Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors

What Was Tested

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

Participants will be assigned to one of the two treatment arms and will be required to attend four follow-up visits (baseline, 1, 3, and 6 months).

It had two arms (groups): Insulin (experimental) and Placebo (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 topical glaucoma treatment will be identified through the Ophthalmology clinic.

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

Who Took Part

100 planned participants were the target.

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 who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures. Patients ≥ 18 years at the screening visit. Ocular hypertension or glaucoma controlled with hypotensive treatment. Diagnosis of dry eye.

The full record lists 4 inclusion and 15 exclusion criteria; among the exclusions: uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months; changes in topical glaucoma treatment in the last 3 months; severe dry eye requiring immediate treatment.

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: outcomes assessor.

It started in 2023-02-08 with completion listed for 2026-02-08.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in dry eye symptoms from baseline to 6 months after treatment time (time frame: From baseline to 6 months after treatment).

It also tracked 7 secondary outcomes, for example Change of corneal staining from baseline to 6 months after treatment, Change in corneal aesthesiometry from baseline to 6 months after treatment, Change in conjunctival hyperemia from baseline to 6 months after treatment, Change in non-invasive tear film break-up time from baseline to 6 months after treatment, Change in light dispersion from baseline to 6 months after treatment and Change in cytokine levels from baseline to 6 months after treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.