The clinical trial aims to test the effectiveness and safety of two low-dose atropine sulfate eye drops for delaying myopia progression in children and adolescents. Primary Objective: evaluate the effectiveness of 0.01% and 0.02% atropine sulfate eye drops for 96 weeks compared to placebo in delaying myopia progression in children and adolescents. Secondary Objective: evaluate the safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) in delaying myopia progression in children and adolescents. Exploratory Objective: 1. the efficacy and safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) for 144 weeks. 2. evaluate the rebound effect of two low-concentration atropine sulfate eye drops (0.01%/0.02%) after discontinuation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
606
Drug: 0.01% atropine sulfate eye drops Dosage form and strength: 0.01% (0.4 mL: 0.04 mg) eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Drug: 0.02% atropine sulfate eye drops Dosage form and strength: 0.02% (0.4 mL: 0.08 mg) eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Drug: placebo eye drops Dosage form and strength: 0.4 mL eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Hefei Maternal and Child Health Hospital
Hefei, Anhui, China
RECRUITINGThe Second Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGXuancheng People's Hospital
Xuancheng, Anhui, China
RECRUITINGThe Second Hospital of Lanzhou University
Lanzhou, Gansu, China
RECRUITINGLiuzhou People's Hospital
Liuchow, Guangxi, China
RECRUITINGThe People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
RECRUITINGThe Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITINGThe First People's Hospital of Zunyi
Zunyi, Guizhou, China
RECRUITINGDaqingshi People's Hospital
Daqing, Heilongjiang, China
RECRUITINGKaifeng Central Hospital
Kaifeng, Henan, China
RECRUITING...and 15 more locations
Effective change from baseline in equivalent spherical refraction at Week 96 visit
The inter-group difference in the value of change from baseline in equivalent spherical refraction after 0.01% or 0.02% atropine sulfate eye drops versus placebo under a cycloplegia condition at the Week 96 visit
Time frame: At the Week 96 visit
Effective change from baseline in eye axis length at 24 months
Value of change from baseline in eye axis length at 24 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Time frame: At the Week 96 visit
Effective change from baseline in refraction at 12 months
Change from baseline in refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) at 12 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Time frame: At the Week 48 visit
Effective change from baseline in ocular axis length at 12 months
Change from baseline in ocular axis length at 12 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Time frame: At the Week 48 visit
Progression of refraction ≤0.50 D at 12 months and 24 months and percentage
Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤0.50 D at 12 months and 24 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Time frame: At the Week 48 and Week 96 visits
Progression of refraction ≤0.75D at 12 months and 24 months and percentage
Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤0.75D at 12 months and 24 months and percentage (0.02% atropine vs placebo; 0.01% atropine vs placebo)
Time frame: At the Week 48 and Week 96 visits
Progression of refraction ≤1.00D at 12 months and 24 months and percentage
Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤1.00D at 12 months and 24 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Time frame: At the Week 48 and Week 96 visits
Progression of refraction >1.00D at 12 months and 24 months and percentage
Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) \>1.00D at 12 months and 24 months of dosing and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Time frame: At the Week 48 and Week 96 visits
Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months
Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months of medication compared to control (0.02% atropine versus placebo; 0.01% atropine versus placebo)
Time frame: At the Week 48 and Week 96 visits
Change from baseline in other ocular morphologic measures at 12 months and 24 months
Change from baseline in other ocular morphologic measures (e.g., corneal curvature, vitreous chamber depth, choroidal thickness) at 12 months and 24 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Time frame: At the Week 48 and Week 96 visits
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