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RECRUITING
NCT06151587
PHASE3

A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

Efficacy and Safety Study of QLM3004 in Myopic Children

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Different Concentrations of QLM3004 in Delaying the Progression of Myopia in Children

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

735

Start Date

2023-08-20

Completion Date

2027-06

Last Updated

2023-11-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

QLM3004 Concentration 1

Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime

DRUG

QLM3004 Concentration 2

Medium dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime

DRUG

QLM3004 Concentration 3

High dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime

OTHER

Placebo

Vehicle

Locations (1)

The Affiliated Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China