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.
IDB VisionCare SDN BHD
144 participants
Sep 17, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- Male or female children between 5 to 10 years of age.
- Children with refractive error of spherical equivalent -1.00 D up to -6.00 D in each eye.
- Children with active myopia progression of at least spherical equivalent -0.50 D within the last 12 months.
- Children with astigmatism of less than -1.50 D
- Children having distance vision correctable to logMAR 0.2 or better in both eyes.
- A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D.
- Children with normal intraocular pressure of not greater than 21 mmHg in either eye.
- Children with normal ocular health other than myopia.
- Children must be in good general health with no history of cardiac or respiratory diseases as per investigator's discretion and does not affect the study treatment or subsequent follow-ups.
- No asthma-requiring medications in the past one year.
- No known allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride.
- Willing and able to comply with scheduled visits and other study procedures.
- Written Informed Consent from parent and assent from child has been obtained.
Exclusion Criteria12
- History of hypersensitivity or allergy to study drug and/or any of the study medication ingredients.
- Children with prior and/or concomitant use of other myopia control drugs, contact lens or spectacles (except normal spectacles including tinted/anti-glare glasses) etc.
- Children with congenital myopia.
- Children using Ortho K and Myopia Lens.
- Children with ocular or systemic diseases which may affect vision or refractive error.
- Children with any ocular condition wherein topical atropine is contraindicated.
- Children with defective binocular function or stereopsis.
- Children with amblyopia (lazy eyes) or manifest strabismus including intermittent tropia.
- Previous or current use of atropine or pirenzepine.
- Children with any other conditions precluding adherence to the protocol including unwillingness to refrain from the use of other myopia control drug, contact lens or spectacles (except normal) spectacles including tinted/anti-glare glasses) etc. for the duration of the study.
- Children with any other condition which may put the subject to risk during study or affect study results based on investigator's judgement.
- Children participated in any clinical study within 30 days prior to randomization.
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Interventions
Atropine Sulphate 0.025% w/v Eye Drops
Placebo
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07329777