This study was a randomized, double-blind, placebo-controlled, multicenter, superiority design, phase III clinical trial to compare the efficacy and safety of two low-concentration atropine sulfate eye drops versus placebo in delaying myopia progression in children.
Eligible subjects were screened and randomly assigned to the placebo control group, the lower dose group, and the lower dose group. Subjects received the study drug in both eyes, 1 drop each time, once every night before sleep, for continuous administration.A total of 526 subjects were planned to be enrolled。 Statistical analyses were performed with the use of SAS software, version 9.4, without any specific description. All statistical tests were two-sided at a 0.05 level.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
526
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Cycloplegic Autorefraction(low)
Group difference in the proportion of subjects eyes with myopia progression (SER) less than -0.50 D at M12 visit with low atropine versus placebo.
Time frame: twelve months
Cycloplegic Autorefraction(lower)
Group difference in the proportion of subjects eyes with myopia progression (SER) less than -0.50 D at M12 visit with lower atropine versus placebo.
Time frame: twelve months
Cycloplegic Autorefraction(SER)
Between-group difference in the mean change from baseline in SER at visit M12
Time frame: twelve months
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