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

• 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
• URL: http://www.chictr.org.cn/showproj.aspx?proj=12965
• Study type: Observational study
• Study design: historical control
• Phase: IV (Phase IV study)

Countries of recruitment

China

Contacts

• Name: Shu Yang
• Affiliation: Eye Institute of Xiamen University

• Name: Zuguo Liu

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

Intervention(s)

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;

Source(s) of Monetary Support

Senju Pharmaceutical Co., Ltd.