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Cenegermin Eye Drops for Persistent Corneal Epithelial Defect in Patients with Persistent Corneal Epithelial Defect

Fast replyRegistered 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 being done in people with Persistent Corneal Epithelial Defect (PCED), a condition in which the clear front surface of the eye does not heal properly. The study is testing cenegermin eye drops, given as an eye solution, and comparing them with a vehicle eye drop solution. Before the study eye drops are given, other eye drops such as oxybuprocaine hydrochloride, tetracaine hydrochloride, and tropicamide may be used as part of the eye care routine. The purpose of the study is to see whether cenegermin can help the eye surface heal better than the vehicle.

People in the study are assigned by chance to one of the eye drop groups. The study lasts for several weeks, and the eye is checked during treatment and again afterward to see whether healing has been maintained. The main focus is whether the damaged eye surface closes and stays healed over time.

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

    Study start and assignment

    After joining the study, you are placed into one of two groups in a random way. The assignment is randomized, which means it is decided by chance.

    The study is double-masked, which means you and the study team are not told which eye drops you receive.

    You receive either cenegermin eye drops or vehicle eye drops. vehicle means the eye-drop solution without the active medicine.

  2. Step 2

    Treatment period for 4 weeks

    You use the assigned eye drops for 4 weeks.

    If you receive cenegermin, the eye drop strength is 20 micrograms per millilitre and it is given by ocular use, which means it is placed in the eye.

    The study does not state the exact number of times per day or the exact dose for the cenegermin or vehicle eye drops.

    Before the eye drops are given, you receive 5 drops of COLIROFTA ANESTÉSICO DOBLE, which contains oxybuprocaine hydrochloride and tetracaine hydrochloride. This is a numbing eye drop used in the eye.

    You also receive 2 drops of tropicamide. Tropicamide is an eye drop used in the eye.

  3. Step 3

    Week 4 check

    At week 4, your eye condition is checked.

    The main check is whether the surface of the cornea has healed completely. The cornea is the clear front part of the eye.

    The study also measures the change in the largest size of the persistent corneal epithelial defect (PCED). A PCED is a wound or open area on the surface of the cornea that has not healed.

  4. Step 4

    Week 8 check

    At week 8, your eye condition is checked again.

    The study looks at whether complete healing is still present at this time.

    The study also measures the change in the largest size of the PCED from the start of the study.

  5. Step 5

    Week 10 check

    At week 10, another check is done if the study plan requires it for the healing assessment.

    The study looks for complete healing that is still maintained at this time.

Who can join the trial?

10 criteria

  • Be an adult, meaning 18 years of age or older.
  • Have persistent corneal epithelial defect (PCED) in the study eye, meaning a long-lasting open area on the clear front surface of the eye.
  • The PCED in the study eye must be at least 1.0 mm across at its widest point.
  • The PCED must have been present for at least 14 days.
  • The PCED must not have improved after one or more standard non-surgical treatments, such as:
    • Ocular lubricants (eye drops or ointments that keep the eye moist)
    • Stopping preserved drops and medications if they were irritating the eye
    • Bandage contact lens use, which is a soft contact lens used to protect the eye while it heals
    • Be able to use most other eye medicines for eye problems other than PCED in the study eye, as long as the dose has been stable for at least 30 days and is not expected to change during the study.
    • Be allowed to keep taking prophylactic antibiotics in the study eye, if already using them before joining the study. Prophylactic antibiotics are medicines taken to help prevent infection.
    • Be able and willing to sign the informed consent form, which means agreeing to take part in the study and following all study rules and requirements.

Who cannot join the trial?

