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Recruiting NCT06151587

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

Phase III Interventional Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLM3004 Concentration 1, QLM3004 Concentration 2, QLM3004 Concentration 3, Placebo.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Drug QLM3004 Concentration 1
    Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
  • Drug QLM3004 Concentration 2
    Medium dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
  • Drug QLM3004 Concentration 3
    High dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
  • Other Placebo
    Vehicle

Primary outcome measures

  • Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96. [Time frame: 96 week]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Affiliated Eye Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT06151587 · QLM3004-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