Using QLM3004 to slow down myopia in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Zhenjiang Wang
• Email: zhenjiang.wang@qilu-pharma.com
• Phone: 0531-55821369

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.