30 criteria

  • Cannot join if the other eye has no light perception (it cannot see any light) or if the other eye is completely missing.
  • Cannot join if there is active substance abuse or dependence, including alcohol, illegal drugs, marijuana, or misuse of prescription medicines within 30 days before randomization (the time when a person is assigned to a study treatment).
  • Cannot join if there is known or suspected eye cancer, including cancer on the eye surface, inside the eye, or around the eye, or if there is cancer or another serious body-wide disease that may interfere with study participation, in the investigator’s opinion, including basal cell carcinoma of the head.
  • Cannot join if any eye or body disease could make the study treatment less likely to work, make it hard to measure the results, or make the study schedule difficult to follow, in the investigator’s opinion.
  • Cannot join while taking part in another investigational study (a research study testing an unapproved treatment).
  • Cannot join if there is a known or suspected allergy to cenegermin or to any ingredient in the study medicine, or if there is a known allergy to study test medicines or procedures such as fluorescein (a dye used in eye exams).
  • Cannot join if there is an active eye infection in the study eye, including bacterial, fungal, or protozoal infection at screening.
  • Cannot join if there are active infectious stromal infiltrates or edema in the study eye; stromal infiltrates are infection-related deposits in the cornea, and edema means swelling.
  • Cannot join if there is acute anterior uveitis grade 2 or higher within 30 days before screening; uveitis is inflammation inside the eye.
  • Cannot join if there is recent intermediate uveitis or posterior uveitis within 30 days before screening.
  • Cannot join if there is active inflammation of the sclera or conjunctiva that is not part of the PCED; the sclera is the white part of the eye, and the conjunctiva is the thin clear covering over it.
  • Cannot join if the corneal epithelial defect has stromal thinning greater than 30%, meaning the deeper support layer of the cornea is too thin, or if it has a stromal infiltrate; corneal haze is allowed.
  • Cannot join if there is severe eyelid disease in the study eye, including eyelash or lid problems that touch the defect, lagophthalmos greater than 2 mm (the eyelids cannot fully close), known nighttime lagophthalmos, Parkinson’s disease, inability to fully close the eyelids on purpose, or severe ectropion (the eyelid turns outward) with poor eyelid-to-eye contact.
  • Cannot join if there is severe end-stage eye surface disease in the study eye, including very severe limbal stem cell deficiency affecting more than 270 degrees of the limbus (the border area of the cornea), or keratinization of the conjunctiva or eyelid edge, meaning tissue becomes thick and hardened like skin.
  • Cannot join if there was any prior use of cenegermin in the study eye.
  • Cannot join if certain local eye treatments were used in the study eye within 7 days before randomization, including autologous serum (eye drops made from the patient’s own blood), other surface-healing eye treatments, anesthetic drops used outside the exam setting, insulin eye use, or steroids unless they were part of treatment after surgery.
  • Cannot join if Botox injections were used for temporary eyelid closure within 90 days before randomization.
  • Cannot join if high-dose corticosteroids were taken by mouth or another systemic route within 30 days before randomization; corticosteroids are anti-inflammatory medicines.
  • Cannot join if oral medicines meant to treat the eye surface, such as doxycycline, were started, stopped, or changed within 30 days before randomization, or if such changes are planned during the study.
  • Cannot join if systemic opioids were used within 30 days before randomization; opioids are strong pain medicines.
  • Cannot join if any systemic investigational product, an investigational eye product in the study eye, radiation to the head or neck, or systemic chemotherapy was used within 90 days before randomization, or is planned during the study.
  • Cannot join if a contact lens, including a therapeutic contact lens, was used in the study eye within 7 days before randomization or is planned during the study.
  • Cannot join if there is an expected need for punctal occlusion in the study eye during the study; punctal occlusion means blocking the tear drainage opening. A person can still join if punctal plugs or punctal occlusion were already placed before the study and stay in place throughout the study.
  • Cannot join if there is an active severe body-wide illness, such as acute Stevens-Johnson syndrome, active graft-versus-host disease, severe Sjögren’s disease, or mucous membrane pemphigoid.
  • Cannot join if there is any body-wide disease that may affect the ability to take part in the study, according to the investigator’s judgment.
  • Cannot join if there was a recent major surgery for the eye defect within 14 days before randomization, such as a conjunctival flap, complete tarsorrhaphy (full eyelid closure by surgery), or superficial keratectomy for epithelial defect revision.
  • Cannot join if amniotic membrane therapy is still present in the area of the eye defect within 14 days before randomization, including sutured amniotic membrane, self-retaining amniotic membrane, contact lens with amniotic membrane, or other amniotic membrane treatment for the eye surface unless it has dissolved within the defect area.
  • Cannot join if partial tarsorrhaphy was placed within 14 days before randomization; partial tarsorrhaphy means partly sewing the eyelids together. If it was placed more than 14 days earlier, it must stay in place for the whole study.
  • Cannot join if a female who can become pregnant is known to be pregnant, has a positive pregnancy test, plans to become pregnant during the study, is breastfeeding, or is unwilling to use acceptable contraception until 30 days after study treatment ends.
  • Cannot join if a fertile male participant is unwilling to use acceptable contraception (a male condom with spermicidal cream or jelly) until 30 days after study treatment ends.
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Investigated drugs

  • Oxervate

    is an eye drop treatment that contains cenegermin, a man-made form of nerve growth factor. In this trial, it is the main study medicine being tested to help heal a persistent corneal epithelial defect, which is a wound on the surface of the eye that has not healed properly.

  • Colirofta anestésico doble

    is a numbing eye drop used before eye examinations or procedures. It contains two local anesthetics, oxybuprocaine hydrochloride and tetracaine hydrochloride, which help reduce pain and discomfort in the eye.

  • Tropicamide

    is an eye drop used to widen the pupil. This helps the study team examine the eye more clearly during the trial and monitor how the cornea is healing.

What is already known about the treatment

  • Cenegermin

    Cenegermin is supplied as eye drops and is placed directly into the eye, usually several times a day as directed in the study. It is an approved medicine in modern eye care and is well described in medical literature for treating persistent corneal epithelial defect and other problems where the clear front part of the eye does not heal well. It works like a natural human nerve growth factor, helping eye surface cells survive, grow, and repair themselves, and it is classified as a nerve growth factor-based eye medicine.

  • Oxybuprocaine hydrochloride and tetracaine hydrochloride

    This medicine is given as eye drops and applied directly to the eye to numb the surface before examination or a procedure. Both substances are well known local anesthetics in medicine and are commonly used in eye care to quickly reduce pain and discomfort. They work by blocking nerve signals in the eye surface, so pain messages cannot travel as easily, and they are classified as local anesthetic eye drops.

  • Tropicamide

    Tropicamide is given as eye drops and is placed directly into the eye, often before an eye examination to widen the pupil. It is a long-established medicine in eye care and is widely used in medical practice and literature. It works by blocking the action of acetylcholine in the eye, which relaxes the pupil muscles and makes the pupil larger, and it is classified as an antimuscarinic eye medicine.

Investigated diseases

Persistent Corneal Epithelial Defect - A persistent corneal epithelial defect is a condition in which the clear outer surface of the eye does not heal properly after an injury or irritation. The surface layer of the cornea remains open instead of closing as expected, often forming a lasting defect. It may stay the same for a time or slowly enlarge if healing does not occur.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523443-35-00Protocol codeNGF-PCED-301Estimated enrolment215 patientsSponsorDompe' Farmaceutici S.p.A.

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