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

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.

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