Eye drop breakthrough: nerve growth factor heals corneal wounds in phase 3 trial

NCT ID NCT07519902

Cure Sponsor: Dompé Farmaceutici S.p.A Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tests an eye drop containing a human nerve growth factor to help heal persistent corneal defects (wounds on the eye's surface that won't close). About 150 adults with such wounds will receive either the active drop or a placebo. The goal is to see if the drop can fully heal the cornea within 4 weeks and keep it healed.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men or women aged 18 years or above (in South Korea, 19 years or above). * Participants with PCED in the study eye with the following characteristics: 1. PCED ≥ 1.0 mm in greatest diameter 2. PCED of at least 14 days duration, refractory to 1 or more conventional nonsurgical treatments (ocular lubricants, discontinuation of preserved topical drops and medications, bandage contact lens) showing no clinical resolution. * Use of most topical ophthalmic medications (including glaucoma medications) indicated for ocular conditions other than PCED is permitted in the study eye, if the participant has been on a stable dose for at least 30 days and does not expect to have change in dosing regimen throughout the entire duration of the study. Please see exclusion criteria list for exceptions. * Use of prophylactic topical antibiotics up to 4 times per day in the study eye is permitted if the participant is already receiving them prior to enrollment. Exclusion Criteria: * Contralateral eye with vision of no light perception or anatomic absence of contralateral eye. * Active ocular infection or inflammation in the study eye as follows: 1. Bacterial, fungal, or protozoal infection at screening 2. Active infectious stromal infiltrates or edema at screening 3. Acute anterior uveitis of grade 2 or greater within 30 days of screening 4. Acute intermediate uveitis or posterior uveitis within 30 days of screening 5. Acute inflammation of the sclera or conjunctiva if it is not associated with the PCED * Corneal epithelial defect associated with stromal thinning greater than 30% (estimated on clinical slit lamp exam) or if associated with stromal infiltrate (corneal haze is acceptable), in the study eye. * Severe eyelid disease in the study eye, such as: 1. Mechanical eyelid abnormalities that have direct contact with the PCED (e.g., trichiasis, severe entropion with lid margin keratinization, etc, if in direct contact with the PCED) 2. Lagophthalmos greater than 2 mm as measured in the clinic 3. Existing diagnosis of nocturnal lagophthalmos or Parkinson's disease 4. Inability to fully close eyelids despite voluntary eyelid closure 5. Severe ectropion with abnormal eyelid-globe congruity (e.g., the lower eyelid does not come into contact with the globe due to severe ectropion) * Severe end-stage ocular surface disease in the study eye, including but not limited to: 1. Severe limbal stem cell deficiency, defined as involvement of more than 270 cumulative degrees or more of limbal stem cell deficiency 2. Keratinization of the bulbar conjunctiva or lid margin * Use of the following medications and devices within the indicated time window prior to randomization: a. Local medications in study eye: * Any prior use of cenegermin * Blood-derived eye drops (autologous serum) or other ocular surface re-epithelizing agents, topical anesthetic use by the participant outside of the clinical exam setting, topical insulin, or topical steroids (unless associated with post-operative treatment regimen) within 7 days * Botox (botulinum toxin) injections for pharmacologic tarsorrhaphy within 90 days b. Systemic medications: * High-dose systemic corticosteroids (greater than 0.5 mg/kg/day) within 30 days * Any changes in oral medication regimen intended for the treatment of the ocular surface (eg, oral doxycycline) within 30 days, or planned changes during the study period * Systemic opioid use within 30 days * Use of any systemic investigational product, ocular investigational product in the study eye, radiation of the head or neck, or systemic chemotherapy within 90 days, or planned to occur during the study period c. Devices: * Use of contact lens (including therapeutic contact lens) within 7 days, or planned use of contact lens during the study period, in the study eye * Anticipated need for punctal occlusion in the study eye during the study period. Participants with punctal occlusion or punctal plugs inserted prior to the study are eligible for enrolment provided that the punctual occlusion is maintained throughout the study. * Presence of acute severe systemic disease as follows: 1. Any acute or active severe systemic inflammatory disease (eg, acute systemic Stevens-Johnson Syndrome, acute systemic GVHD, severe systemic Sjogren's, mucous membrane pemphigoid) 2. Presence of any systemic disease that may affect ability to participate in the clinical study according to the clinical judgment of the investigator * Recent surgery or amniotic membrane therapy as follows: 1. Recent major surgical procedure for the treatment of PCED (eg, conjunctival flap, complete tarsorrhaphy, superficial keratectomy for epithelial defect revision, etc) within 14 days of randomization 2. Presence of amniotic membrane from AMT for ocular surface indication if not dissolved within area of PCED within 14 days of randomization. Examples include: * Sutured AMT * Self-retaining AMT * Contact lens combined with AMT * Other AMT treatment for the ocular surface c. Partial tarsorrhaphy (temporary or permanent) placed within 14 days of randomization. If a participant is enrolled with partial tarsorrhaphy placed more than 14 days prior to randomization, then the tarsorrhaphy must not be removed for the entire duration of the study. Note: Additional exclusion criteria apply, as defined in the protocol

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Conditions

The condition(s) this trial relates to.

