Clinical Trial to Determine the Effectiveness and Safety of Topical Insulin in Dry Eye

Launched by BARBARA BURGOS BLASCO · Jan 18, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of insulin eye drops for treating moderate to severe dry eye disease. The researchers want to see how well these insulin drops work compared to the standard treatment, which is cyclosporin eye drops, and a placebo, like artificial tears. The trial is currently recruiting participants aged 18 and older who have been diagnosed with dry eye disease and have been using artificial tears or hyaluronic acid gels for at least three months.

To participate, individuals must not have severe dry eye that requires immediate treatment, recent eye surgery, or other eye-related conditions that could interfere with the study. Participants will receive either the insulin drops, the standard treatment, or the placebo and will be closely monitored for any side effects and improvements in their symptoms. This study is an important step in exploring new options for managing dry eye disease, and your involvement could help improve treatment for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients older than 18 years
• • Dry eye disease diagnosis
• • Treatment with artificial tears or hyaluronic acid gels for at least 3 months
• • Signed informed consent by the patient
• • Staining equal to or greater than Oxford II
• Exclusion Criteria:
• • Under 18 years old
• • Corneal staining under Oxford II
• • Treatment for dry eye disease other than artificial tears or hyaluronic acid gels
• • Severe dry eye disease that requires immediate treatment
• • Eye surgery in the last 6 months
• • Other concomitant corneal pathology, eyelid malpositions, nasolacrimal drainage abnormalities, blinking alterations
• • Contact lenses
• • Other treatment besides artificial tears or hyaluronic acid gels
• • Visual acuity less than 0.1
• • Allergy or intolerance to any of the components included in the study
• • Modifications in systemic immunosuppressive treatment
• • Pregnancy or lactation
• • Women of childbearing age who do not use a highly effective contraceptive method
• • History of alcohol or drug abuse
• • Participation in another clinical trial in the last 30 days
• • Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination (such as mental or psychomotor retardation)