ChiCTR2000031929 版本V1.0 版本创建时间2020/04/15 18:52:02 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：

 ChiCTR2000031929 

最近更新日期：

Date of Last Refreshed on：

 2020-04-15 04:39:25 

注册时间：

Date of Registration：

 2020-04-14 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Can dermatological tarcolimus 0.1 % ointment be used for treatment of spring catarrh? what is its efficacy and safety profile?

Public title：

Can dermatological tarcolimus 0.1 % ointment be used for treatment of spring catarrh? what is its efficacy and safety profile?

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Comparison of efficacy of dermatological 0.1% tacrolimus in treatment on vernal keratoconjunctivitis

Scientific title：

Comparison of efficacy of dermatological 0.1% tacrolimus in treatment on vernal keratoconjunctivitis

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：

Usama Iqbal 

研究负责人：

Usama Iqbal 

Applicant：

Usama Iqbal 

Study leader：

Usama Iqbal 

申请注册联系人电话：

Applicant telephone：

 +92 33 38255055

研究负责人电话：

Study leader's
telephone：

+92 33 38255055

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：

 usamaiqqbal@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 usamaiqqbal@gmail.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：

House 32, Street 8, Kabul Block, DC- Colony, Gujranwala, Punjab, Pakistan

研究负责人通讯地址：

House 32, Street 8, Kabul Block, DC- Colony, Gujranwala, Punjab, Pakistan

Applicant address：

House 32, Street 8, Kabul Block, DC- Colony, Gujranwala, Punjab, Pakistan

Study leader's address：

House 32, Street 8, Kabul Block, DC- Colony, Gujranwala, Punjab, Pakistan

申请注册联系人邮政编码：

Applicant postcode：

 52250

研究负责人邮政编码：

Study leader's postcode：

 52250

申请人所在单位：

巴基斯坦古吉兰瓦拉医学院

Applicant's institution：

Gujranwala Medical College

研究负责人所在单位：

巴基斯坦古吉兰瓦拉医学院

Affiliation of the Leader：

Gujranwala Medical College

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：

 182

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：

Institutional Review Board, Gujranwala Medical College/ Teaching Hospital, Gujranwala, Punjab, Pakistan

Name of the ethic committee：

Institutional Review Board, Gujranwala Medical College/ Teaching Hospital, Gujranwala, Punjab, Pakistan

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-07-06 00:00:00

伦理委员会联系人：

Institutional Review Board, Gujranwala Medical College

Contact Name of the ethic committee：

Institutional Review Board, Gujranwala Medical College

伦理委员会联系地址：

Gujranwala Medical College, Alipur Chatha Road, Gondlan Wala, Gujranwala, Punjab, Pakistan

Contact Address of the ethic committee：

Gujranwala Medical College, Alipur Chatha Road, Gondlan Wala, Gujranwala, Punjab, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +92 5 59230179

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：

Self-sponsored

Primary sponsor：

Self-sponsored

研究实施负责（组长）单位地址：

House 32, Street 8, Kabul Block, DC- Colony, Gujranwala, Punjab, Pakistan

Primary sponsor's address：

House 32, Street 8, Kabul Block, DC- Colony, Gujranwala, Punjab, Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

巴基斯坦

省(直辖市)：

旁遮普

市(区县)：

古吉兰瓦拉

Country：

Pakistan

Province：

Punjab

City：

Gujranwala

单位(医院)：

Gujranwala Medical college

具体地址：

Alipur Chatha Rd, Gondlan Wala, Gujranwala, Punjab

Institution
hospital：

Gujranwala Medical college

Address：

Alipur Chatha Rd, Gondlan Wala, Gujranwala, Punjab

经费或物资来源：

No funding

Source(s) of funding：

no funding

研究疾病：

春季角膜结膜炎  

Target disease：

vernal keratoconjunctivitis

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：

4

研究设计：

单臂 

Study design：

Single arm 

研究目的：

Tacrolimus has been used in different concentrations for ophthalmic use. It is used in 0.1 % as well as in 0.03% concentrations. Some studies claim it is more effective in 0.1 % concentration. In most studies tacrolimus is studied in bid dose, we intend to check its efficacy in HS dose.  

Objectives of Study：

Tacrolimus has been used in different concentrations for ophthalmic use. It is used in 0.1 % as well as in 0.03% concentrations. Some studies claim it is more effective in 0.1 % concentration. In most studies tacrolimus is studied in bid dose, we intend to check its efficacy in HS dose.

