Status:
RECRUITING
Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects
Lead Sponsor:
Taejoon Pharmaceutical Co., Ltd.
Conditions:
Pupillary Dilation Effect During Cycloplegic Refraction
Eligibility:
All Genders
4-15 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a prospective randomized study compared with active control arm.
Detailed Description
This is a prospective randomized study compared with active control arm. The investigators compare the pupil size in subject when 30 minutes after administering IP (CTO0303 or active control).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT06609525
Start Date
May 9 2024
End Date
March 1 2025
Last Update
September 24 2024
Active Locations (1)
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1
Gachon University Gil Medical Center
Incheon, South Korea, 21565