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Completed

NCT Number: NCT03614299

Eye Dryness Evaluation in Primary Sjögren's Syndrome

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.

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Key information

Conditions

Primary Sjögren Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de BREST

Brest, 29200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Interferometry

Diagnostic Test

Evaluation of the mebomian function using the LipiView methodology

Primary outcomes

  1. Variability in the intensity of patient-reported symptoms

    Time frame: 3 months

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

Secondary outcomes

  1. Tolerability of the daily use of a webapp to measure the symptoms

    Time frame: Month 3

    Score Questionnaire SUS - System Usability Scale. The SUS ranges from 0 to 100, with values above 68 considered as above average.

  2. Interferometry

    Time frame: 3 months

    Measure of mebomian function using the LipiView technology

  3. Automated eye surface coloration measurement

    Time frame: 3 months

    Development of an automated method using deep image mining on recorded videos

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: PEPSS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 3, 2018
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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