Status:
RECRUITING
A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Myopia
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
Efficacy and Safety Study of QLM3004 in Myopic Children
Detailed Description
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 efficac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
735 Patients enrolled
Trial Details
Trial ID
NCT06151587
Start Date
August 20 2023
End Date
June 1 2027
Last Update
November 30 2023
Active Locations (1)
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1
The Affiliated Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China