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Study on Insulin Eye Drops for Treating Persistent Corneal Epithelial Defect in Patients with Neurotrophic or Chronic Ocular Surface Diseases

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 a condition known as persistent corneal epithelial defect. This condition affects the surface of the eye, where the outermost layer of the cornea does not heal properly. The study is testing the effectiveness and safety of using insulin eye drops as a treatment. Insulin, commonly known for its role in managing diabetes, is being explored here in a new form as eye drops to help heal the corneal surface.

The purpose of the study is to compare the insulin eye drops with the standard treatment, which involves using autologous serum eye drops. These are eye drops made from a patient's own blood. The trial will observe how well the insulin eye drops work in healing the corneal defect, especially in cases where the defect is due to nerve damage or long-term eye surface diseases.

Participants in the study will receive either the insulin eye drops or the standard treatment. The study will monitor the healing process over a period of time to see if the corneal defect closes completely. The trial aims to determine how quickly the healing occurs and whether the insulin eye drops are as effective or more effective than the current standard treatment. The study will also look at other factors such as age, sex, and previous eye conditions to understand their impact on the treatment's success.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as being over 18 years old, having a diagnosis of persistent corneal epithelial defect, and providing informed consent.
A negative result for certain blood tests, including HIV and hepatitis, is required.
Step 2
Randomization and treatment assignment
Participants are randomly assigned to receive either insulin eye drops or standard treatment with autologous serum eye drops.
The study is observer-blinded, meaning the person assessing the outcomes does not know which treatment is being administered.
Step 3
Treatment administration
The treatment involves the use of insulin eye drops at a concentration of 1 IU/ml.
The frequency and duration of administration are determined by the study protocol and communicated to participants at the start of the trial.
Step 4
Monitoring and assessment
Participants are monitored for the closure of the epithelial defect, with assessments including the percentage of patients achieving complete re-epithelialization.
The rate of closure and time to complete closure are measured, with success defined as closure within the first two weeks or first month of treatment.
Step 5
Evaluation of secondary outcomes
Secondary outcomes include the percentage of patients with insufficient response or treatment failure.
Additional factors such as age, sex, and previous treatments are analyzed in relation to the response.
Step 6
Completion of the trial
The trial is expected to conclude by September 5, 2025.
Final assessments are conducted to determine the overall efficacy and safety of the treatment.

Who can join the trial?

4 criteria

Must be over 18 years old.
Must have a diagnosis of a persistent corneal epithelial defect, which means a long-lasting problem with the outer layer of the eye not healing properly.
Must sign an informed consent, which is a document that explains the study and confirms your agreement to participate.
Must have a negative result for certain blood tests, including HIV (Human Immunodeficiency Virus), HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), HLTV (Human T-Lymphotropic Virus), and syphilis, which are infections that can affect your health.

Who cannot join the trial?

7 criteria

Patients with any other eye condition that might interfere with the study results.
Patients who have had eye surgery in the last 3 months.
Patients using other eye medications that could affect the study.
Patients with allergies to any of the study medications.
Patients who are pregnant or breastfeeding.
Patients with uncontrolled diabetes or other serious health conditions.
Patients who are unable to follow the study procedures.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain
Hospital Universitario Puerta De Hierro De Majadahonda
Verified
Majadahonda, Spain

Trial locations

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Investigated drugs

Insulin Eye Drops
Insulin eye drops are being tested in this trial to see if they can help heal persistent corneal epithelial defects. These defects are areas on the surface of the eye that have not healed properly. The insulin in the eye drops is thought to promote healing by helping cells grow and repair the damaged area.
Autologous Serum Eye Drops
Autologous serum eye drops are made from a patient's own blood. They are used as a standard treatment for persistent corneal epithelial defects. These eye drops contain natural growth factors and nutrients that can help the eye heal by providing the necessary components for cell repair and regeneration.

Insulin Human

What is already known about the treatment

Insulin Eye Drops – This medication is administered as eye drops and is currently being studied in clinical trials for its effectiveness in treating persistent corneal epithelial defects. It is not yet widely recognized in medical literature as a standard treatment for this condition. The main therapeutic indication is for persistent corneal epithelial defects, particularly those of neurotrophic origin or due to chronic ocular surface diseases. At the molecular level, insulin is believed to promote healing by enhancing cellular growth and repair processes in the corneal tissue. It is classified pharmacologically as a growth factor.

Investigated diseases

Persistent Corneal Epithelial Defect – This condition involves a failure of the corneal epithelium, the outermost layer of the eye, to heal properly. It can occur due to various reasons, including nerve damage or chronic diseases affecting the eye's surface. The defect remains open, leading to discomfort and potential vision problems. Over time, the persistent defect can increase the risk of infection and further complications. The healing process is often slow and may require specialized treatments to encourage re-epithelialization. The condition is monitored by assessing the closure rate and time to complete healing.