Eye Dryness Evaluation in Primary Sjögren's Syndrome

Primary Sjögren Syndrome Clinical Trial

— PEPSS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03614299
• Other study ID #: 29BRC18.0173
• Status: Not yet recruiting
• Start date: October 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Primary Sjögren Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Interferometry	Measure of mebomian function using the LipiView technology	3 months
Secondary	Automated eye surface coloration measurement	Development of an automated method using deep image mining on recorded videos	3 months