NCT06514612

LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis.

A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) Used Twice Daily (BID) in the Treatment of Acquired Blepharoptosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (estimated)
• Sponsor: Santen SAS · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis

Detailed description

This is a randomised, double-masked, placebo-controlled Phase 3 study of the safety and efficacy of STN1013800 in the treatment of acquired blepharoptosis. Subjects diagnosed with acquired blepharoptosis who meet eligibility criteria at Visit 1 (Screening) will return within 8 days for Visit 2 (Baseline, Day 1). At Visit 2 (Baseline, Day 1) they will be randomised to receive double-masked treatment for 6 weeks, with study visits completed at Week 2 (Day 14) and Week 6 (Day 42), and a post-treatment visit completed 2 weeks (± 3 days) after last study drug administration. Approximately 234 adult subjects with blepharoptosis who meet all the eligibility criteria will be randomised in a 1:1 ratio to receive: * STN1013800 BID * Placebo BID Note that: * On study visits Day 1 and Day 42, the AM dose is administered at 08:00 (at site) and the PM dose is administered at 16:00 (self-administered at home) * On study visit Day 14, the AM dose is administered at 06:00 (self-administered at home), the PM dose is administered at 14:00 (at site)

Conditions

• Acquired Blepharophimosis

Interventions

Type	Name	Description
DRUG	STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers	STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers
OTHER	Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers	Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-07-23
• Last updated: 2025-03-20

Locations

37 sites across 9 countries: Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom