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阿奇黴素 (Azithromycin) 和多西環素 (Doxycycline) 治療瞼板腺功能失調
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注册号：

Registration number：

 ChiCTR-IPC-15006715 

最近更新日期：

Date of Last Refreshed on：

 2015-07-16 11:28:18 

注册时间：

Date of Registration：

 2015-07-09 11:54:49 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

阿奇黴素 (Azithromycin) 和多西環素 (Doxycycline) 治療瞼板腺功能失調

Public title：

Azithromycin and Doxycycline in the Management of Meibomian Gland Dysfunction

注册题目简写：

English Acronym：

MGD

研究课题的正式科学名称：

阿奇黴素 (Azithromycin) 和多西環素 (Doxycycline) 治療瞼板腺功能失調

Scientific title：

Azithromycin and Doxycycline in the Management of Meibomian Gland Dysfunction

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：

CUHK_CCT00463

申请注册联系人：

Miss Mak Hoi Ching Haley 

研究负责人：

Dr. Vanissa Wing-see CHOW 

Applicant：

Miss Mak Hoi Ching Haley 

Study leader：

Dr. Vanissa Wing-see CHOW 

申请注册联系人电话：

Applicant telephone：

 +852 39435833

研究负责人电话：

Study leader's
telephone：

+852 39435833

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：

 haleymak@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 vanissa.chow@gmail.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00463

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00463

申请注册联系人通讯地址：

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

研究负责人通讯地址：

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

Applicant address：

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

Study leader's address：

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

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：

Department of Ophthalmology and Visual Sciences, Chinese University of Hong Kong

Applicant's institution：

Department of Ophthalmology and Visual Sciences, Chinese University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

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：

 NA

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：

Chinese University of Hong Kong

Name of the ethic committee：

Chinese University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2015-06-10 00:00:00

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：

Hong Kong Medical Supplies Ltd (Thea Laboratories)

Primary sponsor：

Hong Kong Medical Supplies Ltd (Thea Laboratories)

研究实施负责（组长）单位地址：

Hong Kong Medical Supplies Ltd (Thea Laboratories)

Primary sponsor's address：

Hong Kong Medical Supplies Ltd (Thea Laboratories)

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Hong Kong Medical Supplies Ltd (Thea Laboratories)

Source(s) of funding：

Hong Kong Medical Supplies Ltd (Thea Laboratories)

研究疾病：

Azithromycin, doxycyline, MGD, blepharitis, dry eyes  

Target disease：

Azithromycin, doxycyline, MGD, blepharitis, dry eyes

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：

 I期临床试验 

Study phase：

1

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

阿奇黴素 (Azithromycin) 和多西環素 (Doxycycline) 治療瞼板腺功能失調  

Objectives of Study：

Azithromycin and Doxycycline in the Management of Meibomian Gland Dysfunction

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. On treatment for MGD or dry eye syndrome other than warm compresses, lid massage and lubricants in the past 3 months;
2. Schirmer's test without anaesthesia <5mm per 5 minutes in both eyes - Pretreatment LipiView score >=100 in both eyes;
3. Known allergy to tetracycline or macrolide;
4. Pregnant or breast feeding women;
5. Women planning pregnancy;
6. Hepatic impairment or on hepatotoxic drugs;
7. Severe renal impairment;
8. Ocular condition that causes similar symptoms and signs as MGD, including structural lid abnormalities, lagothalmos, conjunctivochalasis, contact lens wear, thyroid eye disease;
9. On systemic medications that may contribute to dry eye without being on a stable dose in the past 1 month.

Exclusion criteria：

1. On treatment for MGD or dry eye syndrome other than warm compresses, lid massage and lubricants in the past 3 months;
2. Schirmer's test without anaesthesia <5mm per 5 minutes in both eyes - Pretreatment LipiView score >=100 in both eyes;
3. Known allergy to tetracycline or macrolide;
4. Pregnant or breast feeding women;
5. Women planning pregnancy;
6. Hepatic impairment or on hepatotoxic drugs;
7. Severe renal impairment;
8. Ocular condition that causes similar symptoms and signs as MGD, including structural lid abnormalities, lagothalmos, conjunctivochalasis, contact lens wear, thyroid eye disease;
9. On systemic medications that may contribute to dry eye without being on a stable dose in the past 1 month.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-07-18 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 50

Group：

Two groups

Sample size：

干预措施：

Azithromycin 1.5% Topical; Doxycyline 100mg Oral; Multivitamin Daily 1 Plus 1 tablet Oral Three months

干预措施代码：

Intervention：

Azithromycin 1.5% Topical; Doxycyline 100mg Oral; Multivitamin Daily 1 Plus 1 tablet Oral Three months

Intervention code：

组别：

(to be continued)

样本量：

 50

Group：

(to be continued)

Sample size：

干预措施：

Group 1 (control treatment): topical azithromycin to both eyes, twice daily for 3 days, then once daily for 25 days; and oral multivitamin (Daily 1 Plus) 1 tablet a day concurrently for 28 days as placebo

干预措施代码：

Intervention：

Group 1 (control treatment): topical azithromycin to both eyes, twice daily for 3 days, then once daily for 25 days; and oral multivitamin (Daily 1 Plus) 1 tablet a day concurrently for 28 days as placebo

Intervention code：

组别：

(to be continued)

样本量：

 50

Group：

(to be continured)

Sample size：

干预措施：

Group 2 (study treatment): topical azithromycin as above, and oral doxycycline 100mg (1 tablet) a day concurrently for 28 days.

