MAD Trial: Myopia Atropine Dose

The goal of this interventional study is to compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment against progression of axial length in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. Subjects will use Atropine eye drops for a period of 3 years, followed by a 2 year observational period.

Inclusion Criteria:Children aged 6 to ≤ 11 years with bilateral myopiaOnset of myopia ≥ 4 years of ageHistory of progression ≥ -0.5D/yr.SER of at least -1.50D and no greater than -6.00D in each eye measured using cycloplegic auto refractionIntraocular pressure < 21 mm Hg in each eyeDistance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eyeExclusion Criteria:Allergy to atropine or other excipients of the eye dropsHistory of amblyopia or strabismusHistory of retinal dystrophy or systemic disorderAbnormal ocular biometry aside from axial lengthHistory of glaucomaChronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic use over the duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days in 1 year).Chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. The use of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication.The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., < 2 weeks)Prior myopia treatments.Employees of the study center and their family members.