Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects

Taejoon Pharmaceutical

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Pupillary Dilation Effect During Cycloplegic Refraction

Treatments: Drug: CTO0303-B; Drug: CTO0303-C; Drug: CTO0303-A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06609525

CTO0303

Details and patient eligibility

About

This is a prospective randomized study compared with active control arm.

Full 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).

Enrollment: 156 estimated patients

Sex: All

Ages: 4 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 3 patient groups

CTO0303-A

Experimental group

Treatment:

Drug: CTO0303-A

CTO0303-B

Experimental group

Treatment:

Drug: CTO0303-B

CTO0303-C

Active Comparator group

Treatment:

Drug: CTO0303-C