NCT06151587

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 735 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Efficacy and Safety Study of QLM3004 in Myopic Children

Detailed 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.

Conditions

• Myopia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-20
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2023-11-30
• Last updated: 2023-11-30

Locations

1 site across 1 country: China