臨床研究等提出・公開システム

Scientific Title	A Phase 2a, Randomized, Evaluator-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1010905 Ophthalmic Suspension Compared with Placebo in Subjects with MGD
Public Title	A phase 2a study assessing the efficacy and safety of STN1010905 ophthalmic suspension in subjects with MGD

Contact for Scientific Queries	Name	Migita Yukie
	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	Migita Yukie
	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		June. 17, 2024
Actual date of first enrollment		July. 01, 2024
Target sample size		120
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	- Outpatient - Diagnosed as MGD based on the guideline - Having ocular symptoms
	Exclusion Criteria	- Ocular disease which needs treatment expect MGD and dry eye - Requires contact lenses wear during the study - Any decision by the Investigator to terminate a subject in screening
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		MGD (Meibomian Gland Dysfunction)
Intervention(s)		- Screening period : Artificial tear (BID, Both eyes) - Treatment period : High dose STN1010905 ophthalmic suspension, Low dose STN1010905 ophthalmic suspension or Placebo (BID, Both eyes)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Evaluation of meibomian gland by idra
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
Telephone	+81-3-3881-6116
E-Mail	c-irb_ug@neues.co.jp
Approval Status	Approval
Date of approval	April. 25, 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	July. 03, 2024	(this page)	Changes
1	June. 18, 2024	Detail

List of change history