Clinical Trial To Determine The Efficacy And Safety Of Insulin Eye Drops In Dry Eye In Patients With Topical Hypotensors

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the preliminary efficacy of the use of insulin eye drops in the control of dry eye disease in patients with topical hypotensors, compared to placebo (artificial tears). The main question aims to answer whether glaucoma patients treated with topical hypotensors could benefit from the use of insulin eye drops for the treatment of dry eye. Participants will be assigned to one of the two treatment arms and will be required to attend four follow-up visits (baseline, 1, 3, and 6 months).

Detailed Description
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Patients will be recruited in Madrid. Patients with dry eye disease and topical glaucoma treatment 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 Hipotensores tópicos

Conditions
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Dry Eye, Glaucoma

Intervention / Treatment
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* Drug: Insulin
* Drug: Artificial tear


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures. Patients ≥ 18 years at the screening visit. Ocular hypertension or glaucoma controlled with hypotensive treatment Diagnosis of dry eye Exclusion Criteria: Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months Changes in topical glaucoma treatment in the last 3 months Severe dry eye requiring immediate treatment Previous eye surgery, except cataract surgery more than 12 months ago Laser procedures less than 6 months ago Other concomitant ocular pathology: scarring disease of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days Eyelid disorders Use of contact lenses Other topical treatment other than dry eye and glaucoma Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients Modifications in systemic immunosuppressive treatment in the last 6 months History of alcohol or drug abuse Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit. Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or situation of the patient that does not allow examination (such as mental or psychomotor retardation). Any other disease or condition that, at the discretion of the investigator, could constitute a risk to the participant or interfere with the results of the study.

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin<br>Topical insulin 1UI/ml 4 times a day | Drug: Insulin<br>* Topical insulin 1UI/ml 4 times a day<br>|
| Placebo Comparator: Placebo (artificial tears)<br>Artificial tears 4 times a day | Drug: Artificial tear<br>* Artificial tears 4 times a day<br>|

What is the study measuring?
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Primary 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 | 

Secondary 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 | From baseline to 6 months after treatment | 
| Change in corneal aesthesiometry from baseline to 6 months after treatment | Aesthesiometry will be evaluated using Cochet Bonnet | From baseline to 6 months after treatment | 
| Change in conjunctival hyperemia from baseline to 6 months after treatment | Conjunctival hyperemia will be evaluated using Keratograph | From baseline to 6 months after treatment | 
| Change in non-invasive tear film break-up time from baseline to 6 months after treatment | Non-invasive tear film break-up time will be evaluated using Keratograph | From baseline to 6 months after treatment | 
| Change in light dispersion from baseline to 6 months after treatment | Light dispersion will be evaluated using the Optical Quality Analysis System | From baseline to 6 months after treatment | 
| Change in cytokine levels from baseline to 6 months after treatment | Cytokine leves will be evaluated using immunoassay | From baseline to 6 months after treatment | 
| Change in therapeutic compliance from baseline to 6 months after treatment | Therapeutic compliance will be evaluated using Medication adherence rating scale (MARS). The total score ranges from 0-10 with a higher score indicating better adherence. | From baseline to 6 months after treatment |