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โ† Trials
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A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children

RecruitingPhase 3Ages 6 Years - 12 YearsAllQilu Pharmaceutical Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

Efficacy and Safety Study of QLM3004 in Myopic Children

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค1.50 D in both eyes. * Anisometropia โ‰ค1.50 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
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What it tests

  • QLM3004 Concentration 1
  • QLM3004 Concentration 2
  • QLM3004 Concentration 3
  • Placebo
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Where

1 site
The Affiliated Eye Hospital of Wenzhou Medical University
Wenzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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