Study of Insulin Eye Drops Compared to Artificial Tears for Treating Moderate to Severe Dry Eye Disease

What this Trial Is About

Researchers are evaluating the use of topical insulin eye drops compared to artificial tears for treating moderate to severe dry eye disease. This randomized controlled trial aims to study the safety and effectiveness of insulin drops in improving the ocular surface over a one-year period. The trial is conducted in a clinical setting where patients with dry eye disease are carefully selected based on specific diagnostic tests. Participants will be randomly assigned to one of two groups one group will use artificial tears four times daily as a control, while the other group will use topical insulin eye drops at a concentration of 1 UIml, also four times daily. The treatments are delivered via white, unlabeled eye droppers to keep participants unaware of their assigned group. Follow-up visits will occur at 4, 8, and 12 weeks to monitor treatment effects. During the study, participants will undergo detailed eye examinations including visual acuity, refraction, slit-lamp exams, corneal staining, Schirmer test, and tear breakup time TBUT. The main outcome measured is the Ocular Surface Disease Index OSDI score at 12 weeks. Secondary outcomes include TBUT and Schirmer test results. All previous dry eye medications will be stopped before starting the trial, and safety and adherence will be monitored throughout.

Evaluating the Efficacy of Topical Insulin for the Restoration of Ocular Surface Interface in Dry Eye Disease.