臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 19, 2022
Last modified on	June. 10, 2024
Trial ID	jRCT2031220394

Scientific Title	A Phase III, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Superiority of STN1013800 Ophthalmic Solution 0.1% Compared with Placebo Ophthalmic Solution in Subjects with Acquired Blepharoptosis
Public Title	A comparative confirmatory study of STN1013800 in subjects with Acquired Blepharoptosis

Contact for Scientific Queries	Name	Koji Oka
	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	Koji Oka
	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	Complete

Anticipated date of first enrollment		Oct. 11, 2022
Actual date of first enrollment		Oct. 19, 2022
Target sample size		324
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	18 years old or older and younger than 75 years old At least one eye diagnosed with acquired blepharoptosis was 2mm or less in MRD-1 Corrected visual acuity of 0.1 or better
	Exclusion Criteria	With cutis laxa Have congenital ptosis Have Horner syndrome Have Marcus Gunn jaw-winking syndrome With mechanical blepharoptosis Having a history of blepharoptosis surgery Females who are pregnant, nursing, or planning a pregnancy. Diseases judged to be ineligible for safety (e.g., severe cardiovascular, respiratory, hepatobiliary, gastrointestinal, urology, renal, hematological, endocrine, immune, malignancy) Abuse or dependence of alcohol or drugs
	Age Minimum	18age old over
	Age Maximum	75age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Acquired Blepharoptosis
Intervention(s)		STN1013800 ophthalmic solution 0.1% (1 drop at a time, once daily) STN1013800 ophthalmic solution 0.1% (1 drop at a time, twice daily) Placebo ophthalmic solution (1 drop at a time, twice daily)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Change in MRD-1 (Marginal Reflex Distance-1) from the first day of treatment after 14 days of treatment
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	ShinAkasaka Clinic IRB
Address	5-5-1, Roppongi, Minato-ku, Tokyo, Tokyo
Telephone	+81-3-5770-1250
E-Mail	irb-shinakasaka@sin-akasaka.com
Approval Status	Approval
Date of approval	Aug. 25, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	June. 10, 2024	(this page)	Changes
2	Oct. 27, 2022	Detail	Changes
1	Oct. 19, 2022	Detail

List of change history