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.
Phase:
Phase 3
Details
Lead Sponsor:
Jaeb Center for Health Research
Collaborators:
National Eye Institute (NEI) Pediatric Eye Disease Investigator Group