RecruitingPhase 4NCT06017362

Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors

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


Sponsor

Barbara Burgos Blasco

Enrollment

100 participants

Start Date

Feb 8, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether insulin eye drops can relieve dry eye symptoms in people who already use eye drops for glaucoma or high eye pressure (ocular hypertension). **You may be eligible if...** - You are 18 or older - You have controlled glaucoma or high eye pressure being managed with eye drops - You have been diagnosed with dry eye **You may NOT be eligible if...** - Your glaucoma is not well controlled or your eye drop regimen is expected to change soon - You changed your glaucoma medications within the last 3 months - You have severe dry eye needing immediate treatment - You had eye surgery (other than cataract surgery) or laser treatment recently - You use contact lenses - You have another eye condition (like uveitis, scarring, or recent infection) - You are pregnant, have a history of drug or alcohol abuse, or have a serious medical condition that could interfere Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInsulin

Topical insulin 1UI/ml 4 times a day

DRUGArtificial tear

Artificial tears 4 times a day


Locations(1)

Hospital Clinico San Carlos

Madrid, Madrid, Spain

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NCT06017362


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