臨床研究等提出・公開システム

Japanese

Date of registration	Nov. 17, 2025
Last modified on	Dec. 22, 2025
Trial ID	jRCT2031250504

Scientific Title	A Multicenter, Randomized, Evaluator -Masked, Placebo-Controlled, Parallel-Group Study of STN1014200 Ophthalmic Emulsions in Patients with Pterygium
Public Title	A Phase II Study of STN1014200 in Subjects with Pterygium

Contact for Scientific Queries	Name	Inai Maya
	Affiliation	Santen pharmaceutical co.,ltd
	Address	4-20 Ofuka-cho, Kita-ku, Osaka, Japan
	Telephone	81-6-4802-9341
	E-mail	clinical@santen.co.jp
Contact for Public Queries	Name	Inai Maya
	Affiliation	Santen pharmaceutical co.,ltd
	Address	4-20 Ofuka-cho, Kita-ku, Osaka, Japan
	Telephone	81-6-4802-9341
	E-mail	clinical@santen.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 15, 2025
Actual date of first enrollment		Dec. 22, 2025
Target sample size		126
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	- 18 years of age or older - Outpatient status - Diagnosed with pterygium (excluding recurrent pterygium) in at least one eye
	Exclusion Criteria	- Presence of active ocular infection or conjunctivitis in either eye (excluding mild blepharitis not requiring pharmacological treatment) - History of herpetic eye disease in either eye - History of pseudopterygium, marginal corneal disease, ocular neoplasms (including non-invasive carcinoma, squamous cell carcinoma, or other tumorous conditions), or chemical/thermal ocular burns in either eye - Pregnant, breastfeeding, possibly pregnant (including positive pregnancy test), planning to become pregnant during the study period, or unwilling to use at least one of the specified contraceptive methods from informed consent through the end of the study - Determined by the investigator or sub-investigator to be unsuitable for participation in this study based on medical history, physical examination findings, clinical laboratory results, or other background information
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		pterygium (excluding recurrent pterygium)
Intervention(s)		- 0.1% STN1014200 ophthalmic emulsion group: One drop twice daily (morning and evening) instilled into the eligible eye(s) - 0.2% STN1014200 ophthalmic emulsion group: One drop twice daily (morning and evening) instilled into the eligible eye(s) - STN1014200 placebo ophthalmic emulsion group: One drop twice daily (morning and evening) instilled into the eligible eye(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Percent change in the pterygium lesion length from baseline to Month 6
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	Adachikyousai Hospital Institutional Review Board
Address	1-36-8, Yanagihara, Adachi-ku, Tokyo, Tokyo
Telephone	+81-3-3881-6116
E-Mail	c-irb_ug@neues.co.jp
Approval Status	Approval
Date of approval	Oct. 09, 2025

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	Dec. 22, 2025	(this page)	Changes
1	Nov. 17, 2025	Detail

List of change history