Primary Sjögren SyndromePEPSSNCT03614299
Eye Dryness Evaluation in Primary Sjögren's Syndrome
An observational study of Primary Sjögren Syndrome, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sjögren Syndrome
- What is being tested?
- Ecological symptom measurements using a webapp and Interferometry
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2019to 28 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive pSS patients seen in Rheumatology
Who may be able to join
- diagnosis of pSS according to ACR/EULAR classification criteria
Who cannot join
- patient does not possess a smartphone with web connection
- patient unable to sign an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pateint-reported Outcomes and Objective 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.
Read the detailed 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.
- Conditions
- Primary Sjögren Syndrome
- Being tested
- Ecological symptom measurements using a webapp, Interferometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological symptom measurements using a webappOther
A webapp will be installed on the patients' smartphone, which will be used to collect everyday the symptoms of the patients (ESSPRI score)
InterferometryDiagnostic test
Evaluation of the mebomian function using the LipiView methodology
| Study group | Role | What they receive |
|---|---|---|
| pSS cohort | Patients with pSS included in the study Receives: Other: Ecological symptom measurements using a webapp; Diagnostic Test: Interferometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (3)
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.
Measured: Month 3
Interferometry
Measure of mebomian function using the LipiView technology
Measured: 3 months
Automated eye surface coloration measurement
Development of an automated method using deep image mining on recorded videos
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start20 Nov 2019
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614299
- Sponsor's protocol ID
- 29BRC18.0173
- Acronym
- PEPSS
- Status last verified
- Feb 2025
- First submitted
- 31 Jul 2018
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pateint-reported Outcomes and Objective Eye Dryness Evaluation in Primary Sjögren's Syndrome.
- ClinicalTrials.gov ID
- NCT03614299
- Acronym / sponsor ID
- PEPSS / 29BRC18.0173
- Conditions
- Primary Sjögren Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pSS cohort | – | Other: Ecological symptom measurements using a webapp, Diagnostic Test: InterferometryPatients with pSS included in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive pSS patients seen in Rheumatology
Key inclusion criteria (1 listed)
- diagnosis of pSS according to ACR/EULAR classification criteria
Key exclusion criteria (2 listed)
- patient does not possess a smartphone with web connection
- patient unable to sign an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological symptom measurements using a webappA webapp will be installed on the patients' smartphone, which will be used to collect everyday the symptoms of the patients (ESSPRI score) | Other | pSS cohort |
| InterferometryEvaluation of the mebomian function using the LipiView methodology | Diagnostic test | pSS cohort |
Primary outcome
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)
3 secondary outcomes
Tolerability of the daily use of a webapp to measure the symptoms
Time frame: Month 3
Interferometry
Time frame: 3 months
Automated eye surface coloration measurement
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Sjögren Syndrome, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability in the intensity of patient-reported symptoms (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.