The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression
1 other identifier
interventional
606
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2024
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2024
CompletedFirst Submitted
Initial submission to the registry
November 20, 2024
CompletedFirst Posted
Study publicly available on registry
November 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
December 24, 2024
December 1, 2024
2.5 years
November 20, 2024
December 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effective change from baseline in equivalent spherical refraction at Week 96 visit
The inter-group difference in the value of change from baseline in equivalent spherical refraction after 0.01% or 0.02% atropine sulfate eye drops versus placebo under a cycloplegia condition at the Week 96 visit
At the Week 96 visit
Secondary Outcomes (9)
Effective change from baseline in eye axis length at 24 months
At the Week 96 visit
Effective change from baseline in refraction at 12 months
At the Week 48 visit
Effective change from baseline in ocular axis length at 12 months
At the Week 48 visit
Progression of refraction ≤0.50 D at 12 months and 24 months and percentage
At the Week 48 and Week 96 visits
Progression of refraction ≤0.75D at 12 months and 24 months and percentage
At the Week 48 and Week 96 visits
- +4 more secondary outcomes
Study Arms (3)
Experimental group (0.01% atropine sulfate eye drops)
ACTIVE COMPARATOR1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Experimental group (0.02% atropine sulfate eye drops)
ACTIVE COMPARATOR1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Control group (placebo eye drops)
PLACEBO COMPARATOR1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Interventions
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: 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 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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- Allergic to this product or its excipients.
- Suffering from eye diseases that may affect vision (e.g. lens diseases such as cataracts, glaucoma, fundus macular disease, keratopathy, uveitis, retinal detachment, severe vitreous opacity, etc., manifest strabismus, nystagmus, ocular acute inflammatory disease), history of recurrent chronic ocular inflammation, or any other ocular pathology (e.g., angular stenosis, shallow anterior chamber).
- Intraocular pressure of either eye is \> 21 mmHg or \<10 mmHg at screening.
- Use of low-concentration (0.05% and below) atropine sulfate eye drops (including various in-hospital preparations, except for test drugs) and orthokeratology lenses (OK lenses) within 6 months before the screening.
- Use of other myopia control methods such as instruments (multifocal glasses, progressive multifocal glasses, etc.), medications (the use of cycloplegic agents for examinations such as optometry is allowed), and others (including traditional Chinese medicine, auricular acupuncture, massage, accommodative flippers, red light therapy instrument, etc.) within 3 months before screening.
- Those who have participated in other clinical trials and received drug or medical device interventions within 3 months before screening.
- Systemic or topical use of drugs that affect the efficacy evaluation, such as anticholinergics: atropine, pirenzepine, etc., and cholinomimetics: pilocarpine, etc. within 1 week before screening.
- Combined with severe immune system disease, central nervous system disease, Down syndrome, asthma, cardiopulmonary insufficiency, liver and kidney dysfunction, etc.
- Surgical intervention (ocular or systemic) within 6 months before screening, or planned surgery during the study.
- Heart rate sustained (more than 10 minutes) greater than 120 beats/min at screening (after 10 minutes of rest if the ECG shows a heart rate greater than 120 beats per minute, the ECG should be retested 10 minutes later. If the retest result below 120 beats/min, the screening is successful; If the retest result is still \>120 beats/min, screening failed).
- Need for ocular use or systemic oral corticosteroids during the study. Intranasal, inhaled, topical cutaneous, intra-articular, perianal steroids, and short-term oral steroids (i.e., continuous use for \< 2 weeks).
- Other conditions that are considered unsuitable by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oupushifang Pharmaceutical Technology Co., Ltd.lead
- Seefunge Pharmaceutical Technology Co., Ltd.collaborator
- AUTEK China Inc.collaborator
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ningli Wang, Postdoctoral
Beijing Tongren Hospital Affiliated to Capital Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Masking aims to achieve the unpredictability of randomized treatment groups by all parties involved in a clinical trial. To reduce the influence of evaluation bias or other factors, a double-blind experimental design was adopted in this study. Placebo is the auxiliary ingredient of atropine sulfate eye drops, and its specification, color, smell, etc. are consistent with the test drug and do not contain the active ingredient of the test drug. The drug in the experimental group was packaged in the same packaging as the placebo, and blinded according to random numbers to ensure that both the investigator and the subject were masked.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2024
First Posted
November 27, 2024
Study Start
June 15, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
December 24, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share