臨床研究等提出・公開システム

Scientific Title	Double-masked, Comparison Study of 0.5% STN1011402 ophthalmic cream in Patients With Allergic Conjunctivitis - Phase 3 study, Confirmatory Study -
Public Title	Phase 3 Study of STN1011402 ophthalmic cream in Patients With Seasonal 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		May. 13, 2022
Actual date of first enrollment		June. 24, 2022
Target sample size		30
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	Provided signed, written informed consent. 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 females of childbearing potential who are not using a reliable method of contraception.
	Age Minimum	20age old over
	Age Maximum	65age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Allergic Conjunctivitis
Intervention(s)		First, 30 mg of 0.5% STN1011402 ophthalmic cream or placebo ophthalmic cream will be applied once a day, next, antigen will be induced 24 hours after its application.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Efficacy (Subjective Ocular Symptom Score and Objective Findings Score), Safety
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	The IRB of Kitasato University Shirokane Campus
Address	5-9-1, Shirokane, Minato-ku, Tokyo, Japan, Tokyo
Telephone	+81-357916177
E-Mail	irb-pt@insti.kitasato-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 23, 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