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Completed
NCT03334253
Low-Dose Atropine for Treatment of Myopia
Conditions: Myopia
Sex: All
Ages: 5 Years – 12 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 200
Sponsor: Jaeb Center for Health Research
Location: University of Alabama at Birmingham Birmingham Alabama
Summary
Study Objectives
The objectives for this randomized trial are:
1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment).
2. To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).
Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
Eligibility Criteria
Inclusion Criteria:
* Age 5 years to \
Source: ClinicalTrials.gov (NCT03334253). StuddyBuddy aggregates publicly available trial information.