Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye.

What Was Tested

The trial (phase 3) is built around Insulin (regular human).

Introduction: Dry Eye Disease (DED) of autoimmune origin is often severe and resistant to conventional treatments, necessitating alternative therapeutic options.

Autologous Serum Eye Drops (ASED) have gained recognition for their biochemical and biomechanical properties, which closely mimic those of human tears.

It had two arms (groups): Insulin (active comparator) and Sham (sham comparator).

1 UI/ml of insulin added to the autologous serum formulation.

Autologous Serum without insulin.

The registry classes the interventions as drug and other.

Who Took Part

25 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.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

Those kept unaware of assignments: participant.

It started in 2024-02-01 with completion listed for 2025-06-01.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: OSDI (time frame: From enrollment, 10 days and 30 days after starting treatment).

It also tracked 4 secondary outcomes, for example Ocular surface staining (Van-Bijsterveld score), Schirmer test, non-invasive tear break-up time (NITBUT) and Tear meniscus height (TMH).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 25 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 Insulin (regular human) compound page, all human trials.