A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferior, Phase Ⅱb/Ⅲ Study to Evaluate the Safety and Efficacy of CTO0303

Taejoon Pharmaceutical Co., Ltd.1 site in 1 country156 target enrollmentMay 9, 2024

ConditionsPupillary Dilation Effect During Cycloplegic Refraction

InterventionsCTO0303-A CTO0303-B CTO0303-C

DrugsCTO0303-A CTO0303-B CTO0303-C

Overview

Phase: Phase 2
Intervention: CTO0303-A
Conditions: Pupillary Dilation Effect During Cycloplegic Refraction
Sponsor: Taejoon Pharmaceutical Co., Ltd.
Enrollment: 156
Locations: 1
Primary Endpoint: pupillary dilation effect at 30 minutes after administration
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 9, 2024

End Date

March 1, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Taejoon Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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