Investigator Led, Double-masked, Multicenter, Randomized Clinical Trial for the Comparison of Atropine 0.5% Versus Atropine 0.05% Eye Drops for the Prevention of Myopia Progression in Dutch Children

NL78526.078.21

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.

2022-12-19

2028-12-01

2028-12-01

Recruiting

Early phase I

550

Inclusion Criteria: * Children aged 6 to ≤ 11 years with bilateral myopia * Onset of myopia ≥ 4 years of age * History of progression ≥ -0.5D/yr. * SER of at least -1.50D 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 550, 'type': 'ESTIMATED'}}

2024-02-20