A comparative confirmatory study of STN1013800 in subjects with Acquired Blepharoptosis

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220394

Enrollment

324

Registered

2022-10-19

Start date

2022-10-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Blepharoptosis

Interventions

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)

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

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

Contacts

Public ContactOka Koji

Santen pharmaceutical co.,ltd

clinical@santen.co.jp+81-6-4802-9341

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026