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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Limoges

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 18, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

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