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NCT Number: NCT07632534

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

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.

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Key information

Conditions

Dry Eye Syndrome (DES) Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Elodie JACQUEROUX, MD

PRINCIPAL_INVESTIGATOR

Emera CHHUY, MD

SUB_INVESTIGATOR

Freddy MOUNSEF, MD

SUB_INVESTIGATOR

Marie-Caroline TRONE, MD

SUB_INVESTIGATOR

Raphaël AUGER, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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.

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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).

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

    Time frame: Month 6

    Change in relative protein abundance in autologous serum eye drops measured by mass spectrometry in non-responding patients.

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

    Time frame: Month 6

    Protein concentrations will be quantitatively measured using protein-specific ELISA assays for each analyte.

Study contacts

Contact information is provided by the study sponsor or research team.

Elodie JACQUEROUX, MD

CONTACT

[email protected]

(0)477828070 ext. +33

Hélène RAINGARD, CDP

CONTACT

[email protected]

(0)477829703 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: Prot-CSA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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