A comparative confirmatory study of STN1013800 in subjects with Acquired Blepharoptosis

Completed

• Conditions: Acquired Blepharoptosis

• Registration Number: jRCT2031220394
• Lead Sponsor: Santen pharmaceutical co.,ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-19
• Study First Submitted: 2022-10-19
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
MRD-1 (Marginal Reflex Distance-1)	14 days of treatment	Change in MRD-1 (Marginal Reflex Distance-1) from the first day of treatment after 14 days of treatment