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Immunologic profile of tears and conjunctiva in Sjögren*s syndrome

Immunologic profile of tears and conjunctiva in Sjögren*s syndrome - SIMPLE

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38566
Enrollment
87
Registered
2013-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Sjogren syndrome

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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 BUT18 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The main study endpoint is to assess biomarkers, including anti-Ro/SSA, anti-La/SSB, BAFF, APRIL and chemokine CXCL10, in the tears of patients with primary Sjögren*s syndrome compared to that of other subjects of non Sjögren*s syndrome dry eye patients and healthy subjects.

Secondary

MeasureTime frame
Secondary endpoints will be the assessment tear osmolarity in the tears of primary Sjögren*s syndrome patients in comparison to non Sjögren*s syndrome dry eye patients and healthy subjects. Furthermore, assessment of immunologic characteristics of conjunctival epithelial cells in patients with primary Sjögren*s syndrome in comparison to non Sjögren*s syndrome dry eye patients and healthy subjects.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)