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

Myopia Clinical Trial

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

Clinical Trial Summary

Efficacy and Safety Study of QLM3004 in Myopic Children

Clinical Trial Description

The study was divided into 2 phases, with Stage 1 being the primary efficacy and safety confirmation phase and Stage 2 a post-withdrawal observation period. Stage 1:To evaluate the safety and efficacy of 3 concentrations of QLM3004 compared to Vehicle (placebo)for slowing the progression of myopia in children over a 96-week treatment period. Stage 2:subjects will enter Period 2 of the study, and Period 2 will be a post-withdrawal observation period, which will not serve as a validation basis for the efficacy and safety of QLM3004. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06151587
Study type Interventional
Source Qilu Pharmaceutical Co., Ltd.
Contact Zhenjiang Wang
Phone 0531-55821369
Email zhenjiang.wang@qilu-pharma.com
Status Recruiting
Phase Phase 3
Start date August 20, 2023
Completion date June 2027
View Details
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