Low-dose atropine eye drops to slow myopia in children

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.

This tests whether nightly 0.025% atropine eye drops slow worsening of myopia in children aged 5 to 10 compared with placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 5 Years to 10 Years
• Sex: All
• Sponsor: IDB VisionCare SDN BHD (Industry-sponsored)
• Locations: 2 sites (Kuala Lumpur, Cheras and 1 other locations)
• Trial ID: NCT07329777 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled Phase 3 study compares nightly 0.025% atropine eye drops with a placebo in children showing recent myopia progression. Eligible participants are 5–10 years old with spherical equivalent between -1.00 D and -6.00 D and documented progression of at least -0.50 D in the past year. The trial will monitor changes in refractive error and eye axial length over scheduled visits and will track safety measures such as intraocular pressure and adverse events. The study is run at specialist eye centers in Malaysia with oversight for pediatric safety and adherence.

Who should consider this trial

Good fit: Children aged 5–10 with myopia between -1.00 D and -6.00 D, documented recent progression (≥ -0.50 D in 12 months), astigmatism < -1.50 D, correctable vision to logMAR 0.2 or better, normal eye health and intraocular pressure, and no history of asthma medication use in the past year or known atropine allergy.

Not a fit: Children outside the refractive/age ranges, with significant ocular disease, high astigmatism, recent asthma requiring medication, known allergy to atropine, or other medical conditions that prevent safe use may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this could slow childhood myopia progression and reduce the long-term risk of high myopia and its sight-threatening complications.

How similar studies have performed: Previous randomized trials (for example ATOM and LAMP programs) have shown that low-dose atropine can slow myopia progression, though the best concentration and long-term outcomes continue to be refined.

Eligibility criteria

Inclusion Criteria:

1. Male or female children between 5 to 10 years of age.
2. Children with refractive error of spherical equivalent -1.00 D up to -6.00 D in each eye.
3. Children with active myopia progression of at least spherical equivalent -0.50 D within the last 12 months.
4. Children with astigmatism of less than -1.50 D
5. Children having distance vision correctable to logMAR 0.2 or better in both eyes.
6. A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D.
7. Children with normal intraocular pressure of not greater than 21 mmHg in either eye.
8. Children with normal ocular health other than myopia.
9. 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.
10. No asthma-requiring medications in the past one year.
11. No known allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride.
12. Willing and able to comply with scheduled visits and other study procedures.
13. Written Informed Consent from parent and assent from child has been obtained.

Exclusion Criteria:

1. History of hypersensitivity or allergy to study drug and/or any of the study medication ingredients.
2. 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.
3. Children with congenital myopia.
4. Children using Ortho K and Myopia Lens.
5. Children with ocular or systemic diseases which may affect vision or refractive error.
6. Children with any ocular condition wherein topical atropine is contraindicated.
7. Children with defective binocular function or stereopsis.
8. Children with amblyopia (lazy eyes) or manifest strabismus including intermittent tropia.
9. Previous or current use of atropine or pirenzepine.
10. 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.
11. Children with any other condition which may put the subject to risk during study or affect study results based on investigator's judgement.
12. Children participated in any clinical study within 30 days prior to randomization.

Where this trial is running

Kuala Lumpur, Cheras and 1 other locations

• Hospital Pakar Kanak-Kanak UKM — Kuala Lumpur, Cheras, Malaysia (Recruiting)
• Universiti Malaya Medical Centre — Kuala Lumpur, Petaling Jaya, Malaysia (Recruiting)

Study contacts

• Study coordinator: Nor Syakirah Zainal

Conditions Myopia Progression