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他克莫司滴眼液治疗Sjogren’s综合征相关干眼的疗效及安全性的多中心研究
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注册号:

Registration number:

ChiCTR-IPR-17013772 

最近更新日期:

Date of Last Refreshed on:

2017-12-08 

注册时间:

Date of Registration:

2017-12-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

他克莫司滴眼液治疗Sjogren’s综合征相关干眼的疗效及安全性的多中心研究 

Public title:

A Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry Eye  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

他克莫司滴眼液治疗Sjogren’s综合征相关干眼的疗效及安全性的多中心研究 

Scientific title:

A Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry Eye  

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:

林威 

研究负责人:

陈蔚 

Applicant:

Wei Lin 

Study leader:

Wei Chen 

申请注册联系人电话:

Applicant telephone:

+86 13587560390 

研究负责人电话:

Study leader's telephone:

+86 13757728118 

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:

linweiysg@163.com 

研究负责人电子邮件:

Study leader's E-mail:

chenweimd@hotmail.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:

浙江省温州市鹿城区学院西路270号 

研究负责人通讯地址:

浙江省温州市鹿城区学院西路270号 

Applicant address:

270 Xueyuan Road West, Wenzhou, Zhejiang, China  

Study leader's address:

270 Xueyuan Road West, Wenzhou, Zhejiang, China  

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:

温州医科大学附属眼视光医院 

Applicant's institution:

The Eye Hospital of Wenzhou Medical University  

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2017-9 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

温州医科大学附属眼视光医院伦理委员会 

Name of the ethic committee:

Ethics Committee of The Eye Hospital of Wenzhou Medical University  

伦理委员会批准日期:

Date of approved by ethic committee:

2017-12-07 

伦理委员会联系人:

王晨晓 

Contact Name of the ethic committee:

Chenxiao Wang 

伦理委员会联系地址:

浙江省温州市学院西路270号温州医科大学附属眼视光医院伦理委员会办公室 

Contact Address of the ethic committee:

The office of Ethics Committee of The Eye Hospital of Wenzhou Medical University, 270 Xueyuan Road West, Wehzhou, Zhejiang, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

温州医科大学附属眼视光医院 

Primary sponsor:

The Eye Hospital of Wenzhou Medical University  

研究实施负责(组长)单位地址:

浙江省温州市学院西路270号 

Primary sponsor's address:

270 Xueyuan Road West, Wehzhou, Zhejiang, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

温州

Country:

China

Province:

Zhejiang

City:

单位(医院):

温州医科大学附属眼视光医院

具体地址:

浙江省温州市鹿城区学院西路270号

Institution
hospital:

The Eye Hospital of Wenzhou Medical University

Address:

270 Xueyuan Road West, Wenzhou, Zhejiang, China

经费或物资来源:

国家自然科学基金配套经费 

Source(s) of funding:

Supporting funds of the National Natural Science Foundation of China 

研究疾病:

Sjogren’s综合征相关干眼 

Target disease:

Sjogren's Syndrome Dry Eye  

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

评估他克莫司滴眼液治疗Sjogren’s综合征相关干眼的疗效及安全性 

Objectives of Study:

to evaluate safety and efficacy of tacrolimus eye drop in Sjogrens syndrome dry Eye  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)≥18周岁男女不限 2) 根据欧洲诊断标准诊断为Sj?grens综合征 3) 诊断为中至重度干眼病 a)EDS评分即眼干燥评分(0-100分的VAS评分)≥40分 b)泪膜破裂时间(BUT)≤5s c)Schirmer试验(表麻)≤5mm/5min d)存在任一区域角膜荧光素染色≥2分, 且中央角膜荧光素染分评分≥2分, 下方角膜荧光素染色评分≥1分 

Inclusion criteria

1. Aged≥18 years; 2. Sjogrens syndrome (SS) was diagnosed according to the SS European Criteria; 3 moderate to severe dry eye; (1) eye dryness score (EDS) ≥ 40 (VAS, 0-100); (2) BUT ≤ 5s; (3) Schirmer I test (anesthesia) ≤ 5mm/5min; (4) corneal fluorescein staining score (CFS) ≥ 2 in any zone of cornea, CFS ≥ 2 in central cornea and CFS ≥ 1 in inferior cornea. 

排除标准:

1)任何眼部解剖异常(眼睑瘢痕,睑内翻等); 2)青光眼病史; 3)不愿意避免佩戴隐形眼镜的患者; 4)研究开始前12个月内接受过内眼手术; 5)眼部感染; 6)全身使用免疫抑制剂或者大剂量激素患者 7)妊娠期及哺乳期女性 

Exclusion criteria:

1) any structural abnormalities (lid scarring, entropion, trichiasis, etc.); 2) glaucoma; 3) contact lens wearer; 4) intraocular surgery within 12months; 5) ocular infection; 6) current use of systemic immunosuppressants or large doses of steriods; 7) pregnant or lactating women. 

研究实施时间:

Study execute time:

From2018-01-01To 2018-06-01 

征募观察对象时间:

Recruiting time:

From2018-01-01To 2018-06-01 

干预措施:

Interventions:

组别:

他克莫司滴眼液组

样本量:

30

Group:

group of tacrolimus eye drops

Sample size:

干预措施:

他克莫司滴眼液

干预措施代码:

Intervention:

tacrolimus eye drops

Intervention code:

组别:

氟米龙滴眼液组

样本量:

30

Group:

group of flurometholone eye drops

Sample size:

干预措施:

氟米龙滴眼液

干预措施代码:

Intervention:

flurometholone eye drops

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

温州医科大学附属眼视光医院 

单位级别:

三级甲等 

Institution
hospital:

The Eye Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

台州 

Country:

China 

Province:

Zhejiang 

City:

Taizhou 

单位(医院):

台州医院 

单位级别:

三级甲等 

Institution
hospital:

Taizhou Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

宁波 

Country:

China 

Province:

Zhejiang 

City:

Ningbo 

单位(医院):

鄞州人民医院 

单位级别:

三级乙等 

Institution
hospital:

Yinzhou people's Hospita  

Level of the institution:

Tertiary B hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海爱尔眼科医院 

单位级别:

二级甲等 

Institution
hospital:

ShangHai Aier Eye Hospital  

Level of the institution:

Secondary A hospital  

测量指标:

Outcomes:

指标中文名:

眼干燥评分

指标类型:

主要指标 

Outcome:

eye dryness score (EDS)

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼表疾病指数量表

指标类型:

次要指标 

Outcome:

Ocular Surface Disease Index (OSDI)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

泪膜破裂时间

指标类型:

次要指标 

Outcome:

BUT

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角膜荧光素染色

指标类型:

次要指标 

Outcome:

corneal fluorescein staining

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Schirmer试验(表麻)

指标类型:

次要指标 

Outcome:

Schirmer I test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

眼压

指标类型:

次要指标 

Outcome:

intraocular pressure (IOP)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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 years
最大 Max age 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):

药物管理者采用Excel生成随机数(0或1)

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

administrator of drugs make random number (0 or 1) by Excel

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

还未公开,未定

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

Undecided

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:

病例记录表

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-12-08
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