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The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression
Sponsor: Oupushifang Pharmaceutical Technology Co., Ltd.
Summary
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.
Official title: The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Progression of Myopia in Children and Adolescents in a Randomized, Double-blind, Placebo Parallel-controlled, Multicenter, Phase III Clinical Trial
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
606
Start Date
2024-06-15
Completion Date
2027-12-31
Last Updated
2024-12-24
Healthy Volunteers
No
Conditions
Interventions
Atropine sulfate eye drops 0.01%
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.
Atropine sulfate eye drops 0.02%
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.
Placebo eye drops
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.
Locations (25)
Hefei Maternal and Child Health Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Xuancheng People's Hospital
Xuancheng, Anhui, China
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The First People's Hospital of Zunyi
Zunyi, Guizhou, China
Daqingshi People's Hospital
Daqing, Heilongjiang, China
Kaifeng Central Hospital
Kaifeng, Henan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Affiliated Eye Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Weifang Eye Hospital
Weifang, Shandong, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Shanxi Eye Hospital
Taiyuan, Shanxi, China
Xianyang Hospital of Yan'an University
Xianyang, Shanxi, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, China
Peking University Third Hospital
Beijing, China
Chongqing Aier Eye Hospital
Chongqing, China
Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital)
Shanghai, China
Tianjin Medical University Eye Hospital
Tianjin, China