Dry Eye Syndrome (DES)IFILCOSANCT07407101
Impact of Filtration on Autologous Serum Eye Drops
A study testing Serum dosage of TGF-β, IGF-1, EGF, Fibronectin and Vitamin A in people with Dry Eye Syndrome (DES), run by University Hospital, Limoges at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome (DES)
- What is being tested?
- Serum dosage of TGF-β, IGF-1, EGF, Fibronectin and Vitamin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2026to 18 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dry Eye Syndrome (DES)
- Being tested
- Serum dosage of TGF-β, IGF-1, EGF, Fibronectin and Vitamin A
- Keywords
- Dry Eye Syndrome, Autologous serum, eye drops, filtration, pilot project, active molecules of autologous serum, TGF β, IGF 1, EGF, fibronectin, vitamin A
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum dosage of TGF-β, IGF-1, EGF, Fibronectin and Vitamin ABiological
Dosage of active molecules of autologous serum: TGF β, IGF 1, EGF, fibronectin and vitamin A
| Study group | Role | What they receive |
|---|---|---|
| Serum | Experimental | analyse sera Receives: Biological: Serum dosage of TGF-β, IGF-1, EGF, Fibronectin and Vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in concentrations of active molecules
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.
Measured: At the inclusion
Secondary outcomes (5)
Concentration of active molecules
The impact of filtration is considered significant if the relative decrease in concentrations following filtration is ≥ 7,5% given the galenic form.
Measured: At the inclusion
Physiological parameters of patients to graduate chronical dry eye disease
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
Measured: At the inclusion
OSDI quality of life questionnary
Measured: At the inclusion
Description of the concentrations of active molecules in the serum before filtration.
Average value of the concentrations measured in duplicate for each active compound in a given patient.
Measured: At the inclusion
Description of the proposed patient pathway and manufacturing process.
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.
Measured: From the inclusion to the end of results 7 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start13 Apr 2026
- Primary completion18 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Syndrome (DES)Studies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study, descriptive study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime Rocher, Dr, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407101
- Sponsor's protocol ID
- 87RI25_003 (IFILCOSA)
- Acronym
- IFILCOSA
- Status last verified
- May 2026
- First submitted
- 19 Jan 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Autologous Serum Eye Drops: Study of Filtration on Active Molecule Concentration in Patients With Dry Eye Disease (IFilCoSA)
- ClinicalTrials.gov ID
- NCT07407101
- Acronym / sponsor ID
- IFILCOSA / 87RI25_003 (IFILCOSA)
- Conditions
- Dry Eye Syndrome (DES)
- Keywords
- Dry Eye Syndrome, Autologous serum, eye drops, filtration, pilot project, active molecules of autologous serum, TGF β, IGF 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study, descriptive study
| Arm | Type | Receives |
|---|---|---|
| Serum | Experimental | Biological: Serum dosage of TGF-β, IGF-1, EGF, Fibronectin and Vitamin Aanalyse sera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- person incapable of consent
- legal guardianship or wardship
- patient who does not wish to know the results of serological tests
- a positive serology for at least of of the following agents (HIV, HCV, HBV or syphilis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum dosage of TGF-β, IGF-1, EGF, Fibronectin and Vitamin ADosage of active molecules of autologous serum: TGF β, IGF 1, EGF, fibronectin and vitamin A | Biological | Serum |
Primary outcome
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.
5 secondary outcomes
Concentration of active molecules
Time frame: At the inclusion
Physiological parameters of patients to graduate chronical dry eye disease
Time frame: At the inclusion
OSDI quality of life questionnary
Time frame: At the inclusion
Description of the concentrations of active molecules in the serum before filtration.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Dry Eye Syndrome (DES)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxime Rocher, Dr principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum dosage of TGF-β, IGF-1, EGF, Fibronectin and Vitamin A in people with Dry Eye Syndrome (DES), run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in concentrations of active molecules (time frame: At the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.