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

Study Overview
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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).

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.

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

Conditions
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Dry Eye, Insulin

Intervention / Treatment
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* Drug: Insulin
* Drug: Cyclosporins
* Drug: Artificial tears


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin<br>Topical insulin 1UI/ml 4 times a day | Drug: Insulin<br>* see arm description<br>|
| Active Comparator: Cyclosporin<br>Cyclosporin 0,05% every 12 hours | Drug: Cyclosporins<br>* see arm description<br>|
| Placebo Comparator: Artificial tears<br>Artificial tears 4 times a day | Drug: Artificial tears<br>* see arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of corneal staining from baseline to 6 months after treatment | Corneal staining will be evaluated on the slit-lamp and on slit-lamp images (masked evaluator) | From baseline to 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in dry eye symptoms from baseline to 6 months after treatment time | Dry eye symptoms will be evaluated using OSDI | From baseline to 6 months after treatment | 
| Changes in esthesiometry from baseline to 6 months after treatment time | Esthesiometry will be evaluated using an esthesiometer | From baseline to 6 months after treatment | 
| Changes in tear rupture time from baseline to 6 months after treatment time | Tear rupture time will be evaluated using the Keratograph (Oculus) | From baseline to 6 months after treatment |