Atropine in the Treatment of Myopia Study in Malaysia

NCT ID: NCT07329777

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-17
• Study Completion Date: 2029-09-30

Brief 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.

Detailed Description

Myopia represents the most prevalent refractive error globally, with its incidence rising significantly over recent decades, particularly in East Asian populations. Current projections estimate that by the year 2050, nearly 50% of the global population will be affected by myopia, with approximately 10% classified as high myopes. High myopia is characterized by axial elongation of the eye and is associated with an elevated risk of severe ocular complications, including early-onset cataracts, glaucoma, retinal detachment, choroidal neovascularization, myopic macular degeneration, and macular hemorrhage. Given its increasing prevalence and potential for vision-threatening outcomes, myopia constitutes a substantial public health issue, contributing to considerable healthcare and socioeconomic burdens. Therefore, the development of safe and effective interventions to mitigate the progression of myopia is of critical importance.

Conditions

Myopia Progression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Atropine Sulphate 0.025% w/v Eye Drops

Participants will be instructed to administer one drop of Atropine Sulphate 0.025% w/v Eye Drops into each eye once daily at bedtime for a duration of 24 months.

Group Type: ACTIVE_COMPARATOR

Low dose atropine sulfate eye drops

Intervention Type: DRUG

Atropine Sulphate 0.025% w/v Eye Drops

Placebo

Participants will be instructed to administer one drop of Placebo Eye Drops into each eye once daily at bedtime for a duration of 12 months and Atropine Sulphate 0.025% w/v Eye Drops from 13-24 months onwards.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Low dose atropine sulfate eye drops

Atropine Sulphate 0.025% w/v Eye Drops

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Singapore National Eye Centre

OTHER_GOV

Sponsor Role: collaborator

IDB VisionCare SDN BHD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Pakar Kanak-Kanak UKM

Kuala Lumpur, Cheras, Malaysia

Site Status: RECRUITING

Universiti Malaya Medical Centre

Kuala Lumpur, Petaling Jaya, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Nor Syakirah Zainal

Role: CONTACT

atommy@idbvisioncare.com

+60143213786

Facility Contacts

Associate Prof. Dr Safinaz Mohd Khialdin

Role: primary

drsafinaz_1978@yahoo.com.my

+603-91455981

Prof. Dr. Nurliza binti Khaliddin

Role: primary

+60 3-79492060

Other Identifiers

CT01-ATOM-MY-2022

Identifier Type: -

Identifier Source: org_study_id