NCT03614299

Eye Dryness Evaluation in Primary Sjögren's Syndrome

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Primary Sjögren Syndrome

Interventions

Type	Name	Description
OTHER	Ecological symptom measurements using a webapp	A webapp will be installed on the patients' smartphone, which will be used to collect everyday the symptoms of the patients (ESSPRI score)
DIAGNOSTIC_TEST	Interferometry	Evaluation of the mebomian function using the LipiView methodology

Timeline

• Start date: 2019-11-20
• Primary completion: 2020-08-28
• Completion: 2020-08-28
• First posted: 2018-08-03
• Last updated: 2025-02-05

Locations

1 site across 1 country: France