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Completed

NCT Number: NCT07407101

Impact of Filtration on Autologous Serum Eye Drops

Dry eye disease accounts for nearly 25% of ophthalmology consultations, making it a commonly encountered condition. When conventional treatments fail autologous serum in the form of eye drops, have been proposed as a therapeutic option. With the aim of standardizing the preparation of autologous serum eye drops in France, the main objective is to describe the absolute and relative differences (before and after filtration) in the concentrations of active molecules in the autologous serum of patients suffering from severe dry eye disease.

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Key information

Conditions

Dry Eye Syndrome (DES) 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 Limoges

Limoges, 87042, France

About this study

Sterility, which is a mandatory specification for eye drops, represents a critcial step in their manufacturing process. A review of the literature shows that 62% of articles (n=42) addressing the manufacturing process of autologous serum eye drops do not include a filtration step. Among those reporting filtration, slightly over 9% do not specify the porosity used, 4.8% use filters with a porosity of 0.45µm (clarifying filtration), and slightly over 23% use filters with a porosity ≤ 0.22µm ( sterilizing filtration). Several molecules present in autologous serum have been described in the literature, but five are widely recognized as the main contributors to its therapeutic efficacy: EGF, TGF-ß, IGF-1, Fibronectin, and Vitamin A. The impact of sterilizing filtration on the concentrations of thesemolecules in the final serum used for eye drop preparation therefore warrants investigation. Ten patients will be recruited from the ophthalmology department. A pre-screening phase will be conducted to identify eligible patients and propose the study participation. A dedicated follow-up consultation will be organized for inclusion. Serological tests will be performed on the blood samples of eligible patients. Only patients with negative serology for HIV, HBV, HCV and Treponema pallidum will be included. Their serum will be processed, at the Pharmaceutical Preparations Unit, to produce multiple aliquots following coagulation and centrifugation, with subsequentfiltration using 2 different filter materials, with 2 different porosities, or no filtration. These aliquots will then be sent to the Biochemistry department and Pharmacology department for the quantitative analysis of molecules of interest.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients
  • patients covered by health insurance
  • patients managed by the Ophtalmology Department of the University Hospital of Limoges
  • patients diagnosed with dry eyes syndrome, who have not responded to conventionnal treatments
  • free, informed, written and signed consent

Exclusion criteria

  • person incapable of consent
  • legal guardianship or wardship
  • patient who does not wish to know the results of serological tests

Secondary exclusion criteria:

  • a positive serology for at least of of the following agents (HIV, HCV, HBV or syphilis)

Treatment and study plan

Serum dosage of TGF-β, IGF-1, EGF, Fibronectin and Vitamin A

Biological

Dosage of active molecules of autologous serum: TGF β, IGF 1, EGF, fibronectin and vitamin A

Primary outcomes

  1. Differences in concentrations of active molecules

    Time frame: At the inclusion

    Absolute and relative differences in concentrations, before/after filtration (clarifying or sterilizing, and using polyethersulfone or cellulose acetate), of the following active molecules: EGF, TGF-ß, IGF-1, Fibronectin, and Vitamin A.

Secondary outcomes

  1. Concentration of active molecules

    Time frame: At the inclusion

    The impact of filtration is considered significant if the relative decrease in concentrations following filtration is ≥ 7,5% given the galenic form.

  2. Physiological parameters of patients to graduate chronical dry eye disease

    Time frame: At the inclusion

    Symptoms; therapeutic management of dry eye syndrom; diagnostic tests performed and contributory elements to the diagnosis: slit lamp examination and standard Oxford scale for fluorecein staining; graduate in severe intermediate and early stages

  3. OSDI quality of life questionnary

    Time frame: At the inclusion

  4. Description of the concentrations of active molecules in the serum before filtration.

    Time frame: At the inclusion

    Average value of the concentrations measured in duplicate for each active compound in a given patient.

  5. Description of the proposed patient pathway and manufacturing process.

    Time frame: From the inclusion to the end of results 7 days later

    Record the time taken for each step of the process, from sample collection to the availability of the assay results, as well as any incidents that occurred or comments from the personnel involved at each stage.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

Optimization of Autologous Serum Eye Drops: Study of Filtration on Active Molecule Concentration in Patients With Dry Eye Disease (IFilCoSA)

Acronym: IFILCOSA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
May 29, 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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