Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

This is a parallel randomized controlled trial for the treatment of dry eye disease.

Topical insulin drops will be compared to the current gold standard treatment, cyclosporin and placebo (artificial tears).

It had three arms (groups): Insulin (experimental), Cyclosporin (active comparator) and Artificial tears (placebo comparator).

Topical insulin 1UI/ml 4 times a day.

Artificial tears 4 times a day.

The registry classes the interventions as drug.

More on the Plan

Patients will be recruited in Madrid.

Patients with dry eye disease and no topical treatment other than artificial tears will be identified through the Ophthalmology clinic.

They will be directly referred to a physician who is participating in this study.

Who Took Part

The registry lists 116 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 older than 18 years. Dry eye disease diagnosis. Treatment with artificial tears or hyaluronic acid gels for at least 3 months. Signed informed consent by the patient. Staining equal to or greater than Oxford II.

The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: under 18 years old; corneal staining under oxford ii; treatment for dry eye disease other than artificial tears or hyaluronic acid gels.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2022-10-19 with completion listed for 2025-11-05.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change of corneal staining from baseline to 6 months after treatment (time frame: From baseline to 6 months after treatment).

It also tracked 3 secondary outcomes, for example Changes in dry eye symptoms from baseline to 6 months after treatment time, Changes in esthesiometry from baseline to 6 months after treatment time and Changes in tear rupture time from baseline to 6 months after treatment time.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 116 people.

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.