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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: 18 April 2017
Main ID:  ChiCTR-OIB-16007789
Date of registration: 2015-12-30
Prospective Registration: Yes
Primary sponsor: Eye Institute of Xiamen University
Public title: 0.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation
Scientific title: 0.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation
Date of first enrolment: 2016-01-18
Target sample size: Tacrolimus therapy group:30;
Recruitment status: Recruiting
Study type:  Observational study
Study design:  historical control  
Phase:  IV (Phase IV study)
Countries of recruitment
Name: Zuguo Liu   
Address:  4th Floor, Chengyi Bulding, Xiang-an campus of Xiamen University, South Xiang-an Road, Xiamen, Fujian, China
Telephone: +86 18959289999
Name: Shu Yang   
Address:  4th Floor, Chengyi Bulding, Xiang-an campus of Xiamen University, South Xiang-an Road, Xiamen, Fujian, China
Telephone: +86 13606935286
Affiliation:  Eye Institute of Xiamen University
Key inclusion & exclusion criteria
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.

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.

Age minimum: 18
Age maximum: 70
Gender: Both
Health Condition(s) or Problem(s) studied
Sjogren's syndrome
Tacrolimus therapy group:0.1% FK506 + 0.1% sodium hyaluronate eye drops Twice a day for 30 days;
Primary Outcome(s)
dry eye questionnaire;vision;conjunctival chemosis;conjunctival congestion;eyelid edge change;Meibomian gland secretion capacity;The nature of the meibomian gland secretion;corneal opacity;corneal neovascularization;corneal edema;tear meniscus height;TBUT;schirmer I test;confocal microscope;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Senju Pharmaceutical Co., Ltd.
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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