Comparing the effects of CTO0303 on pupil size in children
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferior, Phase Ⅱb/Ⅲ Study to Evaluate the Safety and Efficacy of CTO0303
This study is testing if a new treatment called CTO0303 can make children's pupils dilate more than a standard treatment.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 4 Years to 15 Years |
| Sex | All |
| Sponsor | Taejoon Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Incheon) |
| Trial ID | NCT06609525 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective randomized study that evaluates the efficacy and safety of CTO0303 in pediatric subjects aged 4 to 15 years. Participants will receive either the investigational product CTO0303 or an active control, and their pupil size will be measured 30 minutes post-administration. The study aims to determine how well CTO0303 induces pupillary dilation compared to the control. The trial is designed to provide insights into the effectiveness of this treatment in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric or adolescent subjects aged 4 to 15 years who can provide written consent along with their parents or legal representatives.
Not a fit: Patients with a history of severe reactions to atropine or those with anterior segment diseases that affect eye examinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for inducing pupillary dilation in children, enhancing the accuracy of ophthalmological examinations.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating pupillary dilation effects in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Incheon
- Gachon University Gil Medical Center — Incheon, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Sukyoung Kwon, MPH., PhD
- Email: skkwon@taejoon.co.kr
- Phone: +82-799-0175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.