臨床研究等提出・公開システム

Scientific Title	Phase 3 Allergen Challenge Trial of NTa53 in Patients with Allergic Conjunctivitis
Public Title	Phase 3 Conjunctival Allergen Challenge Trial of NTa53

Contact for Scientific Queries	Name	Hasunuma Tomoko
	Affiliation	Kitasato University Kitasato Institute Hospital
	Address	5-9-1 Shirokane,Minato-ku, Tokyo, Japan
	Telephone	+81-3-5791-6350
	E-mail	t-hasu@insti.kitasato-u.ac.jp
Contact for Public Queries	Name	Yonemichi Takeshi
	Affiliation	Nitto Medic Co., Ltd.
	Address	1-14-1 Yasuuchi, Yatsuo-machi, Toyama-city, Toyama, Japan
	Telephone	+81-76-455-3541
	E-mail	clinical@nittomedic.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 30, 2024
Actual date of first enrollment		Oct. 30, 2024
Target sample size		44
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	crossover 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. -Other protocol-specified exclusion criteria may apply.
	Age Minimum	12age old over
	Age Maximum	65age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Allergic Conjunctivitis
Intervention(s)		NTa53, active drug and placebo administration, and allergen challenge
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Efficacy (Ocular Itching Score and Conjunctival Redness Score)
Secondary Outcome(s)

Primary Sponsor	Nitto Medic 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
Telephone	+81-3-5791-6177
E-Mail	irb-pt@insti.kitasato-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 17, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Nov. 06, 2024	(this page)	Changes
1	Sept. 26, 2024	Detail

List of change history