Phase III Study Evaluating the Safety and Effectiveness of 0.1% STN1013800 Eye Drops for Treating Acquired Blepharoptosis in Chinese Adults

What this Trial Is About

Researchers are evaluating the efficacy and safety of a new drug called STN1013800 ophthalmic solution for treating acquired blepharoptosis in Chinese patients. This condition involves drooping of the upper eyelid, and currently, there are no approved medicines for this in China. This is a Phase III randomized, double-masked, placebo-controlled study designed to compare STN1013800 with a placebo solution. Participants will receive either 0.1% STN1013800 ophthalmic solution or a placebo once daily for 42 days, based on prior clinical trial results. The study includes a screening period lasting 3 to 7 days to confirm eligibility. The interventions involve applying the assigned eye drops daily, with the study treatment and placebo groups monitored in parallel. During the study, participants will undergo multiple assessments including margin reflex distance-1 MRD-1 measurements and Leicester Peripheral Field Test LPFT scores at several time points Day 1 Hour 6, Day 14 Hour 2, and Day 42. Researchers will track changes from baseline in eyelid position and visual function to evaluate treatment effects. Safety and adherence will also be monitored throughout the 42-day treatment period.

A Study in Chinese Patients With Acquired Blepharoptosis