Dry Eye Syndrome (DES)
Conditions
Keywords
Dry Eye Syndrome, Autologous serum, eye drops, filtration, pilot project, active molecules of autologous serum, TGF β, IGF 1, EGF, fibronectin, vitamin A
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.
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.
Interventions
BIOLOGICALSerum 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
Sponsors
University Hospital, Limoges
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
The biological analyses are carried out blindly
Intervention model description
Pilot study, descriptive study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in concentrations of active molecules | 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
| Measure | Time frame | Description |
|---|---|---|
| Concentration of active molecules | 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. |
| Physiological parameters of patients to graduate chronical dry eye disease | 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 |
| OSDI quality of life questionnary | At the inclusion | — |
| Description of the concentrations of active molecules in the serum before filtration. | At the inclusion | Average value of the concentrations measured in duplicate for each active compound in a given patient. |
| Description of the proposed patient pathway and manufacturing process. | 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMaxime Rocher, Dr
University Hospital, Limoges
Outcome results
None listed