Conjunctivitis, Allergic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Persistent corneal epithelial defect

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

77 sites in 14 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

APHP Hopital Cochin
NOT_YET_RECRUITING

Paris, 75014, France
ASST Fatebenefratelli Sacco - Oculistica Sacco
NOT_YET_RECRUITING

Milan, 20157, Italy
Amsterdam UMC - Ophthalmology
NOT_YET_RECRUITING

Amsterdam, North Holland, 1081 HZ, Netherlands
Asan Medical Center - Asan Cancer Center
NOT_YET_RECRUITING

Seoul, 5505, South Korea
Asociacion para Evitar la Ceguera en Mexico
NOT_YET_RECRUITING

Mexico City, Mexico City, 4030, Mexico
Azienda Ospedaliero Universitaria Careggi - Oculistica
NOT_YET_RECRUITING

Florence, 50134, Italy
Azul Vision, INC
RECRUITING

Huntington Beach, California, 92647, United States
Bascom Palmer Eye Institute, University of Miami School of Medicine
RECRUITING

Miami, Florida, 33136, United States
Buenos Aires Macula S.A. - Clinic
NOT_YET_RECRUITING

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1061AAE, Argentina
CHU Saint Etienne, Hôpital Nord
NOT_YET_RECRUITING

Saint-Etienne, Auvergne-Rhône-Alpes, 42702, France
California Eye Specialists Medical Group, Inc.
RECRUITING

Redlands, California, 92373, United States
Centre Hospitalier Regional Universitaire (CHRU) Brest
NOT_YET_RECRUITING

Brest, Brittany Region, 29200, France
Centre Hospitalier Régional Universitaire de Tours
NOT_YET_RECRUITING

Tours, Indre-et-Loire, 37000, France
Centro Oftalmologico Dr Charles SA
NOT_YET_RECRUITING

Buenos Aires, Buenos Aires F.D., C1121, Argentina
Centro Oftalmologico de Tijuana, S.A de C.V.
NOT_YET_RECRUITING

Col. Buenos Aires NorteTijuana, Estado de Baja California, 22330, Mexico
Centro de Ojos de la Coruna
RECRUITING

A Coruña, A Coruna, 15006, Spain
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
NOT_YET_RECRUITING

Berlin, 13353, Germany
Chonnam National University Hospital - Ophthalmology
NOT_YET_RECRUITING

Gwangju, Gwangju Gwang'Yeogsi [Kwangju-Kwangyokshi], 61469, South Korea
Departamento de Oftalmologia, Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
NOT_YET_RECRUITING

Monterrey, Nuevo León, 64460, Mexico
Duke Eye Center - Ophthalmology
NOT_YET_RECRUITING

Durham, North Carolina, 27705, United States
East Coast Institute for Research - Florida Eye Specialists
RECRUITING

Jacksonville, Florida, 32207, United States
Ehime University Hospital
NOT_YET_RECRUITING

Tōon, Ehime, 791-0295, Japan
FN Brno - Ocni klinika
NOT_YET_RECRUITING

Brno, Brno-město, 625 00, Czechia
Fondation Ophtalmologique A. de Rothschild
NOT_YET_RECRUITING

Paris, 75019, France
Fondazione G.B. Bietti Per Lo Studio E La Ricerca In Oftalmologia - Unita' Segmento Anteriore
NOT_YET_RECRUITING

Roma, 184, Italy
Fondazione IRCCS Policlinico San Matteo - Oculistica
NOT_YET_RECRUITING

Pavia, 27100, Italy
Fundacion Zambrano
NOT_YET_RECRUITING

Buenos Aires, Buenos Aires F.D., C1023AAQ, Argentina
Fundación de Oftalmología Médica de la Comunitat Valenciana
RECRUITING

Valencia, 46015, Spain
Gabinet Okulistyczny Prof Edward Wylegala
RECRUITING

Katowice, Silesian Voivodeship, 40-594, Poland
Harvard Eye Associates
RECRUITING

Laguna Hills, California, 92653, United States
Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf (UKD)
NOT_YET_RECRUITING

Düsseldorf, North Rhine-Westphalia, 40225, Germany
Hospital Italiano de Buenos Aires
NOT_YET_RECRUITING

Ciudad Autonoma de Buenos Aire, Buenos Aires, C1199ABB, Argentina
Hospital La Arruzafa - Instituto de OftalmologÃ-a La Arruzafa
RECRUITING

Cardona, Andalusia, 14012, Spain
Hospital Regional Universitario de Malaga
NOT_YET_RECRUITING

Málaga, 29010, Spain
Hospital Universitari Germans Trias i Pujol (HUGTP)
RECRUITING

Badalona, Barcelona, 8916, Spain
Hospital Universitario Austral
NOT_YET_RECRUITING

Pilar, Buenos Aires, B1629ODT, Argentina
Houston Eye Associates (HEA)
RECRUITING

Houston, Texas, 77030, United States
I. Microcirugía Ocular - IMO - Oftalmología
RECRUITING

