NCT06151587 A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children
| NCT ID | NCT06151587 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 735 participants |
| Start Date | 2023-08-20 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 735 participants in total. It began in 2023-08-20 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Efficacy and Safety Study of QLM3004 in Myopic Children
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06151587 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 12 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06151587 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 735 participants.
Is NCT06151587 currently recruiting?
Yes, NCT06151587 is actively recruiting participants. Contact the research team at zhenjiang.wang@qilu-pharma.com for enrollment information.
Where is the NCT06151587 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT06151587 clinical trial?
NCT06151587 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 735 participants.