Phase 3 Study of STN1013800 Oxymetazoline 0.1% Eye Drops Used Twice Daily for Treating Acquired Blepharoptosis in Adults

What this Trial Is About

The trial investigates the safety and effectiveness of STN1013800 Oxymetazoline HCl 0.1% eye drops used twice daily in adults with acquired blepharoptosis, a condition where the upper eyelid droops. This randomized, double-masked, placebo-controlled Phase 3 study aims to evaluate how well the study drug works compared to placebo in improving eyelid position. Participants diagnosed with acquired blepharoptosis will be randomly assigned to receive either STN1013800 eye drops or placebo, both administered twice daily for 6 weeks. Dosing occurs at specific times on Days 1 and 42, the morning dose is given at the study site and the evening dose at home on Day 14, the morning dose is self-administered at home and the evening dose at the site. After the 6-week treatment, a follow-up visit occurs two weeks after the last dose. During the study, participants will have scheduled visits at screening, baseline Day 1, Week 2 Day 14, Week 6 Day 42, and a post-treatment visit two weeks later. Researchers will assess changes in eyelid position using Marginal Reflex Distance MRD1 and measure patient-reported outcomes about change impressions. Safety and adherence to treatment will also be monitored throughout the trial period, which lasts about 8 weeks including follow-up.

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.