Study of Proteomic Factors in Patients With Severe Dry Eye Syndrome Treated With Autologous Serum Eye Drops.

NCT07632534 | Not Yet Recruiting

• 2 other identifiers: 24CH169ANSM
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Syndrome (DES); Dry Eye

Keywords

autologous serum eye drops; dry eye disease

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (3)

• Improvement in dry eye symptoms after 6 months of treatment with autologous serum eye drops.

  From baseline to Month 6

• Change in relative protein abundance in autologous serum eye drops.

  Month 6

• Measurement of concentrations of selected proteins in autologous serum eye drops.

  Month 6

Study Arms (1)

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.

Other: Autologous serum eye drops; Other: Collecting data from the medical record

Interventions

Autologous serum eye drops OTHER

The proteins contained in the autologous serum eye drops will be screened and the proteins judged to be the most relevant will be quantified.

All patients newly treated with autologous serum eye drops

Collecting data from the medical record OTHER

We will collect the following medical data : * Oxford score * OSDI score * Causes of dry eye syndrome * drug treatment history

All patients newly treated with autologous serum eye drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Elodie JACQUEROUX, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elodie JACQUEROUX, MD

CONTACT

(0)477828070; Elodie.Jacqueroux@chu-st-etienne.fr

Hélène RAINGARD, CDP

CONTACT

(0)477829703; helene.raingard@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-05

Locations

FR (1)