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Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects

Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects

Recruiting
4-15 years
All
Phase 2/3

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Overview

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

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

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 details
    Pupillary Dilation Effect During Cycloplegic Refraction

NCT06609525

Taejoon Pharmaceutical Co., Ltd.

14 October 2025

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