Using QLM3004 to slow down 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

This study is testing if a new eye drop called QLM3004 can help slow down worsening eyesight in children aged 6 to 12 who have myopia.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 735 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Wenzhou, Zhejiang)
• Trial ID: NCT06151587 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of QLM3004 in children aged 6 to 12 years with myopia ranging from -1.00D to -4.00D. The study consists of two phases: the first phase assesses the effectiveness of three different concentrations of QLM3004 compared to a placebo over a 96-week treatment period. The second phase involves a post-withdrawal observation period to gather additional data on the treatment's effects after stopping the medication.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 to 12 years with myopia between -1.00D and -4.00D.

Not a fit: Patients with serious systemic diseases, significant eye diseases, or those currently using other myopia control methods may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly slow the progression of myopia in children, potentially reducing the risk of severe vision problems later in life.

How similar studies have performed: Other studies have explored myopia control methods, but the specific approach using QLM3004 is novel and has not been widely tested.

Eligibility criteria

Inclusion Criteria:

* Age 6 to 12 years
* Myopia -1.00D to -4.00D spherical equivalent (SE) in both eyes as measured by cycloplegic autorefraction.
* Astigmatism ≤1.50 D in both eyes.
* Anisometropia ≤1.50 D SE.
* Informed consent signed by the subjects and/or their legal representatives

Exclusion Criteria:

* Suffering from serious systemic diseases
* Any eye disease that affect vision or refractive error
* Current or prior history of manifest strabismus, amblyopia, or other ocular pathologic changes
* Acute inflammatory disease or active infection of the eye in either eye, or a history of chronic ocular inflammation or recurrent episodes of ocular inflammation
* Best corrected distance visual acuity in both eyes\<4.9
* Abnormal intra-ocular pressure (\>21 mmHg or difference between two eyes \>5mmHg)
* Current or previous form of myopia control, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc.
* Systemic or topical use of medications within 3 months that interfere with efficacy evaluation (excluding optometry)
* Allergy or hypersensitivity to atropine, excipients, cyclopentolate or fluorescein sodium
* Participants for whom the clinical significance of ophthalmologic examination abnormalities indicate that one or both eyes are not suitable candidates for treatment based upon the Investigator's medical judgment
* Participation of the drug clinical trial within three month and the device clinical trial within one month
* Anticipated long-term use of ocular or systemic oral corticosteroids during the study period
* Any other condition not suitable for the study per investigator's judgement

Where this trial is running

Wenzhou, Zhejiang

• The Affiliated Eye Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Zhenjiang Wang

Conditions Myopia