Actively Recruiting

Phase 3
Age: 5Years - 10Years
All Genders
NCT07329777

Atropine in the Treatment of Myopia Study in Malaysia

Led by IDB VisionCare SDN BHD · Updated on 2026-01-09

144

Participants Needed

2

Research Sites

206 weeks

Total Duration

On this page

Sponsors

I

IDB VisionCare SDN BHD

Lead Sponsor

S

Singapore National Eye Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Atropine in the Treatment of Myopia Study in Malaysia

Who Can Participate

Age: 5Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female children between 5 to 10 years of age.
  • Refractive error of spherical equivalent between -1.00 D and -6.00 D in each eye.
  • Active myopia progression of at least -0.50 D spherical equivalent within the last 12 months.
  • Astigmatism less than -1.50 D.
  • Distance vision correctable to logMAR 0.2 or better in both eyes.
  • Difference between non-cycloplegic and cycloplegic subjective spherical refraction not greater than -1.00 D.
  • Normal intraocular pressure not greater than 21 mmHg in either eye.
  • Normal ocular health except for myopia.
  • Good general health with no history of cardiac or respiratory diseases affecting study treatment or follow-ups.
  • No asthma-requiring medications in the past one year.
  • No known allergy to atropine, cyclopentolate, proparacaine, or benzalkonium chloride.
  • Willing and able to comply with scheduled visits and study procedures.
  • Written informed consent from parent and assent from child obtained.
Not Eligible

You will not qualify if you...

  • History of hypersensitivity or allergy to study drug or ingredients.
  • Prior or current use of other myopia control drugs, contact lenses, or spectacles except normal or tinted/anti-glare glasses.
  • Congenital myopia.
  • Use of Ortho K or myopia lenses.
  • Ocular or systemic diseases affecting vision or refractive error.
  • Any ocular condition contraindicating topical atropine.
  • Defective binocular function or stereopsis.
  • Amblyopia (lazy eye) or manifest strabismus including intermittent tropia.
  • Previous or current use of atropine or pirenzepine.
  • Conditions preventing adherence to protocol including unwillingness to avoid other myopia control treatments during study.
  • Any condition risking participant safety or study results per investigator judgment.
  • Participation in any clinical study within 30 days before randomization.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hospital Pakar Kanak-Kanak UKM

Kuala Lumpur, Cheras, Malaysia, 56000

Actively Recruiting

2

Universiti Malaya Medical Centre

Kuala Lumpur, Petaling Jaya, Malaysia, 50603

Actively Recruiting

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Research Team

N

Nor Syakirah Zainal

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Atropine in the Treatment of Myopia Study in Malaysia | DecenTrialz