试验雷达 AI | ||
|---|---|---|
临床试验 NCT06708156 针对近视，近视进展目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression III期 606 儿科 青少年
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT06708156旨在研究治疗，主要针对近视，近视进展。这是一项III期 干预性研究试验，目前试验状态为招募中。试验始于2024年6月15日，计划招募606名患者。该研究由Oupushifang Pharmaceutical Technology Co., Ltd.主导，预计于2027年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年12月24日。
简要概括
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 atr...
显示更多官方标题
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
疾病
近视近视进展其他研究标识符
- CTR20240786
- CTR20240786 (注册标识符) (National Medical Products Administration, NMPA)
NCT编号
实际开始日期
2024-06-15
最近更新发布
2024-12-24
预计完成日期
2027-12-31
计划入组人数
606
研究类型
干预性研究
试验分期 (阶段)
III期
试验状态
招募中
关键词
Myopia
Atropine
Atropine
主要目的
治疗方法
分配方式
随机
干预模型
交叉设计
盲法
四盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照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. |
阳性对照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. |
安慰剂对照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. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Effective change from baseline in eye axis length at 24 months | Value of change from baseline in eye axis length at 24 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 96 visit |
Effective change from baseline in refraction at 12 months | Change from baseline in refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) at 12 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 visit |
Effective change from baseline in ocular axis length at 12 months | Change from baseline in ocular axis length at 12 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 visit |
Progression of refraction ≤0.50 D at 12 months and 24 months and percentage | Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤0.50 D at 12 months and 24 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 and Week 96 visits |
Progression of refraction ≤0.75D at 12 months and 24 months and percentage | Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤0.75D at 12 months and 24 months and percentage (0.02% atropine vs placebo; 0.01% atropine vs placebo) | At the Week 48 and Week 96 visits |
Progression of refraction ≤1.00D at 12 months and 24 months and percentage | Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤1.00D at 12 months and 24 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 and Week 96 visits |
Progression of refraction >1.00D at 12 months and 24 months and percentage | Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) \>1.00D at 12 months and 24 months of dosing and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 and Week 96 visits |
Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months | Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months of medication compared to control (0.02% atropine versus placebo; 0.01% atropine versus placebo) | At the Week 48 and Week 96 visits |
Change from baseline in other ocular morphologic measures at 12 months and 24 months | Change from baseline in other ocular morphologic measures (e.g., corneal curvature, vitreous chamber depth, choroidal thickness) at 12 months and 24 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 and Week 96 visits |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
6 Years
适龄性别
全部
- 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.
- 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.
- The astigmatism of both eyes was ≤ 1.50 D under a cycloplegia condition at inclusion screening.
- The antimetropia (measured by equivalent spherical refraction) is < 2.00 D at inclusion screening.
- 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.
- 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.
Oupushifang Pharmaceutical Technology Co., Ltd.- Seefunge Pharmaceutical Technology Co., Ltd.
- AUTEK China Inc.
研究中心联系人
联系人: Liang Gao, 0086-15056564539, [email protected]
联系人: Shaolong XUE, Dr., 0086-18565027687, [email protected]
25 位于 1 个国家/地区的研究中心
Anhui
Hefei Maternal and Child Health Hospital, Hefei, Anhui, China
Ruqin Zha, 联系人
招募中
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Liming Tao, 联系人
招募中
Xuancheng People's Hospital, Xuancheng, Anhui, China
Shenghua Dong, 联系人
招募中
Gansu
The Second Hospital of Lanzhou University, Lanzhou, Gansu, China
Wanna Ren, 联系人
招募中
Guangxi
Liuzhou People's Hospital, Liuchow, Guangxi, China
Xiaobo Wan, 联系人
招募中
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China
Qi Chen, 联系人
招募中
Guizhou
The Affiliated Hospital of Guizhou Medical University, Guiyang, Guizhou, China
Hao Gu, 联系人
招募中
The First People's Hospital of Zunyi, Zunyi, Guizhou, China
Wei Tan, 联系人
招募中
Heilongjiang
Daqingshi People's Hospital, Daqing, Heilongjiang, China
Xingmin Wang, 联系人
招募中
Henan
Kaifeng Central Hospital, Kaifeng, Henan, China
Hongmei Mu, 联系人
招募中
Hunan
The First Affiliated Hospital of University of South China, Hengyang, Hunan, China
Gang Tan, 联系人
招募中
Jiangsu
Huai'an First People's Hospital, Huai'an, Jiangsu, China
Chaopeng Li, 联系人
招募中
Jiangxi
Affiliated Eye Hospital of Nanchang University, Nanchang, Jiangxi, China
Hongfei Liao, 联系人
招募中
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Xiaorong Wu, 联系人
招募中
The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Xiaolong Yin, 联系人
招募中
Shandong
Weifang Eye Hospital, Weifang, Shandong, China
Xianyong Sun, 联系人
招募中
Shanxi
Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China
Yun Cui, 联系人
招募中
Shanxi Eye Hospital, Taiyuan, Shanxi, China
Junhong Li, 联系人
招募中
Xianyang Hospital of Yan'an University, Xianyang, Shanxi, China
Binke Yu, 联系人
招募中
Zhejiang
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Lijun Shen, 联系人
招募中
Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing, China
Feng Wu, 联系人, 0086-15910961255, [email protected]
Ningli Wang, Postdoctoral, 联系人
招募中
Peking University Third Hospital, Beijing, China
Yueguo Chen, 联系人
招募中
Chongqing Aier Eye Hospital, Chongqing, China
Yi Ren, 联系人
招募中
Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital), Shanghai, China
Haidong Zou, 联系人
Wei Xu, 联系人
招募中
Tianjin Medical University Eye Hospital, Tianjin, China
Lin Liu, 联系人
招募中