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

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

Study Overview

• Status: Recruiting
• Conditions: Pupillary Dilation Effect During Cycloplegic Refraction
• Intervention / Treatment: Drug: CTO0303-A; Drug: CTO0303-B; Drug: CTO0303-C

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).

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Sukyoung Kwon, MPH., PhD; Phone Number: +82-799-0175; Email: skkwon@taejoon.co.kr
• Study Contact Backup: Name: hyejeong Paik, MD; Phone Number: +82-032-460-2751; Email: hjpaik@gilhospital.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 21565
    • Recruiting
    • Gachon University Gil Medical Center
    • Contact: Hyejeong Paik, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTO0303-A	Drug: CTO0303-A; eye drop, 1 drop 3 times (every 5 minutes) a day
Experimental: CTO0303-B	Drug: CTO0303-B; eye drop, 1 drop 3 times (every 5 minutes) a day
Active Comparator: CTO0303-C	Drug: CTO0303-C; eye drop, 1 drop 3 times (every 5 minutes) a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Taejoon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 20, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: pupillary dilation
• Additional Relevant MeSH Terms: Eye Diseases; Pathological Conditions, Anatomical; Pupil Disorders; Dilatation, Pathologic; Mydriasis
• Other Study ID Numbers: CTO0303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No