UnknownPhase 2/3

Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects

South Korea156 participantsStarted 2024-05-09

Plain-language summary

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

Who can participate

Age range

4 Years – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

pupillary dilation effect at 30 minutes after administration

Timeframe: From enrollment to the end of treatment at 1 day.

Trial details

NCT IDNCT06609525

SponsorTaejoon Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Sukyoung Kwon, MPH., PhD

+82-799-0175 skkwon@taejoon.co.kr

View on ClinicalTrials.gov More Pupillary Dilation Effect During Cycloplegic Refraction trials

Who can participate

Age range

4 Years – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.