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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-19

Study Completion Date

2025-09-30

Brief Summary

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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).

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Detailed Description

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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

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Dry Eye Insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This will be a randomized controlled trial for the treatment of dry eye disease with three arms: topical insulin, topical cyclosporin (gold standard) and artificial tears (placebo)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Insulin

Topical insulin 1UI/ml 4 times a day

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

see arm description

Cyclosporin

Cyclosporin 0,05% every 12 hours

Group Type ACTIVE_COMPARATOR

Cyclosporins

Intervention Type DRUG

see arm description

Artificial tears

Artificial tears 4 times a day

Group Type PLACEBO_COMPARATOR

Artificial tears

Intervention Type DRUG

see arm description

Interventions

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Insulin

see arm description

Intervention Type DRUG

Cyclosporins

see arm description

Intervention Type DRUG

Artificial tears

see arm description

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No