药物成份或治疗方案详述：

Study participants terminate all previous topical medications (antihistamine, mast cell stabilizers, NSAIDS, steroids), 1 week before starting treatment. patients applied small amount of tacrolimus 0.1% ointment to the inferior conjunctival fornix. the strategy was continued for one month. after that application of tacrolimus was taperred gradually over next 2 months. 

Description for medicine or protocol of treatment in detail：

Study participants terminate all previous topical medications (antihistamine, mast cell stabilizers, NSAIDS, steroids), 1 week before starting treatment. patients applied small amount of tacrolimus 0.1% ointment to the inferior conjunctival fornix. the strategy was continued for one month. after that application of tacrolimus was taperred gradually over next 2 months. 

纳入标准：

Inclusion criteria were all the pediatric patients of severe VKC, unmanageable with conventional treatment (anti-histamines/mast cell stabilizers/NSAIDS/steroids) or patients showing recurrence after discontinuation of steroids or having steroid-induced complications.

Inclusion criteria

Inclusion criteria were all the pediatric patients of severe VKC, unmanageable with conventional treatment (anti-histamines/mast cell stabilizers/NSAIDS/steroids) or patients showing recurrence after discontinuation of steroids or having steroid-induced complications.

排除标准：

Exclusion criteria were any coexisting ocular disorders such as conjunctival or corneal diseases, ocular infections, uveitis, Stevens Johnson syndrome, contact lens usage, history of ocular surgery. Informed consent was taken and all the patients were explained about the study.

Exclusion criteria：

Exclusion criteria were any coexisting ocular disorders such as conjunctival or corneal diseases, ocular infections, uveitis, Stevens Johnson syndrome, contact lens usage, history of ocular surgery. Informed consent was taken and all the patients were explained about the study.

研究实施时间：

Study execute time：

从 From 2019-07-01 00:00:00至 To 2020-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-07-01 00:00:00 至 To 2019-12-31 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 50

Group：

Case series

Sample size：

干预措施：

topical application of tacrolimus in conjunctival fornix at night

干预措施代码：

Intervention：

tacrolimus topical

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 旁遮普 

市(区县)：

 古吉兰瓦拉 

Country：

Pakistan

Province：

Punjab

City：

Gujranwala

单位(医院)：

 DHQ Hospital Gujranwala 

单位级别：

 三级医院 

Institution
hospital：

DHQ Hospital Gujranwala

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

Symptoms

指标类型：

主要指标

Outcome：

Symptoms

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Conjunctival Hyperemia

指标类型：

主要指标

Outcome：

Conjunctival Hyperemia

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Papillae size

指标类型：

主要指标

Outcome：

Papillae size

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Tranta dots

指标类型：

主要指标

Outcome：

Tranta dots

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

SPK grade

指标类型：

主要指标

Outcome：

SPK grade

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：

无

组织：

Sample Name：

No sample taken

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 7 岁 years
最大 Max age 14 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）：

N/A

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

N/A

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：

N/A

Blinding：

N/A

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）：

Not stated

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

Not stated

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：

Evaluation of symptoms of VKC was done on clinical basis and severity was classified as 0(none), 1 (mild), 2 (moderate), 3 (severe) (Table 1). Similarly, clinical signs were also categorized by one observer into scale 0 (none), scale 1 (mild), scale 2 (moderate), or scale 3 (severe) .At each follow-up visits , change in clinical signs and symptoms were studied to obtain the final clinical score along with photographs. To check the safety and adverse effects of treatment intraocular pressure, lens opacifications, secondary infections and other possible complications were also evaluated. Improvement of each symptom or sign was defined as at least 1-score reduction in severity compared with values before the treatment. Paired t-test was used to statistically analyze the changes in mean clinical score before and after treatment. Data was analyzed using SPSS version 23.0. Results were expressed as Mean±SD and percentages. P ≤ 0.05 was considered as statistically significant.

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

Evaluation of symptoms of VKC was done on clinical basis and severity was classified as 0(none), 1 (mild), 2 (moderate), 3 (severe) (Table 1). Similarly, clinical signs were also categorized by one observer into scale 0 (none), scale 1 (mild), scale 2 (moderate), or scale 3 (severe) .At each follow-up visits , change in clinical signs and symptoms were studied to obtain the final clinical score along with photographs. To check the safety and adverse effects of treatment intraocular pressure, lens opacifications, secondary infections and other possible complications were also evaluated. Improvement of each symptom or sign was defined as at least 1-score reduction in severity compared with values before the treatment. Paired t-test was used to statistically analyze the changes in mean clinical score before and after treatment. Data was analyzed using SPSS version 23.0. Results were expressed as Mean±SD and percentages. P ≤ 0.05 was considered as statistically significant.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2020-04-15 04:39:25