Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects

Phase 2

Recruiting

• Conditions: Pupillary Dilation Effect During Cycloplegic Refraction
• Interventions: Drug: CTO0303-B; Drug: CTO0303-C; Drug: 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).

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-05-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-01

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

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of