ChiCTR2500106942 版本V1.0 版本创建时间2025/07/31 18:31:22 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500106942 

最近更新日期：

Date of Last Refreshed on：

2025-07-31 18:31:14 

注册时间：

Date of Registration：

2025-07-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价地巴唑滴眼液雾化控制儿童青少年近视进展的有效性和安全性的随机、开放、非劣效性对照临床试验

Public title：

A randomized, open-label, non-inferiority controlled clinical trial to evaluate the effectiveness and safety of dibazole eye drops in the control of myopia progression in children and adolescents

注册题目简写：

地巴唑滴眼液雾化控制近视进展的有效性和安全性的研究

English Acronym：

Efficacy and safety of dibazole eye drops atomization treatment for control of myopia progression

研究课题的正式科学名称：

评价地巴唑滴眼液雾化控制儿童青少年近视进展的有效性和安全性的随机、开放、非劣效性对照临床试验

Scientific title：

A randomized, open-label, non-inferiority controlled clinical trial to evaluate the effectiveness and safety of dibazole eye drops in the control of myopia progression in children and adolescents

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

魏士飞 

研究负责人：

王宁利 

Applicant：

Shifei Wei 

Study leader：

wangningli 

申请注册联系人电话：

Applicant telephone：

+86 188 0119 9912

研究负责人电话：

Study leader's telephone：

+86 10 5826 5922

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

wsfstep2015@163.com

研究负责人电子邮件：

Study leader's E-mail：

wningli@vip.163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市东城区东交民巷1号

研究负责人通讯地址：

北京市东城区东交民巷1号北京同仁医院

Applicant address：

NO 1, Dong Jiao Min Xiang, Eastern District, Beijing, China

Study leader's address：

NO.1 Dongjiaominxiang Street, Dongchen District,Beijing

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

首都医科大学附属北京同仁医院

Applicant's institution：

Beijing Tongren Hospital

研究负责人所在单位：

首都医科大学附属北京同仁医院

Affiliation of the Leader：

Bejing Tongren Hospital, Capital Medical Uniersity

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

TREC2025-KY142

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

首都医科大学附属北京同仁医院伦理委员会

Name of the ethic committee：

Ethics Committee of Beijing Tongren Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-07-01 00:00:00

伦理委员会联系人：

武峰

Contact Name of the ethic committee：

Wu Feng

伦理委员会联系地址：

北京市东城区东交民巷1号北京同仁医院

Contact Address of the ethic committee：

NO.1 Dongjiaominxiang Street, Dongchen District,Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 5826 8422

伦理委员会联系人邮箱：

Contact email of the ethic committee：

bjtrec@126.com

研究实施负责（组长）单位：

首都医科大学附属北京同仁医院

Primary sponsor：

Bejing Tongren Hospital, Capital Medical Uniersity

研究实施负责（组长）单位地址：

北京市东城区东交民巷1号北京同仁医院

Primary sponsor's address：

NO.1 Dongjiaominxiang Street, Dongchen District,Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

首都医科大学附属北京同仁医院

具体地址：

北京市东城区东交民巷1号北京同仁医院

Institution
hospital：

Bejing Tongren Hospital, Capital Medical Uniersity

Address：

NO.1 Dongjiaominxiang Street, Dongchen District,Beijing

经费或物资来源：

四川禾亿制药有限公司

Source(s) of funding：

Sichuan HeYi Pharmaceutical Co.

Target disease：

Myopia

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 II期临床试验 

Study phase：

2

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本试验是一项评价地巴唑滴眼液雾化控制青少年近视进展的有效性和安全性的随机、开放、非劣效性对照临床试验。整个研究持续1年。设α=0.05，β=0.10 即把握度为90%，失访率为20%。根据既往研究結果，期望用药一年后两组之同的屈光度迸展量差別在0.40D以上有意义，标准差为0.50D，则样本量为：N=2*（1.96+1.28）2*（0.50）2/(0.40）2=32，考虑到20%失访率，每组需40人，两组共80人。计划入组80例（人）受试者，按照1:1比例受试者随机接受地巴唑滴眼液雾化组和阿托品滴眼液组。  

