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

• Status: Recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and Safety Study of QLM3004 in Myopic Children

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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