Eye Dryness Evaluation in Primary Sjögren's Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Primary Sjögren Syndrome

Intervention / Treatment
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* Other: Ecological symptom measurements using a webapp
* Diagnostic Test: Interferometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pSS cohort<br>Patients with pSS included in the study | Other: Ecological symptom measurements using a webapp<br>* A webapp will be installed on the patients' smartphone, which will be used to collect everyday the symptoms of the patients (ESSPRI score)<br>Diagnostic Test: Interferometry<br>* Evaluation of the mebomian function using the LipiView methodology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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