The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression

PHASE3RecruitingINTERVENTIONAL
Enrollment

606

Participants

Timeline

Start Date

June 15, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
MyopiaMyopia Progression
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.

Trial Locations (25)

Unknown

RECRUITING

Hefei Maternal and Child Health Hospital, Hefei

RECRUITING

The Second Hospital of Anhui Medical University, Hefei

RECRUITING

Xuancheng People's Hospital, Xuancheng

RECRUITING

The Second Hospital of Lanzhou University, Lanzhou

RECRUITING

Liuzhou People's Hospital, Liuzhou

RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning

RECRUITING

The Affiliated Hospital of Guizhou Medical University, Guiyang

RECRUITING

The First People's Hospital of Zunyi, Zunyi

RECRUITING

Daqingshi People's Hospital, Daqing

RECRUITING

Kaifeng Central Hospital, Kaifeng

RECRUITING

The First Affiliated Hospital of University of South China, Hengyang

RECRUITING

Huai'an First People's Hospital, Huai'an

RECRUITING

Affiliated Eye Hospital of Nanchang University, Nanchang

RECRUITING

The First Affiliated Hospital of Nanchang University, Nanchang

RECRUITING

The Second Affiliated Hospital of Nanchang University, Nanchang

RECRUITING

Weifang Eye Hospital, Weifang

RECRUITING

Heping Hospital Affiliated to Changzhi Medical College, Changzhi

RECRUITING

Shanxi Eye Hospital, Taiyuan

RECRUITING

Xianyang Hospital of Yan'an University, Xianyang

RECRUITING

Zhejiang Provincial People's Hospital, Hangzhou

RECRUITING

Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing

RECRUITING

Peking University Third Hospital, Beijing

RECRUITING

Chongqing Aier Eye Hospital, Chongqing

RECRUITING

Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital), Shanghai

RECRUITING

Tianjin Medical University Eye Hospital, Tianjin

All Listed Sponsors
collaborator

Seefunge Pharmaceutical Technology Co., Ltd.

INDUSTRY

collaborator

AUTEK China Inc.

UNKNOWN

lead

Oupushifang Pharmaceutical Technology Co., Ltd.

OTHER

NCT06708156 - The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression | Biotech Hunter | Biotech Hunter