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Recruiting NCT07632534

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

No phase Interventional Dry Eye Syndrome (DES) Dry Eye

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous serum eye drops, Collecting data from the medical record.
Who it may be relevant to
Registry conditions: Dry Eye Syndrome (DES), Dry Eye. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT07632534 · 24CH169 · ANSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