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Recruiting Phase 4

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

NCT06017362 · tracked via the Priya Life Science Spain tracker
Sponsor
Barbara Burgos Blasco
Phase
Phase 4
Started
2023-02-08
Last updated
2024-10-22

Condition(s) studied

Dry EyeGlaucoma

Investigational drug(s) / intervention(s)

InsulinArtificial tear →

Insulin: Topical insulin 1UI/ml 4 times a day

Artificial tear: Artificial tears 4 times a day

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Changes in dry eye symptoms from baseline to 6 months after treatment time — From baseline to 6 months after treatment
    Dry eye symptoms will be evaluated using OSDI

Trial sites (1)

FacilityCityRegionStatus
Hospital Clinico San Carlos Madrid Madrid Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06017362 on ClinicalTrials.gov ↗ ← All trials in Spain