Eye Dryness Evaluation in Primary Sjögren's Syndrome

NCT03614299 | Completed

• 1 other identifier: 29BRC18.0173
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sjögren Syndrome

Outcome Measures

Primary Outcomes (1)

• Variability in the intensity of patient-reported symptoms

  Variability over time (day-to-day assessment) of the ESSPRI score (dispersion of the values compared to the mean)

  3 months

Secondary Outcomes (3)

• Tolerability of the daily use of a webapp to measure the symptoms

  Month 3

• Interferometry

  3 months

• Automated eye surface coloration measurement

  3 months

Study Arms (1)

pSS cohort

Patients with pSS included in the study

Other: Ecological symptom measurements using a webapp; Diagnostic Test: Interferometry

Interventions

Ecological symptom measurements using a webapp OTHER

A webapp will be installed on the patients' smartphone, which will be used to collect everyday the symptoms of the patients (ESSPRI score)

pSS cohort

Interferometry DIAGNOSTIC_TEST

Evaluation of the mebomian function using the LipiView methodology

pSS cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive pSS patients seen in Rheumatology

You may qualify if:

• diagnosis of pSS according to ACR/EULAR classification criteria

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU de BREST

Brest, 29200, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, saliva, cells

MeSH Terms

Interventions

Microscopy, Interference

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Interferometry; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 3, 2018
• Study Start: November 20, 2019
• Primary Completion: August 28, 2020
• Study Completion: August 28, 2020
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning after publication of result and ending three years maximum following the last visit of last patient
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)