Myopia ProgressionPhase 3ATOM-MYNCT07329777
Atropine in the Treatment of Myopia Study in Malaysia
A Phase 3 study testing Low dose atropine sulfate eye drops in people with Myopia Progression, run by IDB VisionCare SDN BHD at 2 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Myopia Progression
- What is being tested?
- Low dose atropine sulfate eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesMalaysia
- Study dates
- 17 Sep 2025to Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female children between 5 to 10 years of age.
- Children with refractive error of spherical equivalent -1.00 D up to -6.00 D in each eye.
- Children with active myopia progression of at least spherical equivalent -0.50 D within the last 12 months.
- Children with astigmatism of less than -1.50 D
- Children having distance vision correctable to logMAR 0.2 or better in both eyes.
- A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D.
Show all 13Show fewer
- Children with normal intraocular pressure of not greater than 21 mmHg in either eye.
- Children with normal ocular health other than myopia.
- 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.
- No asthma-requiring medications in the past one year.
- No known allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride.
- Willing and able to comply with scheduled visits and other study procedures.
- Written Informed Consent from parent and assent from child has been obtained.
Who cannot join
- History of hypersensitivity or allergy to study drug and/or any of the study medication ingredients.
- 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.
- Children with congenital myopia.
- Children using Ortho K and Myopia Lens.
- Children with ocular or systemic diseases which may affect vision or refractive error.
- Children with any ocular condition wherein topical atropine is contraindicated.
Show all 12Show fewer
- Children with defective binocular function or stereopsis.
- Children with amblyopia (lazy eyes) or manifest strabismus including intermittent tropia.
- Previous or current use of atropine or pirenzepine.
- 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.
- Children with any other condition which may put the subject to risk during study or affect study results based on investigator's judgement.
- Children participated in any clinical study within 30 days prior to randomization.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia2 sites, 2 recruiting
- Recruiting
Hospital Pakar Kanak-Kanak UKM
Kuala Lumpur, Cheras, 56000
Associate Prof. Dr Safinaz Mohd Khialdin, +603-91455981, drsafinaz_1978@yahoo.com.my
- Recruiting
Universiti Malaya Medical Centre
Kuala Lumpur, Petaling Jaya, 50603
Prof. Dr. Nurliza binti Khaliddin, +60 3-79492060
About this study
Official title: 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.
Read the 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
- Being tested
- Low dose atropine sulfate eye drops, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose atropine sulfate eye dropsDrug
Atropine Sulphate 0.025% w/v Eye Drops
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Atropine Sulphate 0.025% w/v Eye Drops | Active comparator | 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. Receives: Drug: Low dose atropine sulfate eye drops |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the superiority of eye drop formulation (Atropine Sulphate 0.025% w/v Eye Drops) against placebo determined by Spherical equivalent
Spherical equivalent refraction determined by cycloplegic autorefraction from baseline to 12 months at each visit.
Measured: 12 months
Secondary outcomes (2)
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
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.
Measured: 24 months
To demonstrate the superiority of eye drop formulation (Atropine Sulpahte 0.025% w/v Eye Drops) against placebo by axial length
Axial length as determined by non-contact partial coherence interferometry from baseline to 12 months at each visit.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start17 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia ProgressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDB VisionCare SDN BHD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Singapore National Eye Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329777
- Sponsor's protocol ID
- CT01-ATOM-MY-2022
- Acronym
- ATOM-MY
- Status last verified
- Dec 2025
- First submitted
- 16 Sep 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07329777
- Acronym / sponsor ID
- ATOM-MY / CT01-ATOM-MY-2022
- Conditions
- Myopia Progression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- IDB VisionCare SDN BHDIndustry (pharma, biotech, devices)
- Collaborators
- Singapore National Eye Centre
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine Sulphate 0.025% w/v Eye Drops | Active comparator | Drug: Low dose atropine sulfate eye dropsParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Male or female children between 5 to 10 years of age.
- Children with refractive error of spherical equivalent -1.00 D up to -6.00 D in each eye.
- Children with active myopia progression of at least spherical equivalent -0.50 D within the last 12 months.
- Children with astigmatism of less than -1.50 D
- Children having distance vision correctable to logMAR 0.2 or better in both eyes.
Key exclusion criteria (12 listed)
- History of hypersensitivity or allergy to study drug and/or any of the study medication ingredients.
- 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.
- Children with congenital myopia.
- Children using Ortho K and Myopia Lens.
- Children with ocular or systemic diseases which may affect vision or refractive error.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose atropine sulfate eye dropsAtropine Sulphate 0.025% w/v Eye Drops | Drug | Atropine Sulphate 0.025% w/v Eye Drops |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Myopia Progression
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Recruiting
Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses
Myopia, Myopia Progression
Active, not recruiting
Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities
Refractive Errors
Recruiting
Children's Viewing Behavior
Myopia, Myopia Progression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low dose atropine sulfate eye drops in people with Myopia Progression, run by IDB VisionCare SDN BHD at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nor Syakirah Zainal (+60143213786, atommy@idbvisioncare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.