Impact of Filtration on Autologous Serum Eye Drops (IFILCOSA)

May 28, 2026 updated by: University Hospital, Limoges

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • CHU Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Serum
analyse sera
Biological: Serum dosage of TGF-β, IGF-1, EGF, Fibronectin and Vitamin A
Dosage of active molecules of autologous serum: TGF β, IGF 1, EGF, fibronectin and vitamin A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the inclusion
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
At the inclusion
OSDI quality of life questionnary
Time Frame: At the inclusion
At the inclusion
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.
At the inclusion
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.
From the inclusion to the end of results 7 days later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: Maxime Rocher, Dr, University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2026

Primary Completion (Actual)

May 18, 2026

Study Completion (Actual)

May 18, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RI25_003 (IFILCOSA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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