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RecruitingNCT06609525Updated Sep 24, 2024

Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects

A Phase 2/3 interventional study of CTO0303-A and CTO0303-B in Pupillary Dilation Effect During Cycloplegic Refraction, sponsored by Taejoon Pharmaceutical Co., Ltd.. Recruiting at 1 site in Korea, Republic of. Open to participants aged 4 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-24.

Sponsored by Taejoon Pharmaceutical Co., Ltd. · Phase 2/3, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled May 2024, registered Sep 2024).
  • Started May 2024; still recruiting 2 years 6 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
156
Allocation
Randomized
Ages
4 Years to 15 Years
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Pupillary Dilation Effect During Cycloplegic Refraction

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Keywords

  • pupillary dilation
03

In context

Mydriasis

37 studies on the registry are indexed under Mydriasis; 4 are open to participants now.

This study's planned enrollment of 156 is above the median of 61 across 35 interventional studies indexed under Mydriasis.

Browse Mydriasis studies →

Lead sponsor

Taejoon Pharmaceutical Co., Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 Product
  • Subjects with contact lens
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
156 participants (estimated)

Study arms

  • Experimental
    CTO0303-A

    Drug: CTO0303-A

  • Experimental
    CTO0303-B

    Drug: CTO0303-B

  • Active comparator
    CTO0303-C

    Drug: CTO0303-C

Interventions

  • DrugCTO0303-A

    eye drop, 1 drop 3 times (every 5 minutes) a day

  • DrugCTO0303-B

    eye drop, 1 drop 3 times (every 5 minutes) a day

  • DrugCTO0303-C

    eye drop, 1 drop 3 times (every 5 minutes) a day

06

What researchers measure

Primary outcomes

  1. pupillary dilation effect at 30 minutes after administration

    The pupil size is measured using a pupillometer 30 minutes after IP administration

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06609525
Responsible party
Sponsor
First posted
Sep 24, 2024
Start date
May 9, 2024
Primary completion
Dec 31, 2024 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Sep 24, 2024

Study contacts

Sukyoung Kwon, MPH., PhD
Contact
skkwon@taejoon.co.kr
+82-799-0175
hyejeong Paik, MD
Contact
hjpaik@gilhospital.com
+82-032-460-2751

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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