NCT06683651

A Study in Chinese Patients With Acquired Blepharoptosis

A Multicenter, Randomized, Double-Masked, Placebo-Controlled Parallel Group Phase III Study to Evaluate the Efficacy and Safety of STN1013800 Ophthalmic Solution in Chinese Patients With Acquired Blepharoptosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Santen Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III Study to evaluate the efficacy and safety of STN1013800 Ophthalmic Solution in Chinese Patients with Acquired Blepharoptosis. At present, there are no medicines for the treatment of acquired blepharoptosis in China. Therefore, to evaluate the efficacy and safety of 0.1% STN1013800 ophthalmic solution, Vehicle (Placebo) are designed. For the screening period, 3-7 days were set to confirm the subjects and judge their qualification. Dosage and administration were based on prior clinical trial results approved at 0.1% once daily for 42 days treatment.

Conditions

• Blepharoptosis

Interventions

Type	Name	Description
DRUG	STN1013800 ophthalmic solution	Investigational Product: 0.1% STN1013800 ophthalmic solution
DRUG	STN1013800 ophthalmic solution Liquid Base, without STN1013800	Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800

Timeline

• Start date: 2024-10-22
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

21 sites across 1 country: China