Actively Recruiting
A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2023-11-30
735
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Efficacy and Safety Study of QLM3004 in Myopic Children
CONDITIONS
Official Title
A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 to 12 years
- Myopia between -1.00D and -4.00D spherical equivalent in both eyes measured by cycloplegic autorefraction
- Astigmatism 1.50D or less in both eyes
- Anisometropia 1.50D spherical equivalent or less
- Signed informed consent by the participant or legal representative
You will not qualify if you...
- Serious systemic diseases
- Any eye disease affecting vision or refractive error
- History of manifest strabismus, amblyopia, or other ocular pathological changes
- Acute eye inflammation, active infection, or history of chronic or recurrent ocular inflammation
- Best corrected distance visual acuity in both eyes less than 4.9
- Abnormal intraocular pressure above 21 mmHg or difference greater than 5 mmHg between eyes
- Current or previous myopia control treatments including drugs or special lenses
- Use of medications interfering with study efficacy within 3 months
- Allergy or sensitivity to atropine, excipients, cyclopentolate, or fluorescein sodium
- Eye examination abnormalities making treatment unsuitable per investigator's judgment
- Participation in drug trials within 3 months or device trials within 1 month
- Expected long-term use of ocular or systemic corticosteroids during the study
- Other conditions deemed unsuitable for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
Z
Zhenjiang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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