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

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ClinicalTrials.gov Identifier: NCT03140358
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
Audrey Chia Wei-Lin, Singapore National Eye Centre

Tracking Information
First Submitted Date  ICMJE May 2, 2017
First Posted Date  ICMJE May 4, 2017
Last Update Posted Date October 26, 2017
Actual Study Start Date  ICMJE April 21, 2017
Estimated Primary Completion Date May 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
Spherical Equivalent [ Time Frame: 3.5 years ]
SE
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
Axial Length [ Time Frame: 3.5 years ]
AL
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
Official Title  ICMJE The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE
  • Drug: Atropine sulfate 0.01%
    Atropine 0.01%
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • Active Comparator: Premyopia atropine
    On Atropine 0.01%
    Intervention: Drug: Atropine sulfate 0.01%
  • Placebo Comparator: Premyopia placebo
    On placebo
    Intervention: Drug: Placebo
  • Active Comparator: Low myopia atropine
    On Atropine 0.01% daily or every other day
    Intervention: Drug: Atropine sulfate 0.01%
  • Placebo Comparator: Low myopia placebo
    On placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2017)
570
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2, 2023
Estimated Primary Completion Date May 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Su Ann Tay +6593395137 tay.su.ann@singhealth.com.sg
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03140358
Other Study ID Numbers  ICMJE R1359/45/2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Audrey Chia Wei-Lin, Singapore National Eye Centre
Study Sponsor  ICMJE Singapore National Eye Centre
Collaborators  ICMJE National Medical Research Council (NMRC), Singapore
Investigators  ICMJE
Principal Investigator: Audrey Chia Singapore National Eye Center
PRS Account Singapore National Eye Centre
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP