NCT05692739

Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye

Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Ojo Seco

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Barbara Burgos Blasco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a parallel randomized controlled trial for the treatment of dry eye disease. The main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. Topical insulin drops will be compared to the current gold standard treatment, cyclosporin and placebo (artificial tears).

Detailed description

Patients will be recruited in Madrid. Patients with dry eye disease and no topical treatment other than artificial tears will be identified through the Ophthalmology clinic. They will be directly referred to a physician who is participating in this study.

Conditions

• Dry Eye
• Insulin

Interventions

Type	Name	Description
DRUG	Insulin	see arm description
DRUG	Cyclosporins	see arm description
DRUG	Artificial tears	see arm description

Timeline

• Start date: 2022-10-19
• Primary completion: 2025-11-05
• Completion: 2025-11-05
• First posted: 2023-01-20
• Last updated: 2026-03-05

Locations

1 site across 1 country: Spain