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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Autologous serum eye drops

    Other intervention

    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 record

    Other intervention

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

Treatment groups

68 Participants
are divided into 1 treatment group
Group A: All patients newly treated with autologous serum eye dropsExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
Month 6

Secondary outcomes

1

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).

Time frame
From baseline to Month 6
2

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.

Time frame
Month 6
3

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.

Time frame
Month 6

Other outcomes

Sponsors and contacts

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