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 ≥ -0.5D/yr.
- SER of at least -1.50D 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 angle ofresolution) 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 the durationof the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30days 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 ofartificial tears is allowed but not in the 1 hour before or after the administrationof the study medication.
- The anticipated need to use chronic ophthalmic or systemic oral corticosteroids duringthe 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,
NetherlandsSite Not Available
Bergman Clinics - Ede
Ede,
NetherlandsSite Not Available
Medisch Spectrum Twente
Enschede,
NetherlandsSite Not Available
Admiraal de Ruyter Ziekenhuis
Goes,
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
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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