A comparative confirmatory study of STN1013800 in subjects with Acquired Blepharoptosis

JRCT ID: jRCT2031220394

Registered date:19/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acquired Blepharoptosis
• Date of first enrollment: 19/10/2022
• Target sample size: 324
• 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• 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