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Eye Dryness Evaluation in Primary Sjögren's Syndrome — PEPSS  

Primary Sjögren Syndrome Clinical Trial

Official title:
Pateint-reported Outcomes and Objective Eye Dryness Evaluation in Primary Sjögren's Syndrome.

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03614299
Study type Observational
Source University Hospital, Brest
Contact
Status Not yet recruiting
Phase
Start date October 1, 2019
Completion date December 1, 2020
View Details
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