Eye Dryness Evaluation in Primary Sjögren's Syndrome (PEPSS)

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Primary Sjögren Syndrome

Treatments

Diagnostic Test: Interferometry

Other: Ecological symptom measurements using a webapp

Study type

Observational

Funder types

Other

Identifiers

NCT03614299

29BRC18.0173

Details and patient eligibility

About

The objective of this observational study is to develop new tools to assess primary Sjögren's syndrome (pSS) symptoms and to measure the severity of eye involvement in these patients.

Full description

All clinical trials evaluating the efficacy of immunomodulatory drugs in pSS are negative. This could be due to a lack of sensitivity of the outcome measures used so far to define the response. In this study, investigator will evaluate the feasability, tolerability, and performance of new tools to assess disease evolution:

investigator will develop a webapp to measure the intensity of the symptoms at home on a daily basis (ecological assessment)
investigator will evaluate new ophthalmologic procedures, already used in other conditions but never in pSS, which assess the severity of eye involvement in the disease
investigator will develop an automated method to score the severity of ocular surface lesions in the disease.

Patients with a diagnosis of pSS will be included in the study, will undergo detailed ophtalmologic examination, and will then use a webapp, installed on their smartphone, to score their symptoms everyday during 3 months.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria