Evaluating Two Low-dose Atropine Sulfate Eye Drops (0.01% and 0.02%) for Slowing Myopia Progression in Children and Adolescents in a Randomized, Placebo-controlled Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two low-dose atropine sulfate eye drops (0.01% and 0.02%) in delaying the progression of myopia in children and adolescents aged 6 to 12 years. This Phase III, randomized, double-blind, placebo-controlled study aims to compare these treatments to placebo over a 96-week period, with additional exploratory objectives to assess longer-term efficacy and possible rebound effects after stopping treatment. Participants will be randomly assigned to receive either 0.01% atropine sulfate eye drops, 0.02% atropine sulfate eye drops, or placebo eye drops. Each treatment involves applying one drop in each eye every night before sleep, followed by gently pressing the tear duct area on both sides for about one minute. The study will monitor participants throughout the treatment period and may include extended observation for up to 144 weeks to explore longer-term outcomes. During the study, children will attend regular visits for assessments including measurement of eye refraction under cycloplegia to evaluate changes in myopia. Researchers will also monitor safety and any side effects throughout the treatment. The primary outcome is the change from baseline in equivalent spherical refraction at the Week 96 visit. Participants will be required to comply with study visits and procedures, including telephone follow-ups, to support data collection and safety monitoring over the course of the trial.

The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression