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Study on Insulin Eye Drops for Treating Dry Eye in Patients Using Topical Hypotensors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for dry eye disease, a condition where the eyes do not produce enough tears or the tears evaporate too quickly, leading to discomfort and vision problems. The study will test the use of insulin eye drops to see if they can help manage dry eye symptoms in patients who are already using medications called topical hypotensors, which are often used to treat conditions like ocular hypertension or glaucoma. The trial will compare the effects of insulin eye drops to a placebo, which in this case is artificial tears.

The purpose of the study is to evaluate how effective and safe insulin eye drops are in controlling dry eye disease. Participants will be asked to use the eye drops over a period of six months. During this time, researchers will monitor changes in symptoms and other eye health indicators, such as corneal staining, which is a test to check for damage on the surface of the eye, and conjunctival hyperemia, which refers to redness of the eye. The study will also look at how well the tear film, the thin layer of fluid covering the eye, holds together over time.

Throughout the study, participants will have regular check-ups to assess their eye health and any changes in their condition. The trial will also track any side effects experienced by participants and how well they adhere to their existing hypotensive treatment. The study aims to provide valuable information on whether insulin eye drops can be a beneficial treatment option for those suffering from dry eye disease while using topical hypotensors.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate and understand the study's requirements.

    You must be at least 18 years old and have a diagnosis of dry eye disease. Additionally, you should have ocular hypertension or glaucoma that is controlled with hypotensive treatment.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to establish a baseline for your dry eye symptoms. This will help in comparing changes over the course of the study.

    Various tests may be performed to evaluate your eye condition, including corneal staining and tear film break-up time.

  3. Step 3

    Medication administration

    You will be assigned to receive either insulin eye drops or a placebo (artificial tears).

    The eye drops are to be administered ophthalmically (applied to the eyes) as per the study's instructions. The exact dosage and frequency will be provided by the study team.

  4. Step 4

    Ongoing monitoring

    Throughout the study, regular visits will be scheduled to monitor your condition and any changes in symptoms.

    These visits will include assessments of corneal staining, conjunctival hyperemia, and other eye health indicators.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the changes in your dry eye symptoms.

    The study aims to measure changes from the baseline to six months after treatment, including any adverse effects experienced.

Who can join the trial?

4 criteria

  • Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures.
  • Patients who are 18 years or older at the screening visit.
  • Patients with ocular hypertension or glaucoma that is controlled with hypotensive treatment. Ocular hypertension means higher than normal pressure in the eyes, and glaucoma is a condition that can damage the optic nerve, often due to high eye pressure.
  • Patients with a diagnosis of dry eye.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with dry eye disease cannot participate.
  • Patients who are not using topical hypotensors (medications applied to the eye to lower pressure) cannot participate.
  • Patients who are under the age of 18 cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
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Investigated drugs

Insulin Eye Drops are being tested in this clinical trial to see if they can help with dry eye disease. Dry eye disease is a condition where your eyes do not produce enough tears, or the tears evaporate too quickly, leading to discomfort and vision problems. Insulin, commonly known for its role in managing blood sugar levels, is being used in this trial in the form of eye drops. The idea is that insulin might help improve the health of the eye surface and increase tear production, providing relief from dry eye symptoms.

What is already known about the treatment

Insulin Eye Drops – Insulin eye drops are administered directly into the eyes as a liquid solution. They are currently being studied in clinical trials to assess their effectiveness and safety for treating dry eye disease, particularly in patients who are already using topical hypotensive medications. The main therapeutic indication for these eye drops is to alleviate symptoms of dry eye disease. At the molecular level, insulin is thought to help by promoting healing and reducing inflammation in the eye's surface tissues. Insulin eye drops fall under the pharmacological classification of ophthalmic agents.

Investigated diseases

Dry eye disease – This condition occurs when the eyes do not produce enough tears or when the tears evaporate too quickly, leading to dryness and irritation. It can cause symptoms such as a gritty sensation, burning, redness, and blurred vision. The disease progresses as the tear film becomes unstable, leading to inflammation and damage to the surface of the eye. Over time, this can result in increased discomfort and potential complications with vision. The severity of symptoms can vary, and they may worsen in certain environments, such as windy or dry conditions. The condition can affect daily activities like reading or using a computer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518407-22-00Protocol code01INSULINAGLAUCOMA20Estimated enrolment100 patientsSponsorHospital Clinico San Carlos

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