Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Patients who provide written willing to sign a consent form 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Insulin

Topical insulin 1UI/ml 4 times a day

DRUG

Artificial tear

Artificial tears 4 times a day

Locations (1)

Hospital Clinico San Carlos
Madrid, Madrid, Spain