臨床研究等提出・公開システム

Date of registration	Sept. 26, 2024
Last modified on	Sept. 03, 2025
Trial ID	jRCT2031240352

Scientific Title	Phase 3 a long-term administration study of NTa53 in Patients with Allergic Conjunctivitis
Public Title	Phase 3 a long-term administration study of NTa53

Contact for Scientific 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
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	Complete

Anticipated date of first enrollment		Sept. 16, 2024
Actual date of first enrollment		Oct. 07, 2024
Target sample size		120
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single 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	7age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Allergic Conjunctivitis
Intervention(s)		56-day Administration of NTa53
Primary Outcome(s)		Safety (Adverse Events, Ophthalmologic Examination and Clinical Examination) Efficacy (Subjective Ocular Symptom Score, Objective Ocular Findings Score, Quality Of Life Survey)

Primary Sponsor	Nitto Medic Co., Ltd.

Secondary Sponsor

Name of Certified Review Board	Medical Corporation Sinanokai Shinanozaka Clinic Institutional Review Board
Address	Yotsuya Medical Building 3F, 20 Samoncho, Shinjuku-ku, Tokyo
Telephone	+81-3-5366-3006
E-Mail	scl-irb@shinanokai.com
Approval Status	Approval
Date of approval	Sept. 10, 2024

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29 Miyahara, Yodogawa-ku, Osaka City, Tokyo
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status	Approval
Date of approval	Sept. 10, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Sept. 03, 2025	(this page)	Changes
3	Mar. 13, 2025	Detail	Changes
2	Oct. 15, 2024	Detail	Changes
1	Sept. 26, 2024	Detail

List of change history