Study of Proteomic Factors in Patients With Severe Dry Eye Syndrome Treated With Autologous Serum Eye Drops. (Prot-CSA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye; Dry Eye Syndrome (DES)
• Intervention / Treatment: Other: Autologous serum eye drops; Other: Collecting data from the medical record

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elodie JACQUEROUX, MD; Phone Number: +33 (0)477828070; Email: Elodie.Jacqueroux@chu-st-etienne.fr
• Study Contact Backup: Name: Hélène RAINGARD, CDP; Phone Number: +33 (0)477829703; Email: helene.raingard@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42055
    • CHU de Saint-Etienne
    • Sub-Investigator: Marie-Caroline TRONE, MD
    • Sub-Investigator: Emera CHHUY, MD
    • Principal Investigator: Elodie JACQUEROUX, MD
    • Sub-Investigator: Freddy MOUNSEF, MD
    • Sub-Investigator: Raphaël AUGER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All patients newly treated with autologous serum eye drops; To identify proteins potentially associated with clinical improvement in severe dry eye syndrome, as determined by the Oxford score.	Other: Autologous serum eye drops; The proteins contained in the autologous serum eye drops will be screened and the proteins judged to be the most relevant will be quantified.; Other: Collecting data from the medical record; We will collect the following medical data : Oxford score; OSDI score; Causes of dry eye syndrome; drug treatment history

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	Month 6

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Elodie JACQUEROUX, MD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: dry eye disease; autologous serum eye drops
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 24CH169; ANSM (Other Identifier: 2025-A00293-46)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No