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Study on the Effectiveness and Safety of Insulin, Ciclosporin, and Benzalkonium Chloride in Patients with Moderate to Severe Dry Eye Disease

Verified siteRegistered drugNo placebo
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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 effectiveness and safety of using insulin eye drops for treating dry eye disease. Dry eye disease is a common condition where the eyes do not produce enough tears or the tears evaporate too quickly, leading to discomfort and vision problems. The study will explore whether insulin, a hormone commonly used to manage blood sugar levels in diabetes, can help control moderate to severe cases of this eye condition when applied as eye drops.

Participants in the study will receive either the insulin eye drops or a placebo for a period of six months. The study will also involve the use of artificial tears, which are eye drops that help to lubricate the eyes, and ciclosporin, a medication that can reduce inflammation in the eyes. The aim is to see if insulin eye drops can improve symptoms and eye health compared to these other treatments.

Throughout the study, changes in eye health will be monitored, including improvements in symptoms and any side effects experienced by participants. The goal is to determine if insulin eye drops can be a safe and effective treatment option for those suffering from dry eye disease. Participants will be regularly assessed to track their progress and any changes in their condition over the course of the study.

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 trial

    Upon joining the clinical trial, you will be asked to confirm your eligibility. This includes being over 18 years old, having a diagnosis of dry eye disease, and having used artificial tears or hyaluronic acid gels for at least 3 months.

    You will need to provide signed informed consent, which means you agree to participate after understanding the trial details.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to establish a baseline for your dry eye disease. This includes measuring corneal staining, which is a way to assess the health of the surface of your eye.

    Other assessments may include checking your symptoms, tear rupture time, and conjunctival hyperemia, which is the redness of the eye.

  3. Step 3

    Medication administration

    You will begin using insulin eye drops as part of the trial. These are administered for ophthalmic use, meaning they are applied directly to the eyes.

    The dosage and frequency of the eye drops will be explained to you by the trial staff. It is important to follow these instructions carefully.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, your condition will be monitored regularly. This includes checking for any changes in your symptoms and the health of your eyes.

    You will be asked to report any adverse effects or changes in your condition to the trial staff.

  5. Step 5

    Final assessment

    At the end of the trial period, which lasts for 6 months, a final assessment will be conducted.

    This will involve measuring any changes in corneal staining, symptoms, tear rupture time, and conjunctival hyperemia compared to the initial assessment.

Who can join the trial?

5 criteria

  • Patients must be older than 18 years.
  • Must have a diagnosis of dry eye disease.
  • Must have been treated with artificial tears or hyaluronic acid gels for at least 3 months. These are treatments used to relieve dry eyes.
  • Must provide a signed informed consent. This means the patient agrees to participate in the study after being informed about it.
  • Must have an eye condition with staining equal to or greater than Oxford II. This refers to a specific level of eye surface damage that can be seen with special dyes during an eye exam.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing dry eye disease cannot participate.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot give consent themselves, cannot participate.
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Investigated drugs

Insulin Eye Drops are being tested in this clinical trial to see if they can help people with moderate to severe dry eye disease. Insulin is a hormone that is usually known for its role in controlling blood sugar levels. In this trial, it is used in the form of eye drops to see if it can provide relief from the symptoms of dry eye by promoting healing and reducing inflammation on the surface of the eye. The goal is to determine if these eye drops can effectively improve the condition of dry eyes and ensure they are safe for use.

What is already known about the treatment

Insulin Eye Drops – Insulin eye drops are administered topically, meaning they are applied directly to the surface of the eye. Currently, they are being studied in clinical trials to assess their effectiveness and safety for treating moderate to severe dry eye disease. The main therapeutic indication for these eye drops is to alleviate symptoms associated with dry eye, a condition where the eyes do not produce enough tears or the tears evaporate too quickly. At the molecular level, insulin is thought to help by promoting healing and reducing inflammation on the eye's surface. Pharmacologically, insulin is classified as a hormone, but in this context, it is being explored for its potential benefits in eye health.

Investigated diseases

Dry eye disease – Dry eye disease is a condition where the eyes do not produce enough tears or the tears evaporate too quickly, leading to dryness and irritation. It often results in a gritty or burning sensation in the eyes, redness, and blurred vision. The disease progresses as the tear film becomes unstable, causing inflammation and damage to the eye's surface. Over time, this can lead to increased discomfort and sensitivity to light. The condition can fluctuate, with periods of worsening symptoms. Environmental factors, such as wind or screen time, can exacerbate the symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518376-31-00Protocol code1INSULINAOJOSECO2021Estimated enrolment120 patientsSponsorHospital Clinico San Carlos

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).