臨床研究等提出・公開システム

Scientific Title	Open-Label Long-Term Study of 0.5% STN1011402 ophthalmic cream in Patients with Allergic Conjunctivitis -phase 3 study-
Public Title	Phase 3 Study of STN1011402 ophthalmic cream in Patients With Allergic Conjunctivitis

Contact for Scientific Queries	Name	Kayoko Sakamoto
	Affiliation	Santen pharmaceutical co.,ltd
	Address	4-20 Ofuka-cho, Kita-ku, Osaka, Japan
	Telephone	+81-648029341
	E-mail	clinical@santen.co.jp
Contact for Public Queries	Name	Kayoko Sakamoto
	Affiliation	Santen pharmaceutical co.,ltd
	Address	4-20 Ofuka-cho, Kita-ku, Osaka, Japan
	Telephone	+81-648029341
	E-mail	clinical@santen.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 22, 2022
Actual date of first enrollment		Mar. 08, 2022
Target sample size		180
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Provided signed, written informed consent. Has a positive result 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 females of childbearing potential who are not using a reliable method of contraception.
	Age Minimum	12age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Allergic Conjunctivitis
Intervention(s)		0.5% STN1011402 ophthalmic cream (30mg/time, once a day) or 0.1% Epinastine hydrochloride ophthalmic solution (1 drop/time, twice a day) will be applied for 8 weeks.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety, Efficacy(Subjective Ocular Symptom Score)
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 Sinanokai Shinanozaka Clinic Institutional Review Board
Address	20 Samoncho, Shinjuku-ku, Tokyo, Tokyo
Telephone	+81-3-5366-3006
E-Mail	scl-irb@shinanokai.com
Approval Status	Approval
Date of approval	Jan. 25, 2022

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