Dry Eye Syndrome (DES)Prot-CSANCT07632534
Study of Proteomic Factors in Patients With Severe Dry Eye Syndrome Treated With Autologous Serum Eye Drops.
A study testing Autologous serum eye drops and Collecting data from the medical record in people with Dry Eye Syndrome (DES) and Dry Eye, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Dry eye syndrome is a multifactorial pathology of the ocular surface. Epidemiological studies report a prevalence of 15% in adults aged between 50 and 95. Depending on the severity of the disease, different treatment strategies may be proposed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome (DES), Dry Eye
- What is being tested?
- Autologous serum eye drops and Collecting data from the medical record
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age over 18 years
- Patients with severe dry eye with an Oxford score > 1
- Patients with dry eye syndrome refractory to conventional treatments: tear substitutes, immunosuppressive eye drops or corticosteroids.
- AS-naïve patients followed by an ophthalmologist at Saint-Etienne University Hospital
- Patients affiliated to or entitled under a social security scheme
- Patients who have received informed information about the study
Who cannot join
- Severe ocular dryness due to a genetic disease
- Patients not under the care of an ophthalmologist at Saint-Etienne University Hospital.
- Patients not eligible for treatment with AS (pregnant women, anaemia, current infection, progressive disease, serological results contraindicating blood sampling).
- Patients under protective measures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
Elodie JACQUEROUX, MD
Freddy MOUNSEF, MD
About this study
Official title: Study of Proteomic Factors in Patients With Severe Dry Eye Syndrome Treated With Autologous Serum Eye Drops. Single-center Study.
Dry eye syndrome is a multifactorial pathology of the ocular surface. Epidemiological studies report a prevalence of 15% in adults aged between 50 and 95. Depending on the severity of the disease, different treatment strategies may be proposed. The use of autologous serum eye drops (AS) represents an interesting therapeutic alternative for the most severe forms of the disease, due to the serum's composition, which is similar to that of tears. The mechanism of action of AS is still controversial, but is probably multifactorial and seems to be based on growth factors, vitamin factors and anti-inflammatory factors. The clinical response of patients could be dependent on the protein composition of the eye drops. The investigators are aiming to highlight a difference in serum protein composition that could explain the differences in clinical response between patients treated with autologous serum eye drops and to identify the proteins that would be involved in a clinical response or non-response.
- Conditions
- Dry Eye Syndrome (DES), Dry Eye
- Being tested
- Autologous serum eye drops, Collecting data from the medical record
- Keywords
- autologous serum eye drops, dry eye disease
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous serum eye dropsOther
The proteins contained in the autologous serum eye drops will be screened and the proteins judged to be the most relevant will be quantified.
Collecting data from the medical recordOther
We will collect the following medical data :
- Oxford score
- OSDI score
- Causes of dry eye syndrome
- drug treatment history
| Study group | Role | What they receive |
|---|---|---|
| All patients newly treated with autologous serum eye drops | Experimental | To identify proteins potentially associated with clinical improvement in severe dry eye syndrome, as determined by the Oxford score. Receives: Other: Autologous serum eye drops; Other: Collecting data from the medical record |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify and assess the relative abundance of proteins present in autologous serum-based eye drops in responders and non-responders after 6 months of treatment.
Proteomic profiles will be determined by a non-targeted analysis of autologous serum eye drops using high-performance liquid chromatography coupled with high-resolution mass spectrometry. This technique makes it possible to identify as many proteins as possible in a sample, without a pre-established list of proteins to look for. The quantity of a protein is expressed as a variation in abundance, or expression level, between two different states (e.g. responder/non-responder, etc.), enabling us to define an abundance ratio between our two groups of patients. Patients with a clinical response at 6 months, defined as an improvement in Oxford score of greater than or equal to 1 point, will be considered responders.
Measured: Month 6
Secondary outcomes (3)
Improvement in dry eye symptoms after 6 months of treatment with autologous serum eye drops.
This improvement will be defined by a change in the OSDI score of 11 points. The OSDI score ranges from 0 to 100, with higher scores indicating more severe ocular surface disease symptoms and a worse outcome. A change of 11 points corresponds to the Minimal Clinically Important Difference (MCID).
Measured: From baseline to Month 6
Change in relative protein abundance in autologous serum eye drops.
Change in relative protein abundance in autologous serum eye drops measured by mass spectrometry in non-responding patients.