Objectives of Study：

This trial is a randomised, open, non-inferiority controlled clinical trial evaluating the efficacy and safety of nebulised diprazole eye drops in controlling the progression of myopia in adolescents. The entire study lasted for 1 year. Let α=0.05 and β=0.10, i.e. 90% certainty and 20% failure rate. According to the results of previous studies, it is expected that the difference in the amount of refractive error between the two groups after one year of drug use is more than 0.40D, with a standard deviation of 0.50D. The sample size is: N=2*(1.96+1.28)2*(0.50)2/(0.40)2=32, taking into account 20% loss of follow-up rate, 40 people are needed for each group, and there are a total of 80 people in the two groups. It was planned to enroll 80 (human) subjects, and in a 1:1 ratio, subjects were randomised to receive Dibazole eye drops nebulised group and Atropine eye drops group.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄6~12周岁（含6周岁、12周岁）；
2.睫状肌麻痹验光屈光度（等效球镜度）介于-0.50D到-4.50D（包含边界值），且柱镜度≤-1.50D（单眼符合也可入组）；
3.双眼屈光参差＜2.00D（球镜差＜1.50D，柱镜差＜1.00D）；
4.双眼最佳矫正视力为0.8或更佳；
5.双眼角膜曲率40.00～46.00D；
6.眼压10～20mmHg；
7.获得法定监护人的知情同意，孩子的知情同意，并能按照方案要求进行的试验者；

Inclusion criteria

1.Age 6~12 years old (including 6 years old and 12 years old); 2.Cycloplegia refraction (equivalent spherical diopter) is between -0.50D to -4.50D (including the boundary value), and the cylinder diopter is <= -1.50D (monoocular compliance can also be included in the group); 3.Binocular anisometropia <2.00D (spherical aberration <1.50D, cylindrical aberration <1.00D); 4.The best corrected visual acuity of both eyes is 0.8 or better; 5.Corneal curvature of both eyes is 40.00-46.00D; 6.Intraocular pressure 10~20mmHg; 7.Those who have obtained the informed consent of the legal guardian, the informed consent of the child, and who can conduct the experiment according to the requirements of the program;

排除标准：

1.地巴唑过敏和（或）单疱病毒感染者；
2.阿托品过敏和（或）青光眼及青光眼倾向、对莨菪碱成分过敏、儿童脑外伤者；
3.任一眼有影响视力或屈光不正的眼部疾病（如白内障等晶状体损伤疾病、显性斜视、青光眼、角膜病变、黄斑病变、色素膜炎、视网膜脱离、严重玻璃体混浊、眼睑下垂等）；
4.任一眼有活动性眼周或眼部炎症（例如：睑缘炎、感染性结膜炎、角膜炎、巩膜炎、葡萄膜炎、眼内炎）；
5.可能影响屈光发育的全身状况者（例如唐氏综合症，马方氏综合症）；
6.任一眼有≥0.50D的远视者；
7.任一眼有圆锥角膜等角膜曲率异常者；
8.有不受控的全身性疾病或衰竭性疾病及免疫力缺陷的患者；
9.筛选前4周接受眼部手术者；
10.筛选前4周内参与其他药物或器械临床研究者；
11.入组前6个月内使用过除单焦框架眼镜以外的近视控制治疗方法，药物治疗：如阿托品或哌仑西平等；器械治疗：角膜塑形镜、多焦软镜、多焦硬镜、功能性框架眼镜者；
12.回访依从性差者；
13.在完成最终研究评价之前计划有其他眼科操作者；
14.筛选前4周内或试验期间使用近视乐、夏天无滴眼液等同适应症药物；
15.干眼或睑板腺功能障碍者；
16.存在研究者认为不适合参加本研究的其他情况；

Exclusion criteria：

1.People who are allergic to dibazole and (or) herpes simplex virus infection; 2.People with atropine allergy and/or glaucoma and glaucoma predisposition, allergy to scopolamine components and with traumatic brain injury; 3.Eye diseases affecting vision or refractive error (such as cataract and other lens damage diseases, dominant strabismus, glaucoma, keratopathy, macular degeneration, uveitis, retinal detachment, severe vitreous opacity, ptosis, etc.); 4.Active periocular or ocular inflammation in either eye (eg, blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis); 5.Persons with systemic conditions that may affect refractive development (eg Down syndrome, Marfan syndrome); 6.Hyperopia with >= 0.50D in either eye; 7.Those with abnormal corneal curvature such as keratoconus in any eye; 8.Patients with uncontrolled systemic disease or debilitating disease and immunodeficiency; 9.Those who received eye surgery 4 weeks before screening; 10.Participate in clinical investigators of other drugs or devices within 4 weeks before screening; 11.Use of myopia control treatment methods other than monofocal frame glasses within 4 weeks before enrollment, drug treatment: such as atropine or pirenzepine; device treatment: orthokeratology lens, multifocal soft lens, multifocal hard lens Glasses, functional frame glasses; 12.Those with poor compliance with return visits; 13.Plan to have other ophthalmic operators before completing the final study evaluation; 14.Myopia and Xianwu eye drops are used within 4 weeks before screening or during the trial; 15.Dry eye or Meibomian gland dysfunction; 16.There are other circumstances that the investigator considers unsuitable to participate in this study;

