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

Inclusion Criteria:

• Age 6 to 12 years
• Myopia -1.00D to -4.00D spherical equivalent (SE) in both eyes as measured bycycloplegic 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 pathologicchanges
• Acute inflammatory disease or active infection of the eye in either eye, or a historyof 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 efficacyevaluation (excluding optometry)
• Allergy or hypersensitivity to atropine, excipients, cyclopentolate or fluoresceinsodium
• Participants for whom the clinical significance of ophthalmologic examinationabnormalities indicate that one or both eyes are not suitable candidates for treatmentbased upon the Investigator's medical judgment
• Participation of the drug clinical trial within three month and the device clinicaltrial within one month
• Anticipated long-term use of ocular or systemic oral corticosteroids during the studyperiod
• Any other condition not suitable for the study per investigator's judgement