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0.1%他克莫司(FK506)治疗干燥综合征眼部临床疗效评价
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注册号:

Registration number:

ChiCTR-OIB-16007789 

最近更新日期:

Date of Last Refreshed on:

2016-01-18 

注册时间:

Date of Registration:

2015-12-30 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

0.1%他克莫司(FK506)治疗干燥综合征眼部临床疗效评价 

Public title:

0.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

0.1%他克莫司(FK506)治疗干燥综合征眼部临床疗效评价 

Scientific title:

0.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation 

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:

杨舒 

研究负责人:

刘祖国 

Applicant:

Shu Yang 

Study leader:

Zuguo Liu 

申请注册联系人电话:

Applicant telephone:

+86 13606935286 

研究负责人电话:

Study leader's telephone:

+86 18959289999 

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:

yangshujjx@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zuguoliu@xmu.edu.cn 

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:

福建省厦门市厦门大学翔安校区医学院成义楼402  

研究负责人通讯地址:

福建省厦门市厦门大学翔安校区医学院成义楼402  

Applicant address:

4th Floor, Chengyi Bulding, Xiang-an campus of Xiamen University, South Xiang-an Road, Xiamen, Fujian, China 

Study leader's address:

4th Floor, Chengyi Bulding, Xiang-an campus of Xiamen University, South Xiang-an Road, Xiamen, Fujian, 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:

厦门大学眼科研究所 

Applicant's institution:

Eye Institute of Xiamen 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:

2015006 

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:

厦门大学眼科研究所医学伦理委员会 

Name of the ethic committee:

Xiamen university institute of ophthalmology medical ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-12-16 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

厦门大学眼科研究所 

Primary sponsor:

Eye Institute of Xiamen University  

研究实施负责(组长)单位地址:

福建省厦门市厦门大学翔安校区医学院成义楼402  

Primary sponsor's address:

4th Floor, Chengyi Bulding, Xiang-an campus of Xiamen University, South Xiang-an Road, Xiamen, Fujian, 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):

福建省

市(区县):

厦门市

Country:

China

Province:

Fujian

City:

Xiamen

单位(医院):

厦门大学眼科研究所

具体地址:

福建省厦门市翔安南路厦门大学翔安校区医学院成义楼402

Institution
hospital:

Eye Institute of Xiamen University

Address:

4th Floor, Chengyi Bulding, Xiang-an campus of Xiamen University, South Xiang-an Road, Xiamen, Fujian, China

经费或物资来源:

日本千寿制药株式会社 

Source(s) of funding:

Senju Pharmaceutical Co., Ltd.  

研究疾病:

干燥综合征 

Target disease:

Sjogren's syndrome 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

IV期临床试验 

Study phase:

研究目的:

通过临床实验评价0.1%他克莫司(FK506)治疗干燥综合征眼征疗效 

Objectives of Study:

Through the clinical experiment evaluation 0.1% tacrolimus (FK506) eye dryness syndrome curative effect 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

入选标准: (1)自愿参加本项临床研究,并签署知情同意书。(2)性别不限,年龄18~70周岁。 (3)原发性干燥综合征患者风湿免疫科临床诊断明确,或伴有系统系红斑狼疮、风湿性关节炎合并眼部不适诊断为继发性干燥综合征患者。(4)眼征符合3项中一项或一项以上:每日感到不能忍受的眼干3月或3月以上;有反复沙子进眼或砂磨的感觉;需要人工泪液3次或3次以上。(5)研究眼别的选择:患者双均接受检查,以症状体征评分高的患眼为研究眼;如积分相等,取角膜荧光素染色较重的患眼为研究眼,如双眼荧光素染色程度相等则取右眼为研究眼。(6)试验2星期内未参加过其它药物临床试验。 

Inclusion criteria

Inclusion criteria: (1) participation in the clinical research, voluntary and sign a consent form; (2) Unlimited gender, aged 18 to 70 years; (3) of primary sjogren's syndrome in patients with clinical diagnosis of li rheumatism lead of the clear, or system is lupus erythematosus, rheumatoid arthritis, combined with discomfort diagnosed as secondary sjogren's syndrome patients. (4) eyes) in line with the three one or more than one: daily feel unbearable dry eye 3 months or more than 3 months;Have the feeling of sand into eyes or sanding repeatedly;Need artificial tears three times or more than 3 times; (5) the study choice: patients' eyes are checked, for the signs and symptoms score high risk of eye eye; Such as integral equal, corneal fluorescein staining for the study of the heavier with eye, such as eyes fluorescein staining degree equal to take the right eye eye for research; (6) test in 2 weeks did not attend any other drug clinica. 

