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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03614299
Other study ID # 29BRC18.0173
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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