Actively Recruiting
The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression
Led by Oupushifang Pharmaceutical Technology Co., Ltd. · Updated on 2024-12-24
606
Participants Needed
25
Research Sites
184 weeks
Total Duration
On this page
Sponsors
O
Oupushifang Pharmaceutical Technology Co., Ltd.
Lead Sponsor
S
Seefunge Pharmaceutical Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The legal guardian has signed informed consent; subjects over 8 years also sign consent
- Age between 6 and 12 years inclusive
- Myopia with equivalent spherical refraction between -1.00 D and -4.00 D in both eyes under cycloplegia
- Astigmatism ≤ 1.50 D in both eyes under cycloplegia
- Antimetropia less than 2.00 D at screening
- Ability to comply with study requirements and attend all visits including telephone follow-ups
- Willingness to be randomly assigned to atropine treatment or placebo
You will not qualify if you...
- Allergy to the study product or its ingredients
- Eye diseases affecting vision such as cataracts, glaucoma, macular disease, keratopathy, uveitis, retinal detachment, severe vitreous opacity, strabismus, nystagmus, or ocular inflammation
- Intraocular pressure > 21 mmHg or < 10 mmHg at screening
- Use of low-concentration atropine eye drops (≤ 0.05%) or orthokeratology lenses within 6 months before screening
- Use of other myopia control methods (e.g., multifocal glasses, medications other than cycloplegic agents, traditional Chinese medicine, acupuncture) within 3 months before screening
- Participation in other clinical trials with drug or device interventions within 3 months before screening
- Use of drugs affecting efficacy evaluation such as anticholinergics or cholinomimetics within 1 week before screening
- Severe systemic diseases including immune, central nervous system, Down syndrome, asthma, cardiopulmonary, liver or kidney dysfunction
- Surgical intervention within 6 months before screening or planned surgery during the study
- Sustained heart rate > 120 beats/min at screening after rest
- Need for ocular or systemic corticosteroids during the study (except certain short-term uses)
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Hefei Maternal and Child Health Hospital
Hefei, Anhui, China
Actively Recruiting
2
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
3
Xuancheng People's Hospital
Xuancheng, Anhui, China
Actively Recruiting
4
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Actively Recruiting
5
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Actively Recruiting
6
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Actively Recruiting
7
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Actively Recruiting
8
The First People's Hospital of Zunyi
Zunyi, Guizhou, China
Actively Recruiting
9
Daqingshi People's Hospital
Daqing, Heilongjiang, China
Actively Recruiting
10
Kaifeng Central Hospital
Kaifeng, Henan, China
Actively Recruiting
11
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Actively Recruiting
12
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Actively Recruiting
13
Affiliated Eye Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
14
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
15
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
16
Weifang Eye Hospital
Weifang, Shandong, China
Actively Recruiting
17
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Actively Recruiting
18
Shanxi Eye Hospital
Taiyuan, Shanxi, China
Actively Recruiting
19
Xianyang Hospital of Yan'an University
Xianyang, Shanxi, China
Actively Recruiting
20
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
21
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, China
Actively Recruiting
22
Peking University Third Hospital
Beijing, China
Actively Recruiting
23
Chongqing Aier Eye Hospital
Chongqing, China
Actively Recruiting
24
Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital)
Shanghai, China
Actively Recruiting
25
Tianjin Medical University Eye Hospital
Tianjin, China
Actively Recruiting
Research Team
L
Liang Gao
CONTACT
S
Shaolong XUE, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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