排除标准:

排除标准: 凡有下列情况之一者,不作为入选病例: (1) 对试验药物中任何成分过敏者。 (2) 孕妇或哺乳期女性或近期有生育计划者。 (3) 临床上拟诊为真菌、细菌角、结膜炎活动期患者。 (4) 合并有其他结膜、角膜和虹膜明显病变者。 (5) 合并有严重心、脑血管、肝、肾及造血系统等严重原发病。 (6) 近六个月内有内眼手术或眼部外伤者。 (7) 绝经妇女激素替代治疗。 (8) 近1月内接受泪小点栓塞治疗。 (9) 青光眼或出现过眼压高的患者。 (10) 可能影响结果的治疗(如全身类同醇激素、免疫抑制治疗)。 (11) 试验期间无法停戴角膜接触镜者。 (12) 全身或眼部长期用药可能影响研究评估患者。 (14)在试验期间无法保证按要求用药及随访者。 

Exclusion criteria:

Exclusion criteria: Every one of the following circumstances, not as the case: (1) the test allergy to any ingredient in the drug; (2) pregnant or lactating women or recently have fertility planners; (3) the clinical examination for fungi, bacteria, Angle, conjunctivitis in active patients; (4) with other conjunctiva, cornea and iris obvious pathological changes; (5) with serious heart, cerebrovascular, liver, kidney and hematopoietic system, severe primary disease; (6) nearly six months have eye surgery within or outside of the injured eye; (7) postmenopausal hormone replacement therapy; (8) lacrimal point embolism therapy nearly 1 month; (9) high intraocular pressure of patients with glaucoma or seen; (10) may affect the outcome of treatment, such as systemic steroid hormones and immunosuppressive therapy); (11) experiments cannot stop wearing corneal contact lens; (12) patients with systemic or ocular long-term drug use may affect the research assessment; (13) during the test is no guarantee that drugs according to the requirements and with the visitor. 

研究实施时间:

Study execute time:

From2016-01-18To 2016-05-18 

征募观察对象时间:

Recruiting time:

From2016-01-18To 2016-05-18 

干预措施:

Interventions:

组别:

他克莫司组治疗组

样本量:

30

Group:

Tacrolimus therapy group

Sample size:

干预措施:

0.1%FK506+0.1%玻璃酸钠滴眼 一天两次 30天

干预措施代码:

Intervention:

0.1% FK506 + 0.1% sodium hyaluronate eye drops Twice a day for 30 days

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

福建 

市(区县):

厦门 

Country:

China 

Province:

Fujian 

City:

Xiamen 

单位(医院):

厦门大学附属厦门眼科中心 

单位级别:

三级甲等 

Institution
hospital:

Xiamen University affiliated Xiamen Eye Center  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

干眼问卷

指标类型:

主要指标 

Outcome:

dry eye questionnaire

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视力

指标类型:

主要指标 

Outcome:

vision

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

结膜水肿

指标类型:

主要指标 

Outcome:

conjunctival chemosis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

结膜充血

指标类型:

主要指标 

Outcome:

conjunctival congestion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睑缘改变

指标类型:

主要指标 

Outcome:

eyelid edge change

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睑板腺分泌能力

指标类型:

主要指标 

Outcome:

Meibomian gland secretion capacity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睑板腺分泌物性质

指标类型:

主要指标 

Outcome:

The nature of the meibomian gland secretion

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角膜混浊

指标类型:

主要指标 

Outcome:

corneal opacity

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角膜新生血管

指标类型:

主要指标 

Outcome:

corneal neovascularization

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角膜水肿

指标类型:

主要指标 

Outcome:

corneal edema

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

泪河高度

指标类型:

主要指标 

Outcome:

tear meniscus height

Type:

Primary 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:

主要指标 

Outcome:

TBUT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

泪液分泌实验

指标类型:

主要指标 

Outcome:

schirmer I test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

角膜共聚焦显微镜

指标类型:

主要指标 

Outcome:

confocal microscope

Type:

Primary 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:

标本中文名:

印迹细胞

组织:

结膜组织

Sample Name:

impression cytology

Tissue:

conjuncitva tissue

人体标本去向

使用后销毁 

说明

使用后销毁

Fate of sample:

Destruction after use 

Note:

Use after destruction

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 70 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):

符合入选标准的患者直接用药,定时复查

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

Meet the criteria for the patients with medication directly, regular review

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

否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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-12-30
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