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RECRUITING
NCT06708156
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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