干预措施代码：

Intervention：

Group 2 (study treatment): topical azithromycin as above, and oral doxycycline 100mg (1 tablet) a day concurrently for 28 days.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Chinese University of Hong Kong 

单位级别：

 Chinese University of Hong Kong 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

Improvement in symptom frequency score based on self-administered OSDI questionnaire at month 1

指标类型：

主要指标

Outcome：

Improvement in symptom frequency score based on self-administered OSDI questionnaire at month 1

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Improvement in symptom frequency score based on self-administered OSDI questionnaire at month 3

指标类型：

次要指标

Outcome：

Improvement in symptom frequency score based on self-administered OSDI questionnaire at month 3

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Improvement in symptom severity score based on self-administered SPEED questionnaire

指标类型：

次要指标

Outcome：

Improvement in symptom severity score based on self-administered SPEED questionnaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Clinical grading of MGD based on conjunctival injection, lid margin redness, ocular surface staining, meibomian gland expressability, number of glands plugged and quality of meibum13

指标类型：

次要指标

Outcome：

Clinical grading of MGD based on conjunctival injection, lid margin redness, ocular surface staining, meibomian gland expressability, number of glands plugged and quality of meibum13

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Best- corrected visual acuity

指标类型：

次要指标

Outcome：

Best- corrected visual acuity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Lipid layer thickness measurement by LipiView interferometer (TearScience Inc., Morrisville, NC, USA) The LipiView interferometer (TearScience Inc., Morrisville, NC, USA) measures interferometric color units (ICU), where 1 ICU approximately reflects 1 nm of the lipid layer thickness.

指标类型：

次要指标

Outcome：

Lipid layer thickness measurement by LipiView interferometer (TearScience Inc., Morrisville, NC, USA) The LipiView interferometer (TearScience Inc., Morrisville, NC, USA) measures interferometric color units (ICU), where 1 ICU approximately reflects 1 nm of the lipid layer thickness.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

18 A LipiView image of the tear film can be captured during a non-invasive in-office exam that takes about 5 minutes.

指标类型：

次要指标

Outcome：

18 A LipiView image of the tear film can be captured during a non-invasive in-office exam that takes about 5 minutes.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

The tear film can be seen as an array of colors called specular observations that are relected when the subject rest his head on the chin-rest and a controlled light source is directed towards the front surface of the eye.

指标类型：

次要指标

Outcome：

The tear film can be seen as an array of colors called specular observations that are relected when the subject rest his head on the chin-rest and a controlled light source is directed towards the front surface of the eye.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Non-invasive tear break-up time, infrared meibography, tear film assessment and R-scan (bulbar conjunctival redness evaluation) with OCULUS Keratograph 5M (Oculus, Wetzlar, Germany) OCULUS Keratograph 5M (Oculus, Wetzlar, Germany) uses white or infrared illumination to assess the tear film and tear break-up time

指标类型：

次要指标

Outcome：

Non-invasive tear break-up time, infrared meibography, tear film assessment and R-scan (bulbar conjunctival redness evaluation) with OCULUS Keratograph 5M (Oculus, Wetzlar, Germany) OCULUS Keratograph 5M (Oculus, Wetzlar, Germany) uses white or infrared illumination to assess the tear film and tear break-up time

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

infrared camera for meibomian gland imaging; and color camera for conjunctival blood vessel imaging.

指标类型：

次要指标

Outcome：

infrared camera for meibomian gland imaging; and color camera for conjunctival blood vessel imaging.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

All measurements will be non-invasive. Subjects will be instructed to rest his head on the chin- rest during imaging, which takes about 5 minutes.

指标类型：

次要指标

Outcome：

All measurements will be non-invasive. Subjects will be instructed to rest his head on the chin- rest during imaging, which takes about 5 minutes.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Tear analysis (10 patients in each arm): osmolarity, cytokines, matrix metalloproteinases

指标类型：

次要指标

Outcome：

Tear analysis (10 patients in each arm): osmolarity, cytokines, matrix metalloproteinases

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Side effects noted during treatment

指标类型：

次要指标

Outcome：

Side effects noted during treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Compliance to treatment

指标类型：

次要指标

Outcome：

Compliance to treatment

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 12 岁 years
最大 Max age 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

Randomized

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

Randomized

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Double-blind

Blinding：

Double-blind

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

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：

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2015-07-16 11:28:18
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