No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 – 11
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
550 (estimated)
Sponsor
Erasmus Medical Center · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Children aged 6 to ≤ 11 years with bilateral myopia
* Onset of myopia ≥ 4 years of age
* History of progression
* SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction
* Intraocular pressure \< 21 mm Hg in each eye
* Distance …
Inclusion Criteria:
* Children aged 6 to ≤ 11 years with bilateral myopia
* Onset of myopia ≥ 4 years of age
* History of progression
* SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction
* Intraocular pressure \< 21 mm Hg in each eye
* Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eye
Exclusion Criteria:
* Allergy to atropine or other excipients of the eye drops
* History of amblyopia or strabismus
* History of retinal dystrophy or systemic disorder
* Abnormal ocular biometry aside from axial length
* History of glaucoma
* Chronic 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.
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