Topical Insulin for Ocular Surface Interface in Dry Eye Disease

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.

It had two arms (groups): Artificial Tears (placebo comparator) and Topical insulin (experimental).

Artificial tears Artificial tears 4 times a day.

Experimental: Insulin Topical insulin 1UI/ml 4 times a day.

The registry classes the interventions as drug.

More on the Plan

Patients fulfilling the selection criteria will be enrolled from eye OPD of KTH.

A written informed consent will be taken after explaining the purpose of study.

Data will be collected on a pre-designed structured proforma.

Demographic data including age, gender, educational status, socioeconomic status will be noted.

Who Took Part

The registry lists 128 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: Aged 18 years and above.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: under 18 years old.

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2025-04-14 with completion listed for 2026-04-19.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: OSDI Score (time frame: Baseline to Week 12).

It also tracked 2 secondary outcomes, for example SCHIRMER TEST and Tear Film Break up Time.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 128 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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