研究实施时间：

Study execute time：

从 From 2025-08-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-08-01 00:00:00 至 To 2025-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

40

Group：

test group

Sample size：

干预措施：

地巴唑滴眼液雾化

干预措施代码：

Intervention：

Dibazole eye drops nebulized

Intervention code：

组别：

对照组

样本量：

40

Group：

control group

Sample size：

干预措施：

0.01%阿托品滴眼液直接滴眼

干预措施代码：

Intervention：

0.01% atropine eye drops

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

首都医科大学附属北京同仁医院 

单位级别：

三级甲等 

Institution
hospital：

Bejing Tongren Hospital, Capital Medical Uniersity

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

泪膜破裂时间（BUT）

指标类型：

次要指标

Outcome：

Tear Break-Up Time(BUT)

Type：

Secondary indicator

测量时间点：

用药后3月±2周、6月±2周、1年±2周进行

测量方法：

灭菌滴管吸取1%荧光素钠溶液（2μL）滴于结膜囊，患者瞬目3-4次使荧光素涂布于眼表，双眼平视前方，从末次瞬目至角膜出现首个黑斑的时间，测量3次取平均值。

Measure time point of outcome：

After 3months+- 2weeks, 6months+- 2weeks, 1 year+- 2 weeks of medication

Measure method：

A sterilised dropper was used to aspirate 1% sodium fluorescein solution (2 μL) into the conjunctival sac, the patient transiently glanced 3-4 times so that the fluorescein was coated on the ocular surface, and both eyes were looked at flatly in front of the eyes, the time from the last transient glance to the appearance of the first black spot on the cornea was measured three times to take the average value.

指标中文名：

睫状肌麻痹验光屈光度（等效球镜度）

指标类型：

主要指标

Outcome：

Spherical Equivalent(SE)

Type：

Primary indicator

测量时间点：

用药1年±2周后进行

测量方法：

使用1.0%环喷托酯滴眼液。先使用表面麻醉剂点眼1次，2~3min后再使用1.0%环喷托酯滴眼液，每5min使用1次，至少使用3次；在1.0%环喷托酯滴眼液最后1次点眼至少30min后进行电脑验光。睫状肌麻痹后检测的屈光度以等效球镜度(spherical equivalent refraction，SER)表示，SER=球镜度数+1/2×柱镜度数。 电脑验光的操作规范：左右眼分别测量3个读数，取平

Measure time point of outcome：

After 1 year +-2 weeks of medication

Measure method：

Use 1.0% cyclopentolate eye drops. Use topical anesthetics for one eye instillation first, then use 1.0% cyclopentolate eye drops every 5 minutes, at least 3 times; in the last eye drop of 1.0% cyclopentolate eye drops at least Computer optometry was performed after 30 minutes. The diopter detected after cycloplegia was expressed as spherical equivalent refraction (SER), SER=spherical refraction+1/2×cylindrical refraction. Operating specifications for computer optometry: Measure 3 readings for t

指标中文名：

裸眼视力

指标类型：

次要指标

Outcome：

Uncorrected Visual Acuity(SC)

Type：

Secondary indicator

测量时间点：

用药后3月±2周、6月±2周、1年±2周进行

测量方法：

采用标准对数视力表，受检者在距视力表5m处，视力表的1.0行与受检者的眼睛位于同一高度。从最大一行标记开始，逐级将较小标记指给被检者看，直至查出能清楚辨认的最小一行标记。

Measure time point of outcome：

After 3months+- 2weeks, 6months+- 2weeks, 1 year+- 2 weeks of medication

Measure method：

A standard logarithmic visual acuity chart is used, with the subject at 5 m from the chart and row 1.0 of the chart at the same level as the subject's eyes. Starting with the largest row of markers, smaller markers are pointed out to the examinee in ascending order until the smallest row of markers that can be clearly recognised is identified.

指标中文名：

眼轴长度

指标类型：

次要指标

Outcome：

Axial Length

Type：

Secondary indicator

测量时间点：

用药后3月±2周、6月±2周、1年±2周进行

测量方法：

常瞳下使用生物测量仪(IOLMaster-7000蔡司) 进行测量，遮盖一眼，另一眼固视前方测量眼轴长度、角膜曲率及瞳孔直径，测3次取平均值

Measure time point of outcome：

After 3months+- 2weeks, 6months+- 2weeks, 1 year+- 2 weeks of medication

Measure method：

Measurements were made with a biometer (IOLMaster-7000 Zeiss) under normal pupils, with one eye covered and the other fixed in front to measure axial length, corneal curvature, and pupil diameter, and averaged three times.

