Eye DiseasesESSONCT06255301
Collection of Ocular Surface Impressions Cytology of the Living Eye From Patients With Dry Eyes or Limbal Stem Cell Deficiency.
An observational study of Eye Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
In order to develop innovative biomarkers for the diagnosis of two ocular surface pathologies, Dry Syndrome (DS) and Limbic Stem Cell Deficiency (LSCD), human cells from the ocular surface will be collected in order to test these biomarkers ex vivo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Diseases
- What is being tested?
- EYEPRIM
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2024to 21 Mar 2024
- 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: * 50 patients with limbal stem cell deficiency * 100 patients with dry eye syndrome * 150 patients with eye diseases other than dry eye syndrome or limbal stem cell deficiency
Who may be able to join
- Patient affiliated or entitled to a social security scheme
- Age 18 years or older
- Presenting a Dry Syndrome, a limbic stem cell deficiency (clinical diagnosis) or another pathology (control).
- Signature of Consent
Who cannot join
- Major blepharospasm making examination impossible
- Pregnant women
- Breastfeeding women
- Protected Persons
Trial locations and contacts
1 site in 1 country.
About this study
In order to develop innovative biomarkers for the diagnosis of two ocular surface pathologies, Dry Syndrome (DS) and Limbic Stem Cell Deficiency (LSCD), human cells from the ocular surface will be collected in order to test these biomarkers ex vivo.
Read the detailed description
To collect them, cytological fingerprints of the ocular surface are made using filter paper applied to the surface using a commercially available EC (European Conformity)-marked medical device, called EYEPRIM.
- Conditions
- Eye Diseases
- Being tested
- EYEPRIM
- Keywords
- biomarkers, limbic stem cell deficiency, dry syndrome, EYEPRIM
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYEPRIMDiagnostic test
Collection of conjunctival impressions using the EC(European Conformity )-marked EYEPRIM device . This device enables cells to be collected the superficial ocular surface cells by applying a membrane for few seconds to the ocular surface.
| Study group | Role | What they receive |
|---|---|---|
| Control group | 150 patients with eye diseases other than dry eye syndrome or limbal stem cell deficiency will be included. Receives: Diagnostic Test: EYEPRIM | |
| dry eye syndrome | 100 patients with dry eye syndrome will be included. Receives: Diagnostic Test: EYEPRIM | |
| limbal stem cell deficiency | 50 patients with limbal stem cell deficiency will be included. Receives: Diagnostic Test: EYEPRIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface impression cytology collected from patients suffering from dry eye syndrome, limbal stem cell deficiency or other pathologies (control).
Collection of cells from the ocular surface by performing a cytological imprint of the ocular surface
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start9 Jan 2024
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Biologie, Ingénierie et Imagerie de la Greffe de Cornée (BiiGC)
- Responsible party
- Sponsor
- Investigators
- Gilles THURET, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255301
- Sponsor's protocol ID
- 19CH218
- Other IDs
- 2020-A00139-30
- Acronym
- ESSO
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Ocular Surface Impressions Cytology of the Living Eye From Patients With Dry Eyes or Limbal Stem Cell Deficiency.
- ClinicalTrials.gov ID
- NCT06255301
- Acronym / sponsor ID
- ESSO / 19CH218
- Conditions
- Eye Diseases
- Keywords
- biomarkers, limbic stem cell deficiency, dry syndrome, EYEPRIM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Laboratoire Biologie, Ingénierie et Imagerie de la Greffe de Cornée (BiiGC)
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 13 Feb 2024 (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.
In order to develop innovative biomarkers for the diagnosis of two ocular surface pathologies, Dry Syndrome (DS) and Limbic Stem Cell Deficiency (LSCD), human cells from the ocular surface will be collected in order to test these biomarkers ex vivo.
Detailed description
To collect them, cytological fingerprints of the ocular surface are made using filter paper applied to the surface using a commercially available EC (European Conformity)-marked medical device, called EYEPRIM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: EYEPRIM150 patients with eye diseases other than dry eye syndrome or limbal stem cell deficiency will be included. |
| dry eye syndrome | – | Diagnostic Test: EYEPRIM100 patients with dry eye syndrome will be included. |
| limbal stem cell deficiency | – | Diagnostic Test: EYEPRIM50 patients with limbal stem cell deficiency will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * 50 patients with limbal stem cell deficiency * 100 patients with dry eye syndrome * 150 patients with eye diseases other than dry eye syndrome or limbal stem cell deficiency
Key inclusion criteria (4 listed)
- Patient affiliated or entitled to a social security scheme
- Age 18 years or older
- Presenting a Dry Syndrome, a limbic stem cell deficiency (clinical diagnosis) or another pathology (control).
- Signature of Consent
Key exclusion criteria (4 listed)
- Major blepharospasm making examination impossible
- Pregnant women
- Breastfeeding women
- Protected Persons
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 |
|---|---|---|
| EYEPRIMCollection of conjunctival impressions using the EC(European Conformity )-marked EYEPRIM device . This device enables cells to be collected the superficial ocular surface cells by applying a membrane for few seconds to the ocular surface. | Diagnostic test | Control group, dry eye syndrome, limbal stem cell deficiency |
Primary outcome
Ocular surface impression cytology collected from patients suffering from dry eye syndrome, limbal stem cell deficiency or other pathologies (control).
Time frame: day one
Collection of cells from the ocular surface by performing a cytological imprint of the ocular surface
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 24 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Gilles THURET, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Eye Diseases, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 4 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 24 Apr 2024. 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?
Ocular surface impression cytology collected from patients suffering from dry eye syndrome, limbal stem cell deficiency or other pathologies (control). (time frame: day one). 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 24 Apr 2024.