Measured: Month 6
Measurement of concentrations of selected proteins in autologous serum eye drops.
Protein concentrations will be quantitatively measured using protein-specific ELISA assays for each analyte.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start7 Jul 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Syndrome (DES)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elodie JACQUEROUX, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632534
- Sponsor's protocol ID
- 24CH169
- Other IDs
- ANSM
- Acronym
- Prot-CSA
- Status last verified
- Jul 2026
- First submitted
- 20 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Proteomic Factors in Patients With Severe Dry Eye Syndrome Treated With Autologous Serum Eye Drops. Single-center Study.
- ClinicalTrials.gov ID
- NCT07632534
- Acronym / sponsor ID
- Prot-CSA / 24CH169
- Conditions
- Dry Eye Syndrome (DES), Dry Eye
- Keywords
- autologous serum eye drops, dry eye disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jun 2026 (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.
Dry eye syndrome is a multifactorial pathology of the ocular surface. Epidemiological studies report a prevalence of 15% in adults aged between 50 and 95. Depending on the severity of the disease, different treatment strategies may be proposed. The use of autologous serum eye drops (AS) represents an interesting therapeutic alternative for the most severe forms of the disease, due to the serum's composition, which is similar to that of tears. The mechanism of action of AS is still controversial, but is probably multifactorial and seems to be based on growth factors, vitamin factors and anti-inflammatory factors. The clinical response of patients could be dependent on the protein composition of the eye drops. The investigators are aiming to highlight a difference in serum protein composition that could explain the differences in clinical response between patients treated with autologous serum eye drops and to identify the proteins that would be involved in a clinical response or non-response.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients newly treated with autologous serum eye drops | Experimental | Other: Autologous serum eye drops, Other: Collecting data from the medical recordTo identify proteins potentially associated with clinical improvement in severe dry eye syndrome, as determined by the Oxford score. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years
- Patients with severe dry eye with an Oxford score > 1
- Patients with dry eye syndrome refractory to conventional treatments: tear substitutes, immunosuppressive eye drops or corticosteroids.
- AS-naïve patients followed by an ophthalmologist at Saint-Etienne University Hospital
- Patients affiliated to or entitled under a social security scheme
Key exclusion criteria (4 listed)
- Severe ocular dryness due to a genetic disease
- Patients not under the care of an ophthalmologist at Saint-Etienne University Hospital.
- Patients not eligible for treatment with AS (pregnant women, anaemia, current infection, progressive disease, serological results contraindicating blood sampling).
- Patients under protective measures
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 |
|---|---|---|
| Autologous serum eye dropsThe proteins contained in the autologous serum eye drops will be screened and the proteins judged to be the most relevant will be quantified. | Other | All patients newly treated with autologous serum eye drops |
| Collecting data from the medical recordWe will collect the following medical data : * Oxford score * OSDI score * Causes of dry eye syndrome * drug treatment history | Other | All patients newly treated with autologous serum eye drops |
Primary outcome
To identify and assess the relative abundance of proteins present in autologous serum-based eye drops in responders and non-responders after 6 months of treatment.
Time frame: Month 6
Proteomic profiles will be determined by a non-targeted analysis of autologous serum eye drops using high-performance liquid chromatography coupled with high-resolution mass spectrometry. This technique makes it possible to identify as many proteins as possible in a sample, without a pre-established list of proteins to look for. The quantity of a protein is expressed as a variation in abundance, or expression level, between two different states (e.g. responder/non-responder, etc.), enabling us to define an abundance ratio between our two groups of patients. Patients with a clinical response at 6 months, defined as an improvement in Oxford score of greater than or equal to 1 point, will be considered responders.
3 secondary outcomes
Improvement in dry eye symptoms after 6 months of treatment with autologous serum eye drops.
Time frame: From baseline to Month 6
Change in relative protein abundance in autologous serum eye drops.
Time frame: Month 6
Measurement of concentrations of selected proteins in autologous serum eye drops.
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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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.
Elodie JACQUEROUX, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous serum eye drops and Collecting data from the medical record in people with Dry Eye Syndrome (DES) and Dry Eye, 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 6 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elodie JACQUEROUX, MD ((0)477828070 ext. +33, Elodie.Jacqueroux@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify and assess the relative abundance of proteins present in autologous serum-based eye drops in responders and non-responders after 6 months of treatment. (time frame: Month 6). 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 9 Jul 2026.