Ongoing Clinical Trials for Persistent Corneal Epithelial Defect
There are currently 2 clinical trials investigating new treatments for persistent corneal epithelial defect, a condition where the outer layer of the eye does not heal properly. These trials are being conducted in Spain, Germany, and Italy, and are testing innovative treatments including insulin eye drops and a new gel containing lufepirsen to help promote healing of the corneal surface.
Clinical trial locations
- Germany
- Italy
- Spain
Study on Insulin Eye Drops for Treating Persistent Corneal Epithelial Defect in Patients with Neurotrophic or Chronic Ocular Surface Diseases
This trial is testing whether insulin eye drops can help heal the corneal surface in patients whose eye defects are caused by nerve damage or long-term eye surface diseases. The study compares insulin eye drops with autologous serum eye drops, which are made from a patient’s own blood and represent the current standard treatment.
Main inclusion criteria: Participants must be over 18 years old and have a diagnosis of persistent corneal epithelial defect. They must sign an informed consent form and have negative results for certain blood tests, including HIV, Hepatitis C, Hepatitis B, Human T-Lymphotropic Virus, and syphilis.
Main exclusion criteria: The study cannot include patients with other eye conditions that might interfere with results, those who have had eye surgery in the last 3 months, those using other eye medications that could affect the study, or those with allergies to study medications. Pregnant or breastfeeding women, patients with uncontrolled diabetes or other serious health conditions, and those unable to follow study procedures are also excluded.
Trial focus: The study aims to determine how quickly healing occurs and whether insulin eye drops are as effective or more effective than the current standard treatment. Researchers will monitor the healing process to see if the corneal defect closes completely, with success defined as closure within the first two weeks or first month of treatment. The trial is expected to conclude by September 5, 2025.
Investigational drugs: The trial tests insulin eye drops at a concentration of 1 IU/ml, which are thought to promote healing by helping cells grow and repair the damaged area. These are compared with autologous serum eye drops, which are made from a patient’s own blood and contain natural growth factors and nutrients that help the eye heal.
Study on the Safety and Effectiveness of Lufepirsen Gel for Patients with Persistent Corneal Epithelial Defects
This trial evaluates a treatment called NEXAGON, an ophthalmic gel containing lufepirsen. The study aims to assess whether NEXAGON can help the cornea heal and maintain this healing for at least 28 days. Participants will be randomly assigned to receive either the NEXAGON gel or a placebo gel that does not contain the active ingredient.
Main inclusion criteria: Participants can be male or female and must be at least 2 years old in the US or at least 18 years old in other countries. They must have a corneal epithelial defect that has lasted at least 2 weeks without improvement despite standard non-surgical treatments. The defect must measure at least 2 millimeters in size at the start of treatment. Female participants who can have children must use acceptable birth control methods and have a negative pregnancy test. All participants or their legal representatives must provide written consent and be willing to follow all study procedures.
Main exclusion criteria: The study excludes individuals who do not have persistent corneal epithelial defects, those outside the specified age range, and individuals who are part of a vulnerable population that might need special protection or care.
Trial focus: The study will monitor corneal healing using special imaging techniques throughout the treatment period. Regular visits will be conducted to check vital signs, perform eye examinations, and evaluate any side effects or changes in vision. The primary goal is to determine the proportion of participants who achieve and maintain corneal healing for at least 28 days.
Investigational drug: NEXAGON is an ophthalmic gel containing lufepirsen that is applied to the eye to promote re-epithelialization of the cornea, helping the surface of the eye heal and regenerate. Lufepirsen is believed to work by modulating cellular processes that aid in the repair and regeneration of the corneal epithelium. This medication is currently in phase 2 clinical trials, meaning it is still under investigation and not yet widely available for general medical use.
Summary
Both ongoing trials for persistent corneal epithelial defect are exploring innovative approaches to healing the corneal surface. One trial focuses on repurposing insulin, a well-known diabetes medication, as eye drops to promote corneal healing, particularly in cases involving nerve damage or chronic eye surface diseases. The other trial is investigating NEXAGON, a newer experimental gel containing lufepirsen that works at the cellular level to support tissue repair and regeneration.
Geographically, Spain is participating in both trials, while Germany and Italy are involved in the lufepirsen study. Both studies share a common goal of determining whether these new treatments can successfully promote and maintain corneal healing, offering potential alternatives to current standard treatments. The trials employ rigorous monitoring protocols to assess safety and effectiveness, which will provide valuable information for future treatment options for this challenging condition.
