The Use of Atropine 0.01% in the Prevention and Control o... | NCT03140358

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

NCT03140358

Sponsor

Singapore National Eye Centre

Status

Active, not recruiting

Last Update Posted

May 18, 2025Actual

Enrollment

300Actual

Phase

Phase 3

Conditions

Myopia

Interventions

Atropine sulfate 0.01%
Placebo

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 21, 2017Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 31, 2025Estimated

First Submitted Date

May 2, 2017

First Submission Date that Met QC Criteria

May 2, 2017

First Posted Date

May 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2025

Last Update Posted Date

May 18, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Audrey Chia Wei-Lin, Adjuct Associate Professor, Singapore National Eye CentrePrincipal Investigator

Lead Sponsor

Singapore National Eye CentreOTHER_GOV

Collaborators

Name	Class
National Medical Research Council (NMRC), Singapore	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Atropine sulfate 0.01%	Drug	Atropine 0.01%	Low myopia atropine Premyopia atropine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spherical Equivalent	SE	3.5 years

Secondary Outcomes

Measure	Description	Time Frame
Axial Length	AL	3.5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Audrey Chia	Singapore National Eye Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Singapore eye research institute		Singapore		423699	Singapore

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases