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

Study Overview
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Brief Summary
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Efficacy and Safety Study of QLM3004 in Myopic Children

Detailed Description
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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 efficacy of 3 concentrations of QLM3004 compared to Vehicle (placebo)for slowing the progression of myopia in children over a 96-week treatment period. Stage 2:subjects will enter Period 2 of the study, and Period 2 will be a post-withdrawal observation period, which will not serve as a validation basis for the efficacy and safety of QLM3004.

Official Title
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Different Concentrations of QLM3004 in Delaying the Progression of Myopia in Children

Conditions
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Myopia

Intervention / Treatment
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* Drug: QLM3004 Concentration 1
* Drug: QLM3004 Concentration 2
* Drug: QLM3004 Concentration 3
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLM3004 Concentration 1<br>Solution low dose | Drug: QLM3004 Concentration 1<br>* Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime<br>|
| Experimental: QLM3004 Concentration 2<br>Solution medium dose | Drug: QLM3004 Concentration 2<br>* Medium dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime<br>|
| Experimental: QLM3004 Concentration 3<br>Solution high dose | Drug: QLM3004 Concentration 3<br>* High dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime<br>|
| Placebo Comparator: Placebo<br>Placebo Ophthalmic Solution | Other: Placebo<br>* Vehicle<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96. | Effectiveness Evaluation | 96 week |