Impact of Filtration on Autologous Serum Eye Drops

What Was Tested

The trial (not phased) is built around IGF-1 LR3.

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.

It had 1 arm (groups): Serum (experimental).

Analyse sera.

The registry classes the interventions as biological.

More on the Plan

Sterility, which is a mandatory specification for eye drops, represents a critcial step in their manufacturing process.

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.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients covered by health insurance. Patients diagnosed with dry eyes syndrome, who have not responded to conventionnal treatments. Free, informed, written and signed consent.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: person incapable of consent; legal guardianship or wardship; patient who does not wish to know the results of serological tests.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when IGF-1 LR3 was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-04-13 with completion listed for 2026-05-18.

It ran at 1 site in France.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Differences in concentrations of active molecules (time frame: At the inclusion).

It also tracked 5 secondary outcomes, for example Concentration of active molecules, Physiological parameters of patients to graduate chronical dry eye disease, OSDI quality of life questionnary, Description of the concentrations of active molecules in the serum before filtration and Description of the proposed patient pathway and manufacturing process.

What This Means in Plain Language

Put simply, this is a not phased trial of IGF-1 LR3 in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the IGF-1 LR3 compound page, all human trials.