Comparing Efficacy and Safety of CTO0303 in Pediatric Sub... | NCT06609525

Studies
Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects

NCT06609525

Sponsor

Taejoon Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Sep 24, 2024Actual

Enrollment

156Estimated

Phase

Phase 2Phase 3

Conditions

Pupillary Dilation Effect During Cycloplegic Refraction

Interventions

CTO0303-A
CTO0303-B
CTO0303-C

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 9, 2024Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Mar 1, 2025Estimated

First Submitted Date

Sep 20, 2024

First Submission Date that Met QC Criteria

Sep 20, 2024

First Posted Date

Sep 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2024

Last Update Posted Date

Sep 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

156Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
CTO0303-A	Experimental	Drug: CTO0303-A
CTO0303-B	Experimental	Drug: CTO0303-B
CTO0303-C	Active Comparator	Drug: CTO0303-C

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CTO0303-A	Drug	eye drop, 1 drop 3 times (every 5 minutes) a day	CTO0303-A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gachon University Gil Medical Center	Recruiting	Incheon		21565	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015878	Mydriasis

Ancestor Terms

ID	Term
D011681	Pupil Disorders
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided