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Clinical Trials in China / NCT06151587
Recruiting Phase 3

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

NCT06151587 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2023-08-20
Last updated
2023-11-30

Condition(s) studied

Myopia

Investigational drug(s) / intervention(s)

QLM3004 Concentration 1QLM3004 Concentration 2QLM3004 Concentration 3Placebo

QLM3004 Concentration 1: Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime

QLM3004 Concentration 2: Medium dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime

QLM3004 Concentration 3: High dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime

Placebo: Vehicle

Study summary

Efficacy and Safety Study of QLM3004 in Myopic Children

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The Affiliated Eye Hospital of Wenzhou Medical University Wenzhou Zhejiang Recruiting

More Qilu Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06151587 on ClinicalTrials.gov ↗ ← All trials in China