Barcelona, 8035, Spain
IOBA Instituto de Oftalmología Biologica Aplicada
RECRUITING

Valladolid, 47011, Spain
Instituto de Oftalmologia ''Fundacion de Asistencia Privada Conde de Valenciana IAP - Ophthalmology
NOT_YET_RECRUITING

Mexico, Puebla, 6080, Mexico
Johann Wolfgang Goethe-Universitaet Frankfurt - Klinik fuer Augenheilkunde
NOT_YET_RECRUITING

Frankfurt am Main, Hesse, 60596, Germany
Kliniken der Stadt Koeln
NOT_YET_RECRUITING

Cologne, North Rhine-Westphalia, 51109, Germany
Korea University Anam Hospital
NOT_YET_RECRUITING

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 2841, South Korea
Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
RECRUITING

Liverpool, England, L78XP, United Kingdom
Loma Linda University Adventist Health Sciences Center
NOT_YET_RECRUITING

Loma Linda, California, 92354, United States
Massachusetts Eye and Ear
RECRUITING

Boston, Massachusetts, 02114, United States
Midwest Vision Research Foundation
RECRUITING

Chesterfield, Missouri, 63017, United States
Moorfields eye Hospital
RECRUITING

London, York, EC1V 2PD, United Kingdom
NYU Langone Eye Center (Ophthalmology)
NOT_YET_RECRUITING

New York, New York, 10017, United States
Nottingham University Hospitals NHS Trust - Queen's Medical Centre
NOT_YET_RECRUITING

Nottingham, NG7 2UH, United Kingdom
OCHO Lublin Gabinety Okulistyczne
RECRUITING

Lublin, Lublin Voivodeship, 20-704, Poland
Oculistica
NOT_YET_RECRUITING

Milan, 20132, Italy
Oftar S.R.L.
NOT_YET_RECRUITING

Mendoza, M5500, Argentina
Ophthalmic Consultants of Boston
RECRUITING

Boston, Massachusetts, 02114, United States
Ospedale Santa Maria della Misericordia - Oculistica
NOT_YET_RECRUITING

Perugia, S. Andrea Delle Fratte, Perugia, 6129, Italy
Philipps-University Marburg
NOT_YET_RECRUITING

Marburg, Hesse, 35043, Germany
Samodzielny Publiczny Kliniczny Szpital Okulistyczny
RECRUITING

Warsaw, Masovian Voivodeship, 03-709, Poland
Semmelweis Egyetem - Ophthalmology
NOT_YET_RECRUITING

Budapest, H-1089, Hungary
Soon Chun Hyang University Hospital Seoul
NOT_YET_RECRUITING

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 4401, South Korea
The Catholic University of Korea, Bucheon St.Mary's Hospital
NOT_YET_RECRUITING

Bucheon-si, Gyeonggido [Kyonggi-do], 14647, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital - Ophthalmology
NOT_YET_RECRUITING

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6591, South Korea
The Eye Institute of Utah
RECRUITING

Salt Lake City, Utah, 84107, United States
The Rotterdam Eye Hospital - unspecified
NOT_YET_RECRUITING

Rotterdam, South Holland, 3011 BH, Netherlands
The University of Tokyo Hospital
NOT_YET_RECRUITING

Bunkyō City, Tôkyô [Tokyo], 113-8655, Japan
UCLA - Jules Stein Eye Institute (JSEI) - Diabetic Eye Dise
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
Universitaetsklinikum Erlangen - Augenklinik
NOT_YET_RECRUITING

Erlangen, Bavaria, 91054, Germany
Universitaetsklinikum Koeln - Zentrum fuer Augenheilkunde
NOT_YET_RECRUITING

Cologne, North Rhine-Westphalia, 50937, Germany
Universitaetsklinikum des Saarlandes - Augenklinik
NOT_YET_RECRUITING

Homburg, Saarland, 66421, Germany
Universitair Medisch Centrum Utrecht - Ophthalmology
NOT_YET_RECRUITING

Utrecht, 3584 CX, Netherlands
University Hospitals Bristol and Weston NHS Foundation Trust - Bristol Eye Hospital
RECRUITING

Bristol, Bristol, City of, BS1 2LX, United Kingdom
University of Michigan Health - Kellogg Eye Center
NOT_YET_RECRUITING

Ann Arbor, Michigan, 48105, United States
University of South Florida
RECRUITING

Tampa, Florida, 33620, United States
Vance Thompson Vision - Sioux Falls
RECRUITING

Sioux Falls, South Dakota, 57108, United States
Vididit Kft.
NOT_YET_RECRUITING

Eger, Heves County, 3300, Hungary
Virginia Eye Consultants
RECRUITING

Norfolk, Virginia, 23502, United States
Vseobecna fakultni nemocnice v Praze - Ocni klinika
NOT_YET_RECRUITING

Prague, Praha, Hlavní Mesto, 128 08, Czechia
Yonsei University Wonju Severance Christian Hospital
NOT_YET_RECRUITING

Wŏnju, Gang'weondo [Kang-won-do], 26426, South Korea

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