Atropine in the Treatment of Myopia Study in Malaysia (ATOM-MY)

December 29, 2025 updated by: IDB VisionCare SDN BHD

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Malaysia
    • Cheras
      • Kuala Lumpur, Cheras, Malaysia, 56000
        • Recruiting
        • Hospital Pakar Kanak-Kanak UKM
        • Contact:
    • Petaling Jaya
      • Kuala Lumpur, Petaling Jaya, Malaysia, 50603
        • Recruiting
        • Universiti Malaya Medical Centre
        • Contact:
          • Prof. Dr. Nurliza binti Khaliddin
          • Phone Number: +60 3-79492060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Drug: Low dose atropine sulfate eye drops
Atropine Sulphate 0.025% w/v Eye Drops
Placebo Comparator: 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.
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To demonstrate the superiority of eye drop formulation (Atropine Sulphate 0.025% w/v Eye Drops) against placebo determined by Spherical equivalent
Time Frame: 12 months
Spherical equivalent refraction determined by cycloplegic autorefraction from baseline to 12 months at each visit.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To demonstrate continued efficacy of eye drop formulation (Atropine Sulphate 0.025% w/v Eye Drops) of 24 months with the comparison of 12 months by spherical equivalent
Time Frame: 24 months
Determination of rate of progression in year 2 vs year 1 via Spherical equivalent refraction as determined by cycloplegic autorefraction of 24 months with the comparison of 12 months.
24 months
To demonstrate the superiority of eye drop formulation (Atropine Sulpahte 0.025% w/v Eye Drops) against placebo by axial length
Time Frame: 12 months
Axial length as determined by non-contact partial coherence interferometry from baseline to 12 months at each visit.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IDB VisionCare SDN BHD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Singapore National Eye Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT01-ATOM-MY-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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