The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression
NCT ID: NCT06708156
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
606 participants
INTERVENTIONAL
2024-06-15
2027-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients with myopia aged 6 to 12 years, including cut-offs.
3. 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.
4. The astigmatism of both eyes was ≤ 1.50 D under a cycloplegia condition at inclusion screening.
5. The antimetropia (measured by equivalent spherical refraction) is \< 2.00 D at inclusion screening.
6. 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.
Exclusion Criteria
2. 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).
3. Intraocular pressure of either eye is \> 21 mmHg or \<10 mmHg at screening.
4. 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.
5. 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.
6. Those who have participated in other clinical trials and received drug or medical device interventions within 3 months before screening.
7. 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.
8. Combined with severe immune system disease, central nervous system disease, Down syndrome, asthma, cardiopulmonary insufficiency, liver and kidney dysfunction, etc.
9. Surgical intervention (ocular or systemic) within 6 months before screening, or planned surgery during the study.
10. 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).
11. 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).
12. Other conditions that are considered unsuitable by the investigator.
6 Years
12 Years
ALL
No
Sponsors
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Seefunge Pharmaceutical Technology Co., Ltd.
INDUSTRY
AUTEK China Inc.
UNKNOWN
Oupushifang Pharmaceutical Technology Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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Ningli Wang, Postdoctoral
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital Affiliated to Capital Medical University
Locations
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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
Liuzhou, 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
Countries
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Central Contacts
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Facility Contacts
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Ruqin Zha
Role: primary
Liming Tao
Role: primary
Shenghua Dong
Role: primary
Wanna Ren
Role: primary
Xiaobo Wan
Role: primary
Qi Chen
Role: primary
Hao Gu
Role: primary
Wei Tan
Role: primary
Xingmin Wang
Role: primary
Hongmei Mu
Role: primary
Gang Tan
Role: primary
Chaopeng Li
Role: primary
Hongfei Liao
Role: primary
Xiaorong Wu
Role: primary
Xiaolong Yin
Role: primary
Xianyong Sun
Role: primary
Yun Cui
Role: primary
Junhong Li
Role: primary
Binke Yu
Role: primary
Lijun Shen
Role: primary
Feng Wu
Role: primary
Ningli Wang, Postdoctoral
Role: backup
Yueguo Chen
Role: primary
Yi Ren
Role: primary
Haidong Zou
Role: primary
Wei Xu
Role: backup
Lin Liu
Role: primary
Other Identifiers
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CTR20240786
Identifier Type: REGISTRY
Identifier Source: secondary_id
CTR20240786
Identifier Type: -
Identifier Source: org_study_id