Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus

What Was Tested

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

The cornea plays a fundamental role in vision, being a complex tissue essential for ocular health.

In ophthalmological practice, there are situations such as corneal crosslinking, where damage to the corneal epithelium occurs.

It had two arms (groups): Group A (active comparator) and Group B (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Once indicated for crosslinking, participants will be informed by the assistants of the Keratoconus Clinic about the study.

Those who, after being informed about all aspects of the crosslinking procedure and the study, and sign the Informed Consent Form, will be randomly divided into two groups of equal size and stratified by gender.

The corneal crosslinking will be performed according to the standardized protocol of the UNICAMP Ophthalmology Department by third-year residents, supervised by attending physicians and faculty members.

The procedure will be carried out in an outpatient setting.

Who Took Part

36 planned participants were the target.

It was open to people of any sex aged from 14 years with no upper age limit.

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

Examples of who could join: Patients with a diagnosis of keratoconus, indicated for corneal crosslinking.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: diabetes mellitus; severe dry eye; limbal stem cell deficiency.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2024-08-01 with completion listed for 2025-10-01.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Corneal Epithelial Healing Rate (time frame: 7 days).

It also tracked 2 secondary outcomes, for example Endothelial cell count and Incidence of corneal haze.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 36 people.

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

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.