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.

NCT07329777 Phase 3 RECRUITING

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.

Details

Lead sponsor	IDB VisionCare SDN BHD
Phase	Phase 3
Status	RECRUITING
Enrolment	144
Start date	2025-09-17
Completion	2029-09

Conditions

• Myopia Progression

Interventions

• Low dose atropine sulfate eye drops
• Placebo

Primary outcomes

• To demonstrate the superiority of eye drop formulation (Atropine Sulphate 0.025% w/v Eye Drops) against placebo determined by Spherical equivalent — 12 months
  Spherical equivalent refraction determined by cycloplegic autorefraction from baseline to 12 months at each visit.

Countries

Malaysia