Eye Dryness Evaluation in Primary Sjögren's Syndrome

Completed

• Conditions: Primary Sjögren Syndrome
• Interventions: Other: Ecological symptom measurements using a webapp; Diagnostic Test: Interferometry

• Registration Number: NCT03614299
• Lead Sponsor: University Hospital, Brest

Brief 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.

Study Timeline

• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-03
• Study Start: 2019-11-20
• Primary Completion: 2020-08-28
• Study Completion: 2020-08-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• diagnosis of pSS according to ACR/EULAR classification criteria

Exclusion Criteria

• patient does not possess a smartphone with web connection
• patient unable to sign an informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pSS cohort	Interferometry	Patients with pSS included in the study
pSS cohort	Ecological symptom measurements using a webapp	Patients with pSS included in the study

Primary Outcome Measures

Name	Time	Method
Variability in the intensity of patient-reported symptoms	3 months	Variability over time (day-to-day assessment) of the ESSPRI score (dispersion of the values compared to the mean)

Secondary Outcome Measures

Name	Time	Method
Interferometry	3 months	Measure of mebomian function using the LipiView technology
Tolerability of the daily use of a webapp to measure the symptoms	Month 3	Score Questionnaire SUS - System Usability Scale. The SUS ranges from 0 to 100, with values above 68 considered as above average.
Automated eye surface coloration measurement	3 months	Development of an automated method using deep image mining on recorded videos

Trial Locations

Locations (1)

CHU de BREST; 🇫🇷 Brest, France