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

• Sponsor: Singapore National Eye Centre (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03140358
• Collaborator: National Medical Research Council (NMRC), Singapore (Other)
• Enrollment: 570
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 72.3
• Patients Per Site Per Month: 7.9

Study Details

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.

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

• Study Type: Interventional
• Anticipated Enrollment: 570 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized control trialRandomized 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: Apr 21, 2017
• Anticipated Primary Completion Date: May 2, 2021
• Anticipated Study Completion Date: May 2, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Spherical Equivalent [3.5 years]

   SE

Secondary Outcome Measures

1. Axial Length [3.5 years]

   AL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Singapore eye research institute	Singapore		Singapore	423699

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Audrey Chia, Singapore National Eye Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Last Update Posted: Oct 26, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia; Atropine

Study Results

No Results Posted as of Oct 26, 2017