Study of Proteomic Factors in Patients With Severe Dry Eye Syndrome Treated With Autologous Serum… (NCT07632534) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of Proteomic Factors in Patients With Severe Dry Eye Syndrome Treated With Autologous Serum Eye Drops.
France68 participantsStarted 2026-06
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at why some people respond well to autologous serum eye drops and others don't — does my specific type or severity of dry eye syndrome suggest I'd be more likely to be a responder based on what's already known?
2Since this trial is listed as 'not yet recruiting,' how long might it be before it actually opens, and is waiting for it a realistic option given how severe my dry eye symptoms are right now?
3The study involves analyzing proteins in autologous serum eye drops over 6 months — what does that process actually involve for me as a patient, and how often would I need to come in for visits or provide samples?
4Autologous serum eye drops aren't widely available everywhere — if this study is where I'd access them, what happens to my treatment after the 6-month study period ends if the drops are helping me?
5Before considering this trial, are there standard treatments for severe dry eye that I haven't tried yet that might be worth attempting first, especially since this study is still in an observational phase rather than testing a new treatment head-to-head?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: Month 6
Trial details
NCT IDNCT07632534
SponsorCentre Hospitalier Universitaire de Saint Etienne