The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03140358
Recruitment Status : Active, not recruiting
First Posted : May 4, 2017
Last Update Posted : March 16, 2023
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Audrey Chia Wei-Lin, Singapore National Eye Centre

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Myopia Drug: Atropine sulfate 0.01% Drug: Placebo Phase 3

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
Actual Study Start Date : April 21, 2017
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Premyopia atropine
On Atropine 0.01%
 Drug: Atropine sulfate 0.01%
Atropine 0.01%
Placebo Comparator: Premyopia placebo
On placebo
 Drug: Placebo
placebo
Active Comparator: Low myopia atropine
On Atropine 0.01% daily or every other day
 Drug: Atropine sulfate 0.01%
Atropine 0.01%
Placebo Comparator: Low myopia placebo
On placebo
 Drug: Placebo
placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Spherical Equivalent [ Time Frame: 3.5 years ]
    SE


Secondary Outcome Measures :
  1. Axial Length [ Time Frame: 3.5 years ]
    AL


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140358


Locations
Layout table for location information
Singapore
Singapore eye research institute
Singapore, Singapore, 423699
Sponsors and Collaborators
Singapore National Eye Centre
National Medical Research Council (NMRC), Singapore
Investigators
Layout table for investigator information
Principal Investigator: Audrey Chia Singapore National Eye Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Audrey Chia Wei-Lin, Adjuct Associate Professor, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT03140358    
Other Study ID Numbers: R1359/45/2016
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Myopia
Refractive Errors
Eye Diseases
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action