Low-dose atropine eye drops to slow myopia in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: atommy@idbvisioncare.com
• Phone: +60143213786

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.