Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.

What Was Tested

This registered phase 2, phase 3 trial tested Insulin (regular human).

Many diseases can affect corneal nerves.

Corneas that lack normal sensation are considered neurotrophic.

Neurotrophic corneas are predisposed to persistent epithelial defects, recurrent erosions, and corneal ulcers.

It had two arms (groups): Topical insulin (experimental) and Tarsorrhaphy (active comparator).

Patients in this group will receive a temporary, central tarsorrhaphy and will not use additional eye drops.

The registry classes the interventions as drug and procedure.

More on the Plan

Purpose: To trial topical insulin drops to promote healing in neurotrophic keratitis that has been refractory to conventional management versus tarsorrhaphy.

Justification: Several experiments support the use of insulin for the promotion of corneal epithelial healing.

Few case studies describe the use of topical insulin in the absence of other concurrent treatments for neurotrophic keratitis.

Objectives: Through use of topical insulin, promotion of corneal healing in cases where conventional methods have failed.

Who 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: Diagnosis of neurotrophic keratitis with persistent epithelial defect that has been refractory to conventional treatments for at least 2 weeks. 18 years or older. Able to provide informed consent. Failed other conventional treatments for neurotrophic keratitis. Understanding and accepting of use of topical insulin alone.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: less than 18 years old; pregnant or breastfeeding women; unable to provide informed consent.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-06-01 with completion listed for 2023-10-18.

It ran at 6 sites in Canada (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time to re-epithelialization of neurotrophic ulcer (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Insulin (regular human) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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