A Phase 3 Clinical Study of QLM3004 in Delaying Myopia in Children
NCT ID: NCT06151587
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
735 participants
INTERVENTIONAL
2023-08-20
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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QLM3004 Concentration 1
Solution low dose
QLM3004 Concentration 1
Low dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime
QLM3004 Concentration 2
Solution medium dose
QLM3004 Concentration 2
Medium dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime
QLM3004 Concentration 3
Solution high dose
QLM3004 Concentration 3
High dose of QLM3004 Ophthalmic Solution
1 drop in each eye at bedtime
Placebo
Placebo Ophthalmic Solution
Placebo
Vehicle
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
12 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Affiliated Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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jia Qu, M.D.
Role: primary
Other Identifiers
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QLM3004-301
Identifier Type: -
Identifier Source: org_study_id