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New treatment option for Myopia
Official title A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children
ClinicalTrials.gov ID: NCT06151587
What this study is testing
What is QLM3004 Concentration 1?
QLM3004 Concentration 1 is an investigational medicine, being studied as a potential treatment for myopia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Efficacy and Safety Study of QLM3004 in Myopic Children
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12
You may be able to join if
- 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 people and/or their legal representatives
You likely can't join if
- 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...
- Best corrected distance visual acuity in both eyes\<4.9
- Abnormal intra-ocular pressure (\>21 mmHg or difference between two eyes \>5mmHg)
See the full eligibility 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 people and/or their legal representatives
- 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 how well it works 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
The study team makes the final eligibility decision.
Where it's taking place
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.