Recruiting
Phase 3
A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children
Condition(s) studied
Myopia
Investigational drug(s) / intervention(s)
QLM3004 Concentration 1QLM3004 Concentration 2QLM3004 Concentration 3Placebo
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
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 |
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