MyopiaPhase 3NCT03140358
The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
A Phase 3 study testing Atropine sulfate 0.01% in people with Myopia, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine sulfate 0.01%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 21 Apr 2017to 31 Dec 2025
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- One parent with myopia (<-3D in at least one eye)
- SE +1.00D to -1.50D
- Astigmatism < = 1.50D
- Distance vision logMAR 0.2 or better in both eyes
- Intraocular pressure of not greater than 21 mmHg
- No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride
Who cannot join
- Any eye or systemic disease that affect vision or refractive error
- Conditions where topical atropine contraindicated
- Previous use of atropine or pirenzepine
- Known past/current amblyopia or strabismus
Trial locations and contacts
1 site in 1 country.
About this study
Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.
Read the detailed description
High risk children (with family history of myopia) with low hyperopia or low myopia will be randomized to atropine or placebo, with 2 -2.5 year treatment and 1 year washout.
- Conditions
- Myopia
- Being tested
- Atropine sulfate 0.01%, Placebo
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine sulfate 0.01%Drug
Atropine 0.01%
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Premyopia atropine | Active comparator | On Atropine 0.01% Receives: Drug: Atropine sulfate 0.01% |
| Premyopia placebo | Placebo comparator | On placebo Receives: Drug: Placebo |
| Low myopia atropine | Active comparator | On Atropine 0.01% daily or every other day Receives: Drug: Atropine sulfate 0.01% |
| Low myopia placebo | Placebo comparator | On placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical Equivalent
SE
Measured: 3.5 years
Secondary outcomes (1)
Axial Length
AL
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start21 Apr 2017
- Primary completion31 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Model description
- Randomized control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Principal investigator, Audrey Chia Wei-Lin, Singapore National Eye Centre
- Investigators
- Audrey Chia, Principal investigator, Singapore National Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140358
- Sponsor's protocol ID
- R1359/45/2016
- Status last verified
- May 2025
- First submitted
- 2 May 2017
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
- ClinicalTrials.gov ID
- NCT03140358
- Acronym / sponsor ID
- R1359/45/2016
- Conditions
- Myopia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 May 2017 (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.
Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.
Detailed description
High risk children (with family history of myopia) with low hyperopia or low myopia will be randomized to atropine or placebo, with 2 -2.5 year treatment and 1 year washout.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Premyopia atropine | Active comparator | Drug: Atropine sulfate 0.01%On Atropine 0.01% |
| Premyopia placebo | Placebo comparator | Drug: PlaceboOn placebo |
| Low myopia atropine | Active comparator | Drug: Atropine sulfate 0.01%On Atropine 0.01% daily or every other day |
| Low myopia placebo | Placebo comparator | Drug: PlaceboOn placebo |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- One parent with myopia (<-3D in at least one eye)
- SE +1.00D to -1.50D
- Astigmatism < = 1.50D
- Distance vision logMAR 0.2 or better in both eyes
- Intraocular pressure of not greater than 21 mmHg
Key exclusion criteria (4 listed)
- Any eye or systemic disease that affect vision or refractive error
- Conditions where topical atropine contraindicated
- Previous use of atropine or pirenzepine
- Known past/current amblyopia or strabismus
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 |
|---|---|---|
| Atropine sulfate 0.01%Atropine 0.01% | Drug | Low myopia atropine, Premyopia atropine |
| Placeboplacebo | Drug | Low myopia placebo, Premyopia placebo |
Primary outcome
Spherical Equivalent
Time frame: 3.5 years
SE
1 secondary outcome
Axial Length
Time frame: 3.5 years
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 18 May 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Audrey Chia principal investigator
Singapore National Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atropine sulfate 0.01% in people with Myopia, run by Singapore National Eye Centre at 1 site in Singapore.
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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical Equivalent (time frame: 3.5 years). 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 18 May 2025.