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

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

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIB-16007789
Enrollment
Unknown
Registered
2015-12-30
Start date
2016-01-18
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren's syndrome

Interventions

Sponsors

Eye Institute of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion 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: 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.

Design outcomes

Primary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactZuguo Liu
zuguoliu@xmu.edu.cn+86 18959289999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026