Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferior, Phase Ⅱb/Ⅲ Study to Evaluate the Safety and Efficacy of CTO0303
1 other identifier
interventional
156
1 country
1
Brief Summary
This is a prospective randomized study compared with active control arm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2024
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 9, 2024
CompletedFirst Submitted
Initial submission to the registry
September 20, 2024
CompletedFirst Posted
Study publicly available on registry
September 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedSeptember 24, 2024
January 1, 2024
8 months
September 20, 2024
September 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pupillary dilation effect at 30 minutes after administration
The pupil size is measured using a pupillometer 30 minutes after IP administration
From enrollment to the end of treatment at 1 day.
Study Arms (3)
CTO0303-A
EXPERIMENTALCTO0303-B
EXPERIMENTALCTO0303-C
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gachon University Gil Medical Center
Incheon, 21565, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2024
First Posted
September 24, 2024
Study Start
May 9, 2024
Primary Completion
December 31, 2024
Study Completion
March 1, 2025
Last Updated
September 24, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share