Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects (NCT06609525) | Clinical Trial Compass
UnknownPhase 2/3
Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects
South Korea156 participantsStarted 2024-05-09
Plain-language summary
This is a prospective randomized study compared with active control arm.
Who can participate
Age range4 Years – 15 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pediatric or adolescent subjects those who get a written consent both whom and their parents (or legally acceptable representative)
* Pediatric or adolescent subjects aged 4 to 15 years old based on date of written consent
Exclusion Criteria:
* Subjects with a history of severe systemic reaction or increased sensitivity to atropine
* Subjects with anterior segment disease that interferes with ophthalmological examination (ex. corneal scar, corneal opacity and others)
* Subjects administered mydriatic medication within 14 days prior to administration of Investigational Product
* Subjects with contact lens
What they're measuring
1
pupillary dilation effect at 30 minutes after administration
Timeframe: From enrollment to the end of treatment at 1 day.