JRCT ID: jRCT2031220394
Registered date:19/10/2022
A comparative confirmatory study of STN1013800 in subjects with Acquired Blepharoptosis
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Acquired Blepharoptosis |
Date of first enrollment | 19/10/2022 |
Target sample size | 324 |
Countries of recruitment | |
Study type | Interventional |
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) |
Outcome(s)
Primary Outcome | Change in MRD-1 (Marginal Reflex Distance-1) from the first day of treatment after 14 days of treatment |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | < 75age old |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Koji Oka |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Oka Koji |
Address | 4-20 Ofuka-cho, Kita-ku, Osaka, Japan Osaka Japan 530-8552 |
Telephone | +81-6-4802-9341 |
clinical@santen.co.jp | |
Affiliation | Santen pharmaceutical co.,ltd |
Scientific contact | |
Name | Oka Koji |
Address | 4-20 Ofuka-cho, Kita-ku, Osaka, Japan Osaka Japan 530-8552 |
Telephone | +81-6-4802-9341 |
clinical@santen.co.jp | |
Affiliation | Santen pharmaceutical co.,ltd |