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Clinical trial

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

ID
Name
R1359/45/2016
Description
Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.
Trial arms
Trial start
2017-04-21
Estimated PCD
2025-12-31
Trial end
2025-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Atropine sulfate 0.01%
Atropine 0.01%
Arms:
Low myopia atropine, Premyopia atropine
Placebo
placebo
Arms:
Low myopia placebo, Premyopia placebo
Size
300
Primary endpoint
Spherical Equivalent
3.5 years
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 300, 'type': 'ACTUAL'}}
Updated at
2023-03-16

1 organization

1 product

1 drug

1 indication

Organization
Singapore National Eye Centre
Product
Atropine sulfate
Indication
Myopia
Drug
Varlilumab