Impact of Filtration on Autologous Serum Eye Drops

NCT07407101 | Completed

• 1 other identifier: 87RI25_003 (IFILCOSA)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; EGF; fibronectin; vitamin A

Outcome Measures

Primary Outcomes (1)

• 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.

  At the inclusion

Secondary Outcomes (5)

• Concentration of active molecules

  At the inclusion

• Physiological parameters of patients to graduate chronical dry eye disease

  At the inclusion

• OSDI quality of life questionnary

  At the inclusion

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

  At the inclusion

• Description of the proposed patient pathway and manufacturing process.

  From the inclusion to the end of results 7 days later

Study Arms (1)

Serum

EXPERIMENTAL

analyse sera

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

Interventions

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

Serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

CHU Limoges

Limoges, 87042, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Insulin-Like Growth Factor I; Epidermal Growth Factor; Fibronectins; Vitamin A

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Somatomedins; Insulin-Like Peptides; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Blood Proteins; Proteins; Biological Factors; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; EGF Family of Proteins; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Serum Globulins; Globulins; Membrane Proteins; Extracellular Matrix Proteins; Scleroproteins; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological

Study Officials

• Maxime Rocher, Dr

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The biological analyses are carried out blindly
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study, descriptive study

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 12, 2026
• Study Start: April 13, 2026
• Primary Completion: May 18, 2026
• Study Completion: May 18, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

FR (1)