I allergy test.
	Exclusion Criteria	- Eye disease other than allergic conjunctivitis is present and requires treatment. - Females who are pregnant, nursing or planning a pregnancy, or anyone of childbearing potential who are not using a reliable method of contraception. - Anyone otherwise considered unsuitable for the study by the investigators
	Age Minimum	18age old over
	Age Maximum	65age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Allergic Conjunctivitis
Intervention(s)		Instill either STN1014101 ophthalmic solution, placebo ophthalmic solution, or Alesion LX 0.1% ophthalmic solution once daily or twice daily, followed by allergen provocation.
Primary Outcome(s)		Safety, Efficacy (Subjective Ocular Symptom Score and Objective Findings Score)

Primary Sponsor	Santen pharmaceutical co.,ltd

Secondary Sponsor

Name of Certified Review Board	The IRB of Kitasato University Shirokane Campus
Address	5-9-1, Shirokane, Minato-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-5791-6177
E-Mail	irb-pt@insti.kitasato-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 25, 2026

Plan to share IPD	No

Secondary ID(s)	なし

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 09, 2026	(this page)	Changes
1	Mar. 13, 2026	Detail

List of change history