臨床研究等提出・公開システム

Japanese

Date of registration	May. 15, 2025
Last modified on	May. 15, 2025
Trial ID	jRCT2031250103

Scientific Title	SJP-0049 Phase 2 -A Single-Center, Single-Masked, Randomized, Placebo-Controlled, Parallel-Group Comparative Study in Patients with Allergic Conjunctivitis-
Public Title	Placebo Controlled, Parallel-Group Study of SJP-0049 in Patients with Allergic Conjunctivitis

Contact for Scientific Queries	Name	Omatsu Kazunori
	Affiliation	Senju Pharmaceutical Co., Ltd.
	Address	6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-777-1018
	E-mail	senju-clinicaltrials@senju.co.jp
Contact for Public Queries	Name	Clinical development division
	Affiliation	Senju Pharmaceutical Co., Ltd.
	Address	6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo
	Telephone	+81-78-777-1018
	E-mail	senju-clinicaltrials@senju.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 22, 2025
Actual date of first enrollment
Target sample size		112
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	Aged 18 years or older at the time of Informed Consent (any gender) Live in Japan Have a history of allergic conjunctivitis. Meet the other protocol-specified inclusion criteria
	Exclusion Criteria	-Need to wear contact lens during the study -Have a history of ocular surgery during the period specified in protocol, or scheduled surgery during the study -Have a history of punctal occlusion during the period specified in protocol, or schedule during the study -Have participated in another clinical trial and received investigational drug during the period specified in protocol, or scheduled during the study -Have a use of prohibited concomitant medications during the period specified in protocol, or unable to discontinue using or anticipate using during the study -Have active ophthalmic disease other than allergic conjunctivitis -Have known history of hypersensitivity to any of the study drug ingredients -Pregnant, potentially pregnant, lactating or intending to become pregnant. Unable to obtain a consent to practice adequate contraception during the study -Unable to obtain a consent to practice adequate contraception and not to donate sperm during the study -Have judged that it is inappropriate to participate in this study by investigator -Meet the other protocol-specified exclusion criteria
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Allergic Conjunctivitis
Intervention(s)		Ocular administration of SJP-0049, Placebo, or reference drug
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Subjective ocular symptom score
Secondary Outcome(s)		-Subjective ocular symptom score and objective ocular findings score -Safety

Primary Sponsor	Senju 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 108-8642 Japan, Tokyo
Telephone	+81-3-5791-6177
E-Mail	irb-jim@kitasato-u.ac.jp
Approval Status
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none