MedPath

MAD

Phase 1
Conditions
Myopia
Therapeutic area: Diseases [C] - Eye Diseases [C11]
Registration Number
CTIS2024-516379-34-00
Lead Sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
550
Inclusion Criteria

Children aged 6 to = 11 years with bilateral myopia, Onset of myopia = 4 years of age, History of myopia 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

Exclusion Criteria

Allergy to atropine, History of amblyopia or strabismus, glaucoma or retinal dystrophy or systemic disorder that predisposes to severe myopia (e.g., Marfan syndrome, retinitis pigmentosa, Stickler syndrome, retinopathy of prematurity)., Prior myopia control treatment (Atropine, ortho-keratology, multifocal contact lenses, Glaucoma

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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