Clinical trial NCT06151587: A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Myopia
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-30
Enrollment: 735
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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 outcomes:
measure: Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96.
timeFrame: 96 week
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Affiliated Eye Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
References: