Immunologic profile of tears and conjunctiva in Sjögren*s syndrome
- Conditions
- Sjogren syndrome10030064
- Registration Number
- NL-OMON38566
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 87
Sjögren syndrome patients
- Primary Sjögren's syndrome diagnosed by our rheumatology departement,
- >18 years;Other dry eye patients:
- dry eye disease without Sjögren*s syndrome criteria (punctate keratitis or BUT<10sec)
- tear production should be normal over 10mm on Schirmer
- and staining with Lissamine green should be less than 5
- Age >18 years. ;Healthy subjects
- Age >18 years
- No dry eye complaints
- a tear production higher than 10mm on Schirmer
- Lissamine green staining score less than 5
Use of topical steroid eye drops, use of anti-glaucomatous eye drops, ocular surgery in the year before participation, chronic contact lens wear, history of ocular herpes keratitis. Use of immunomodulating drugs (prednison, cyclosporin);Healthy controls extra exclusion criteria will be a history of ocular disease or ocular complaints and use of artificial tears < 3 months of study.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoint is to assess biomarkers, including anti-Ro/SSA,<br /><br>anti-La/SSB, BAFF, APRIL and chemokine CXCL10, in the tears of patients with<br /><br>primary Sjögren*s syndrome compared to that of other subjects of non Sjögren*s<br /><br>syndrome dry eye patients and healthy subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints will be the assessment tear osmolarity in the tears of<br /><br>primary Sjögren*s syndrome patients in comparison to non Sjögren*s syndrome dry<br /><br>eye patients and healthy subjects. Furthermore, assessment of immunologic<br /><br>characteristics of conjunctival epithelial cells in patients with primary<br /><br>Sjögren*s syndrome in comparison to non Sjögren*s syndrome dry eye patients and<br /><br>healthy subjects.</p><br>