MAD Trial: Myopia Atropine Dose

Recruiting Phase 3 Interventional Study
Progressive Myopia
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
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About This Trial

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 …
Contacts

Jan Roelof Polling, Dr.

+31628449254

j.polling@erasmusmc.nl

CONTACT

Trialbureau Oogheelkunde

+31107039740

research.oogheelkunde@erasmusmc.nl

CONTACT