Phase
Condition
Myopia
Treatment
Atropine Ophthalmic 0.5%
Atropine Ophthalmic 0.05%
Clinical Study ID
Ages 6-11 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 usingcycloplegic auto refraction
Intraocular pressure < 21 mm Hg in each eye
Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angleof resolution) in each eye
Exclusion
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 theduration of the study (i.e., more than 7 consecutive days in 1 month or more than atotal 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 useof artificial tears is allowed but not in the 1 hour before or after theadministration of the study medication.
The anticipated need to use chronic ophthalmic or systemic oral corticosteroidsduring the study. (i.e., < 2 weeks)
Prior myopia treatments.
Employees of the study center and their family members.
Study Design
Study Description
Connect with a study center
Noordwest Ziekenhuisgroep
Alkmaar,
NetherlandsSite Not Available
Flevoziekenhuis
Almere,
NetherlandsActive - Recruiting
OLVG, locatie Oost
Amsterdam,
NetherlandsActive - Recruiting
Ophthalmologistenpraktijk Delfland
Delft,
NetherlandsActive - Recruiting
Reinier de Graaf Gasthuis
Delft,
NetherlandsActive - Recruiting
Bergman Clinics - Den Bosch
Den Bosch,
NetherlandsSite Not Available
Haaglanden Medisch Centrum
Den Haag,
NetherlandsSite Not Available
Haga Ziekenhuis
Den Haag,
NetherlandsActive - Recruiting
Oogkliniek Den Haag
Den Haag,
NetherlandsActive - Recruiting
Deventer Ziekenhuis
Deventer,
NetherlandsActive - Recruiting
Albert Schweitzer ziekenhuis
Dordrecht,
NetherlandsActive - Recruiting
Bergman Clinics - Ede
Ede,
NetherlandsActive - Recruiting
Medisch Spectrum Twente
Enschede,
NetherlandsSite Not Available
Admiraal de Ruyter Ziekenhuis
Goes,
NetherlandsActive - Recruiting
Frisius MC
Heerenveen,
NetherlandsActive - Recruiting
Tjongerschans Heerenveen
Heerenveen,
NetherlandsActive - Recruiting
Oogcentrum Noordholland
Heerhugowaard,
NetherlandsActive - Recruiting
Isala - Kampen
Kampen,
NetherlandsSite Not Available
Leiden University Medical Center
Leiden,
NetherlandsActive - Recruiting
Bergman Clinics - Lelystad
Lelystad,
NetherlandsActive - Recruiting
Maastricht UMC+
Maastricht,
NetherlandsActive - Recruiting
Isala - Meppel
Meppel,
NetherlandsSite Not Available
St. Antonius
Nieuwegein,
NetherlandsActive - Recruiting
Radboudumc
Nijmegen,
NetherlandsActive - Recruiting
Erasmus Medical Center
Rotterdam,
NetherlandsActive - Recruiting
Ziekenhuis Rivierenland Tiel
Tiel,
NetherlandsActive - Recruiting
Elisabeth-TweeSteden Ziekenhuis
Tilburg,
NetherlandsActive - Recruiting
Isala - Zwolle
Zwolle,
NetherlandsSite Not Available
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