QLM3004 Concentration 1: Low dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime
QLM3004 Concentration 2: Medium dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime
QLM3004 Concentration 3: High dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime
Placebo: Vehicle
Study summary
Efficacy and Safety Study of QLM3004 in Myopic Children
Eligibility
Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96. — 96 week Effectiveness Evaluation
Trial sites (1)
Facility
City
Region
Status
The Affiliated Eye Hospital of Wenzhou Medical University
Wenzhou
Zhejiang
Recruiting
More Qilu Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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