Efficacy and Safety Study of QLM3004 in Myopic Children
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
735
Low dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
Medium dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
High dose of QLM3004 Ophthalmic Solution 1 drop in each eye at bedtime
The Affiliated Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGChange from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96.
Effectiveness Evaluation
Time frame: 96 week
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Vehicle