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
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:
• The legal guardian of the subject voluntarily signed the written informed consent, and the subject over 8 years is required to sign the written informed consent voluntarily.
• Patients with myopia aged 6 to 12 years, including cut-offs.
• The equivalent spherical refraction ranges from -1.00 D to -4.00 D (automatic optometry under a cycloplegia condition) in both myopia eyes at inclusion screening.
• The astigmatism of both eyes was ≤ 1.50 D under a cycloplegia condition at inclusion screening.
• The antimetropia (measured by equivalent spherical refraction) is \< 2.00 D at inclusion screening.
• Able to comply with study requirements, attend all study visits (including telephone visits), and be willing to receive random grouping of atropine treatment or placebo.
Locations
Other Locations
China
Beijing Tongren Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Heping Hospital Affiliated to Changzhi Medical College
RECRUITING
Changzhi
Chongqing Aier Eye Hospital
RECRUITING
Chongqing
Daqingshi People's Hospital
RECRUITING
Daqing
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Hefei Maternal and Child Health Hospital
RECRUITING
Hefei
The Second Hospital of Anhui Medical University
RECRUITING
Hefei
The First Affiliated Hospital of University of South China
RECRUITING
Hengyang
Huai'an First People's Hospital
RECRUITING
Huai'an
Kaifeng Central Hospital
RECRUITING
Kaifeng
The Second Hospital of Lanzhou University
RECRUITING
Lanzhou
Liuzhou People's Hospital
RECRUITING
Liuchow
Affiliated Eye Hospital of Nanchang University
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
The People's Hospital of Guangxi Zhuang Autonomous Region
RECRUITING
Nanning
Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital)
RECRUITING
Shanghai
Shanxi Eye Hospital
RECRUITING
Taiyuan
Tianjin Medical University Eye Hospital
RECRUITING
Tianjin
Weifang Eye Hospital
RECRUITING
Weifang
Xianyang Hospital of Yan'an University
RECRUITING
Xianyang
Xuancheng People's Hospital
RECRUITING
Xuancheng
The First People's Hospital of Zunyi
RECRUITING
Zunyi
Contact Information
Primary
Liang Gao
9071044822@qq.com
0086-15056564539
Backup
Shaolong XUE, Dr.
xuesl@seefunge.com
0086-18565027687
Time Frame
Start Date:2024-06-15
Estimated Completion Date:2027-12-31
Participants
Target number of participants:606
Treatments
Active_comparator: Experimental group (0.01% atropine sulfate eye drops)
1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Active_comparator: Experimental group (0.02% atropine sulfate eye drops)
1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Placebo_comparator: Control group (placebo eye drops)
1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.