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Active, not recruitingNCT03140358Updated May 18, 2025

The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)

A Phase 3 interventional study of Atropine sulfate 0.01% and Placebo in Myopia, sponsored by Singapore National Eye Centre. Active, not recruiting at 1 site in Singapore. Open to participants aged 5 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-18.

Sponsored by Singapore National Eye Centre · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
5 Years to 9 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Myopia

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 300 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Singapore National Eye Centre is the lead sponsor of 84 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. One parent with myopia (\<-3D in at least one eye)
  2. SE +1.00D to -1.50D
  3. Astigmatism \< = 1.50D
  4. Distance vision logMAR 0.2 or better in both eyes
  5. Intraocular pressure of not greater than 21 mmHg
  6. No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride

Exclusion criteria

Exclusion Criteria:

  1. Any eye or systemic disease that affect vision or refractive error
  2. Conditions where topical atropine contraindicated
  3. Previous use of atropine or pirenzepine
  4. Known past/current amblyopia or strabismus
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • Active comparator
    Premyopia atropine

    On Atropine 0.01%

    Drug: Atropine sulfate 0.01%

  • Placebo comparator
    Premyopia placebo

    On placebo

    Drug: Placebo

  • Active comparator
    Low myopia atropine

    On Atropine 0.01% daily or every other day

    Drug: Atropine sulfate 0.01%

  • Placebo comparator
    Low myopia placebo

    On placebo

    Drug: Placebo

Interventions

  • DrugAtropine sulfate 0.01%

    Atropine 0.01%

  • DrugPlacebo

    placebo

06

What researchers measure

Primary outcomes

  1. Spherical Equivalent

    SE

    Time frame: 3.5 years

Secondary outcomes

  1. Axial Length

    AL

    Time frame: 3.5 years

07

Study locations

1 site
  • Singapore eye research institute
    Singapore, 423699, Singapore
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03140358
Lead sponsor
Singapore National Eye Centre
Collaborators
National Medical Research Council (NMRC), Singapore
Responsible party
Audrey Chia Wei-Lin (Adjuct Associate Professor, Singapore National Eye Centre) — Principal investigator
First posted
May 4, 2017
Start date
Apr 21, 2017
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025 (estimated)
Last update
May 18, 2025

Study contacts

Audrey Chia
principal investigator · Singapore National Eye Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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