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

2. juni 2026 opdateret af: Centre Hospitalier Universitaire de Saint Etienne

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

68

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Frankrig
      • Saint-Etienne, Frankrig, 42055
        • CHU de Saint-Etienne
        • Underforsker:
          • Marie-Caroline TRONE, MD
        • Underforsker:
          • Emera CHHUY, MD
        • Ledende efterforsker:
          • Elodie JACQUEROUX, MD
        • Underforsker:
          • Freddy MOUNSEF, MD
        • Underforsker:
          • Raphaël AUGER, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: Month 6
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Improvement in dry eye symptoms after 6 months of treatment with autologous serum eye drops.
Tidsramme: From baseline to Month 6
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.
Tidsramme: Month 6
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.
Tidsramme: Month 6
Protein concentrations will be quantitatively measured using protein-specific ELISA assays for each analyte.
Month 6

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Efterforskere

  • Ledende efterforsker: Elodie JACQUEROUX, MD, CHU de Saint-Etienne

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 24CH169
  • ANSM (Anden identifikator: 2025-A00293-46)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Tørre øjne

Kliniske forsøg med Autologous serum eye drops

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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