A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children - Trial NCT06151587

Name: Clinical Trial NCT06151587
Creator: Qilu Pharmaceutical Co., Ltd.
Keywords: Myopia, QLM3004 Concentration 1, Phase 3, drug, clinical trial, China

Access comprehensive clinical trial information for NCT06151587 through Pure Global AI's free database. This Phase 3 trial is sponsored by Qilu Pharmaceutical Co., Ltd. and is currently Recruiting. The study focuses on Myopia. Target enrollment is 735 participants.

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NCT06151587

Phase 3

Recruiting

drug

Trial Details

ClinicalTrials.gov • NCT06151587

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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

Study Focus

Disease/Condition

Myopia

Drug/Device/Intervention

QLM3004 Concentration 1

Study Type

Interventional

Intervention Type

drug

Sponsor & Location

Primary Sponsor

Qilu Pharmaceutical Co., Ltd.

Location

Wenzhou, China

Timeline & Enrollment

Phase

Phase 3

Start Date

Aug 20, 2023

End Date

Jun 01, 2027

Enrollment

735 participants

Primary Outcome

Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96.

Summary

Efficacy and Safety Study of QLM3004 in Myopic Children

ICD-10 Classifications

Myopia

Degenerative myopia

Amblyopia ex anopsia

Ocular myiasis

Myiasis

Data Source

Registry

ClinicalTrials.gov

Trial ID

NCT06151587

Type

Non-Device Trial