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

QLM3004-301

Efficacy and Safety Study of QLM3004 in Myopic Children

2023-08-20

2026-06-01

2027-06-01

Recruiting

Early phase I

735

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 735, 'type': 'ESTIMATED'}}

2023-11-30