指标中文名：

调节灵敏度

指标类型：

次要指标

Outcome：

Accommodative Sensitivity

Type：

Secondary indicator

测量时间点：

用药后3月±2周、6月±2周、1年±2周进行

测量方法：

使用综合验光仪对调节灵敏度进行检测。

Measure time point of outcome：

After 3months+- 2weeks, 6months+- 2weeks, 1 year+- 2 weeks of medication

Measure method：

Adjustment sensitivity was tested using a comprehensive optometrist.

指标中文名：

睫状肌麻痹验光屈光度（等效球镜度）

指标类型：

次要指标

Outcome：

Spherical Equivalent(SE)

Type：

Secondary indicator

测量时间点：

用药6月±2周后进行

测量方法：

使用1.0%环喷托酯滴眼液。先使用表面麻醉剂点眼1次，2~3min后再使用1.0%环喷托酯滴眼液，每5min使用1次，至少使用3次；在1.0%环喷托酯滴眼液最后1次点眼至少30min后进行电脑验光。睫状肌麻痹后检测的屈光度以等效球镜度(spherical equivalent refraction，SER)表示，SER=球镜度数+1/2×柱镜度数。 电脑验光的操作规范：左右眼分别测量3个读数，取平

Measure time point of outcome：

After 6months +-2 weeks of medication

Measure method：

Use 1.0% cyclopentolate eye drops. Use topical anesthetics for one eye instillation first, then use 1.0% cyclopentolate eye drops every 5 minutes, at least 3 times; in the last eye drop of 1.0% cyclopentolate eye drops at least Computer optometry was performed after 30 minutes. The diopter detected after cycloplegia was expressed as spherical equivalent refraction (SER), SER=spherical refraction+1/2×cylindrical refraction. Operating specifications for computer optometry: Measure 3 readings for t

指标中文名：

脉络膜厚度

指标类型：

次要指标

Outcome：

Choroidal thickness

Type：

Secondary indicator

测量时间点：

用药后3月±2周、6月±2周、1年±2周进行

测量方法：

采用光学相干断层扫描仪(OCT)测量SFCT，使用HD5线平行线扫描方式收集双眼OCT图像，并使用增强深度成像(enhanced depthimaging，EDI)模式调整扫描图像的信号比，使图像深部脉络膜巩膜界面的信号比增强，以优化脉络膜的可见度。检查由同一位操作员于每日9：00～14：00进行测量，根据既往研究，虽然脉络膜厚度存在昼夜节律，但在此期间脉络膜厚度无显著变化。获得OCT图像后，使用

Measure time point of outcome：

After 3months+- 2weeks, 6months+- 2weeks, 1 year+- 2 weeks of medication

Measure method：

SFCT was measured using optical coherence tomography (OCT), whereby OCT images were collected from both eyes using the HD5 line-parallel scanning modality, and the signal ratios of the scanned images were adjusted using enhanced depthimaging (EDI) modality to allow for enhanced signal ratios at the scleral interface of the deeper choroid of the image to optimise the visibility of the choroid. Examinations were measured by the same operator from 9:00 to 14:00 daily, and according to previous stud

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 6 岁 years
最大 Max age 12 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由统计师采用SPSS产生随机数

Randomization Procedure (please state who generates the random number sequence and by what method)：

Generate random numbers by statistician using SPSS

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

三盲（受试者盲、研究者盲、数据分析者盲）

Blinding：

The triple-blind design includes Blinding of Subjects，Researchers and Data Analysts

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

2028年1月后以学术论文发表形式公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Publicly available in the form of academic papers published after January 2028

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

1.病例报告表/电子数据记录 使用研究病例和CRF表进行原始数据记录和试验需要的数据的采集。采用双人数据录入的方式避免和减少数据录入错误。 2.数据管理 数据管理员进行数据审核，完成数据质疑后锁定数据库，进行统计分析。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

1. Case Report Forms/Electronic Data Records Use study cases and CRF forms for raw data recording and collection of data needed for the trial. Use two-person data entry to avoid and minimise data entry errors. 2. Data Management The data manager conducts data review and locks the database for statistical analysis after completing the data challenge.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

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  2025-07-31 18:31:14