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

Barbara Burgos Blasco

Status and phase: Enrolling; Phase 4

Conditions: Insulin; Dry Eye

Treatments: Drug: Cyclosporins; Drug: Artificial tears; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT05692739

22/211-EC_M

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Insulin

Experimental group

Description:

Topical insulin 1UI/ml 4 times a day

Treatment:

Drug: Insulin

Cyclosporin

Active Comparator group

Description:

Cyclosporin 0,05% every 12 hours

Treatment:

Drug: Cyclosporins

Artificial tears

Placebo Comparator group

Description:

Artificial tears 4 times a day

Treatment:

Drug: Artificial tears