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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-08

Study Completion Date

2026-02-08

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).

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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.

Conditions

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Dry Eye Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Insulin

Topical insulin 1UI/ml 4 times a day

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

Topical insulin 1UI/ml 4 times a day

Placebo (artificial tears)

Artificial tears 4 times a day

Group Type PLACEBO_COMPARATOR

Artificial tear

Intervention Type DRUG

Artificial tears 4 times a day

Interventions

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Insulin

Topical insulin 1UI/ml 4 times a day

Intervention Type DRUG

Artificial tear

Artificial tears 4 times a day

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No