Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects
Phase 2
Recruiting
- Conditions
- Pupillary Dilation Effect During Cycloplegic Refraction
- Interventions
- Drug: CTO0303-BDrug: CTO0303-CDrug: CTO0303-A
- Registration Number
- NCT06609525
- Lead Sponsor
- Taejoon Pharmaceutical Co., Ltd.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 156
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CTO0303-B CTO0303-B - CTO0303-C CTO0303-C - CTO0303-A CTO0303-A -
- Primary Outcome Measures
Name Time Method pupillary dilation effect at 30 minutes after administration From enrollment to the end of treatment at 1 day. The pupil size is measured using a pupillometer 30 minutes after IP administration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of