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

NCT03140358 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: R1359/45/2016
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Spherical Equivalent

  SE

  3.5 years

Secondary Outcomes (1)

• Axial Length

  3.5 years

Study Arms (4)

Premyopia atropine

ACTIVE COMPARATOR

On Atropine 0.01%

Drug: Atropine sulfate 0.01%

Premyopia placebo

PLACEBO COMPARATOR

On placebo

Drug: Placebo

Low myopia atropine

ACTIVE COMPARATOR

On Atropine 0.01% daily or every other day

Drug: Atropine sulfate 0.01%

Low myopia placebo

PLACEBO COMPARATOR

On placebo

Drug: Placebo

Interventions

Atropine sulfate 0.01% DRUG

Atropine 0.01%

Low myopia atropine; Premyopia atropine

Placebo DRUG

placebo

Low myopia placebo; Premyopia placebo

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore National Eye Centre: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

Singapore eye research institute

Singapore, 423699, Singapore

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Audrey Chia

  Singapore National Eye Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjuct Associate Professor

Model Details: Randomized control trial

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: April 21, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)