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

Primary Purpose

Myopia

Status
Active
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Atropine sulfate 0.01%
Placebo
Sponsored by
Singapore National Eye Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

5 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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:

  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

Sites / Locations

  • Singapore eye research institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Premyopia atropine

Premyopia placebo

Low myopia atropine

Low myopia placebo

Arm Description

On Atropine 0.01%

On placebo

On Atropine 0.01% daily or every other day

On placebo

Outcomes

Primary Outcome Measures

Spherical Equivalent
SE

Secondary Outcome Measures

Axial Length
AL

Full Information

First Posted
May 2, 2017
Last Updated
March 15, 2023
Sponsor
Singapore National Eye Centre
Collaborators
National Medical Research Council (NMRC), Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT03140358
Brief Title
The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
Official Title
The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 21, 2017 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore National Eye Centre
Collaborators
National Medical Research Council (NMRC), Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Premyopia atropine
Arm Type
Active Comparator
Arm Description
On Atropine 0.01%
Arm Title
Premyopia placebo
Arm Type
Placebo Comparator
Arm Description
On placebo
Arm Title
Low myopia atropine
Arm Type
Active Comparator
Arm Description
On Atropine 0.01% daily or every other day
Arm Title
Low myopia placebo
Arm Type
Placebo Comparator
Arm Description
On placebo
Intervention Type
Drug
Intervention Name(s)
Atropine sulfate 0.01%
Intervention Description
Atropine 0.01%
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Spherical Equivalent
Description
SE
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
Axial Length
Description
AL
Time Frame
3.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey Chia
Organizational Affiliation
Singapore National Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore eye research institute
City
Singapore
ZIP/Postal Code
423699
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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