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Study on the Safety and Effectiveness of Lufepirsen Gel for Patients with Persistent Corneal Epithelial Defects

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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 Defects. This condition affects the clear, outer layer of the eye, known as the cornea, and involves a defect or wound that does not heal properly. The trial will evaluate a treatment called NEXAGON, which is an ophthalmic gel containing the active ingredient lufepirsen. The purpose of the study is to assess the safety and effectiveness of NEXAGON in helping the cornea heal and maintain its healing for at least 28 days.

Participants in the study will be randomly assigned to receive either the NEXAGON gel or a similar gel that does not contain the active ingredient, known as a placebo. The study will be conducted over a period of time, during which participants will apply the gel to their eyes as directed. Throughout the study, the healing of the corneal defect will be monitored using special imaging techniques to ensure accurate assessment.

The trial aims to determine if NEXAGON can successfully promote the healing of the corneal defect and maintain this healing over time. Participants will be closely monitored for any side effects or changes in their condition. The study will provide valuable information on the potential benefits of NEXAGON for individuals with persistent corneal epithelial defects.

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, the participant will be randomly assigned to receive either the NEXAGON ophthalmic gel or a vehicle gel without the active ingredient.

    The participant will be informed about the study procedures and will provide written consent to participate.

  2. Step 2

    Treatment period

    The participant will apply the assigned gel topically to the affected eye. The frequency and duration of application will be determined by the study protocol.

    The goal is to achieve corneal re-epithelialization, which means the healing of the corneal surface, and maintain it for at least 28 days.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the participant will attend regular visits for monitoring and assessments.

    These assessments include checking vital signs, conducting eye examinations, and evaluating any side effects or changes in vision.

  4. Step 4

    End of treatment

    At the end of the treatment period, the participant will undergo a final assessment to evaluate the effectiveness of the treatment.

    The study will measure the proportion of participants who achieve and maintain corneal healing for at least 28 days.

  5. Step 5

    Follow-up

    After completing the treatment, the participant may be required to attend follow-up visits to monitor the long-term effects of the treatment.

    These visits will help ensure the safety and continued health of the participant's eyes.

Who can join the trial?

8 criteria

  • Participants can be either male or female.
  • Participants must be at least 2 years old in the US, and at least 18 years old in other countries.
  • Participants must have a **corneal epithelial defect** that has lasted at least 2 weeks and has not improved with standard non-surgical treatments. A **corneal epithelial defect** is a problem with the surface layer of the eye.
  • There should be no signs of improvement in the corneal epithelial defect within 2 weeks before joining the study, even with non-surgical treatments.
  • The defect in the eye's surface must measure at least 2 millimeters in size at the start of the treatment period.
  • Participants or their legal representatives must be able to give written consent before taking part in any study-related activities.
  • Female participants who can have children must be either 1-year postmenopausal, surgically sterilized, or have a negative pregnancy test at the first two visits. They must also use an acceptable form of birth control during the study. Acceptable methods include abstinence, hormonal contraception (like pills or patches), implants, injections, vaginal rings, intrauterine devices (IUDs), condoms with spermicides, diaphragms with spermicides, or having a sterile partner.
  • Participants must be able and willing to follow all study procedures.

Who cannot join the trial?

3 criteria

  • Individuals who do not have persistent corneal epithelial defects. This means the outer layer of the eye's surface is not healing properly.
  • Individuals who are not within the specified age range for the study.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

NEXAGON is an ophthalmic gel being studied for its ability to help heal persistent corneal epithelial defects. It is applied to the eye to promote the re-epithelialization of the cornea, which means it helps the surface of the eye heal and regenerate. The study aims to determine if NEXAGON is safe and effective in maintaining corneal healing for at least 28 days.

What is already known about the treatment

Lufepirsen Ophthalmic Gel – This medication is administered as an eye gel and is currently being studied in clinical trials for its safety and effectiveness in treating persistent corneal epithelial defects. It is in the phase 2 stage of clinical trials, indicating that it is still under investigation and not yet widely available for general medical use. The main therapeutic indication for Lufepirsen is to promote corneal re-epithelialization, which is the healing of the corneal surface. At the molecular level, it is believed to work by modulating cellular processes that aid in the repair and regeneration of the corneal epithelium. Lufepirsen is classified pharmacologically as an ophthalmic agent, specifically designed to address issues related to the cornea.

Investigated diseases

Persistent Corneal Epithelial Defects – This condition involves the failure of the corneal epithelium, the outermost layer of the eye, to heal properly after an injury or surgery. Normally, the corneal epithelium regenerates quickly, but in this condition, the healing process is delayed or incomplete. This can lead to discomfort, vision problems, and an increased risk of infection. The defect may persist due to underlying issues such as dry eye, inflammation, or inadequate tear production. Over time, the persistent defect can cause scarring or further damage to the cornea. The condition requires careful management to promote healing and prevent complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507030-24-00Protocol codeGLK-601-01AMB-01-006Estimated enrolment144 patientsSponsorGlaukos Corp.

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