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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 11 December 2017
Main ID:  ChiCTR-IPR-17013772
Date of registration: 2017-12-08
Prospective Registration: Yes
Primary sponsor: The Eye Hospital of Wenzhou Medical University
Public title: A Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry Eye
Scientific title: A Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry Eye
Date of first enrolment: 2018-01-01
Target sample size: group of tacrolimus eye drops:30;group of flurometholone eye drops:30;
Recruitment status: Pending
URL:  http://www.chictr.org.cn/showproj.aspx?proj=23696
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  Post-market
Countries of recruitment
China
Contacts
Name: Wei Chen   
Address:  270 Xueyuan Road West, Wenzhou, Zhejiang, China
Telephone: +86 13757728118
Email: chenweimd@hotmail.com
Affiliation:  The Eye Hospital of Wenzhou Medical University
Name: Wei Lin   
Address:  270 Xueyuan Road West, Wenzhou, Zhejiang, China
Telephone: +86 13587560390
Email: linweiysg@163.com
Affiliation:  The Eye Hospital of Wenzhou Medical University
Key inclusion & exclusion criteria
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.

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.


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Sjogren's Syndrome Dry Eye
Intervention(s)
group of tacrolimus eye drops:tacrolimus eye drops;group of flurometholone eye drops:flurometholone eye drops;
Primary Outcome(s)
eye dryness score (EDS);
Secondary Outcome(s)
Ocular Surface Disease Index (OSDI);BUT;corneal fluorescein staining;Schirmer I test;intraocular pressure (IOP);
Secondary ID(s)
Source(s) of Monetary Support
Supporting funds of the National Natural Science Foundation of China
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 07/12/2017
Contact:
Chenxiao Wang
Results
Results available:
Date Posted:
Date Completed:
URL:
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