Safety and Effectiveness of Low-dose 0.01% and 0.02% Atropine Eye Drops to Slow Myopia in Children Ages 6 to 12

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two low-dose atropine sulfate eye drops 0.01% and 0.02% in slowing the progression of myopia in children and adolescents aged 6 to 12 years. This randomized, double-blind, placebo-controlled Phase III trial aims to compare these treatments against a placebo over 96 weeks, with an exploratory period extending to 144 weeks to assess long-term effects and potential rebound after stopping treatment. Participants receive either 0.01% atropine, 0.02% atropine, or placebo eye drops, applying one drop in each eye every night before sleep. Each application is followed by gently pressing the tear duct area on both sides for about one minute. The study includes a 96-week treatment period with evaluations and an optional extended follow-up to monitor sustained treatment effects and safety. Throughout the study, children will attend regular visits for eye exams measuring changes in vision and eye length. Researchers will assess the degree of myopia progression and safety at 12 and 24 months, including tests of refraction and ocular morphology. Careful monitoring ensures adherence to treatment and tracks any side effects, with the primary outcome being the change in spherical refraction after 96 weeks.

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