Myopia
Conditions
Brief summary
Efficacy and Safety Study of QLM3004 in Myopic Children
Detailed description
The study was divided into 2 phases, with Stage 1 being the primary efficacy and safety confirmation phase and Stage 2 a post-withdrawal observation period. 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.
Interventions
DRUGQLM3004 Concentration 1
Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
DRUGQLM3004 Concentration 2
Medium dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
DRUGQLM3004 Concentration 3
High dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
OTHERPlacebo
Vehicle
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96. | 96 week | Effectiveness Evaluation |
Countries
China
Contacts
Primary ContactZhenjiang Wang
Outcome results
None listed