NCT07329777

Atropine in the Treatment of Myopia Study in Malaysia

Atropine in the Treatment of Myopia Study in Malaysia (ATOM-MY): A Randomized, Double-Blind Study to Demonstrate the Efficacy and Safety of Eye Drop Formulations (Atropine Sulphate 0.025 % w/v Eye Drops vs Placebo) in the Management of Controlling Progression of Myopia in Children.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: IDB VisionCare SDN BHD · Industry
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is designed to assess the efficacy and safety of Atropine Sulphate 0.025% w/v Eye Drops compared to placebo in a randomized, double-blind, placebo-controlled study for the management of myopia progression in children.

Detailed description

Myopia represents the most prevalent refractive error globally, with its incidence rising significantly over recent decades, particularly in East Asian populations. Current projections estimate that by the year 2050, nearly 50% of the global population will be affected by myopia, with approximately 10% classified as high myopes. High myopia is characterized by axial elongation of the eye and is associated with an elevated risk of severe ocular complications, including early-onset cataracts, glaucoma, retinal detachment, choroidal neovascularization, myopic macular degeneration, and macular hemorrhage. Given its increasing prevalence and potential for vision-threatening outcomes, myopia constitutes a substantial public health issue, contributing to considerable healthcare and socioeconomic burdens. Therefore, the development of safe and effective interventions to mitigate the progression of myopia is of critical importance.

Conditions

• Myopia Progression

Interventions

Type	Name	Description
DRUG	Low dose atropine sulfate eye drops	Atropine Sulphate 0.025% w/v Eye Drops
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-09-17
• Primary completion: 2027-09-01
• Completion: 2029-09-01
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

2 sites across 1 country: Malaysia