Actively Recruiting
Phase 3, Randomized, Double-Masked Study of Cenegermin Eye Drops Compared With Vehicle for Persistent Corneal Epithelial Defect
Led by Dompé Farmaceutici S.p.A · Updated on 2026-06-05
150
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of cenegermin ophthalmic solution compared with a vehicle solution in treating Persistent Corneal Epithelial Defect (PCED). This phase 3, randomized, double-masked, vehicle-controlled study aims to determine whether cenegermin can induce complete healing of the corneal epithelium after 4 weeks of treatment. The trial is sponsored by Dompé Farmaceutici S.p.A and involves multiple centers. Participants will be randomly assigned to receive either the active drug cenegermin or a vehicle solution applied topically to the affected eye. The study includes three main periods: an 8-week initial treatment phase, followed by an 8-week extension treatment phase, and then a 24-week follow-up phase to monitor ongoing effects and safety. Throughout the study, participants will undergo assessments to measure the healing of the corneal epithelium, including the proportion achieving complete healing at weeks 4 and 8. Researchers will also track changes in the size of the epithelial defect and record any adverse events or reasons for discontinuation. The total study duration for each participant is 40 weeks, with regular evaluations during treatment and follow-up periods.
CONDITIONS
Brief Title
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 18 years or above (19 years or above in South Korea)
- Persistent Corneal Epithelial Defect (PCED) in the study eye with a diameter of at least 1.0 mm
- PCED lasting at least 14 days and not responding to one or more conventional nonsurgical treatments
- Stable use of most topical ophthalmic medications for at least 30 days prior to the study with no expected dose changes
- Use of prophylactic topical antibiotics up to 4 times per day if already being used before enrollment
You will not qualify if you...
- Vision of no light perception or absence of the opposite eye
- Active eye infection or inflammation such as bacterial, fungal, or protozoal infection, infectious stromal infiltrates, or acute uveitis within 30 days
- Corneal epithelial defect with stromal thinning greater than 30% or associated stromal infiltrate
- Severe eyelid diseases including mechanical abnormalities contacting the defect, lagophthalmos greater than 2 mm, nocturnal lagophthalmos, Parkinson's disease, or inability to fully close eyelids
- Severe end-stage ocular surface disease, including severe limbal stem cell deficiency or keratinization of conjunctiva or lid margin
- Use of specific medications or devices within defined time windows prior to randomization, including prior cenegermin use, blood-derived eye drops, topical anesthetics outside exams, botox injections, systemic corticosteroids, systemic opioids, investigational products, chemotherapy, or contact lenses
- Anticipated need for punctal occlusion during the study period
- Severe systemic diseases affecting participation
- Recent major eye surgery or amniotic membrane therapy within 14 days
- Partial tarsorrhaphy placed within 14 days unless maintained during the study period
- Additional exclusion criteria as defined in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants receive either cenegermin ophthalmic solution or vehicle ophthalmic solution administered topically to the study eye.
Visits at baseline, Week 4, and Week 8 for assessments
Trial Site Locations
Total: 18 locations
1
Azul Vision, INC
Huntington Beach, California, United States, 92647
Not Yet Recruiting
2
Harvard Eye Associates
Laguna Hills, California, United States, 92653
Actively Recruiting
3
Loma Linda University Adventist Health Sciences Center
Loma Linda, California, United States, 92354
Not Yet Recruiting
4
UCLA - Jules Stein Eye Institute (JSEI) - Diabetic Eye Dise
Los Angeles, California, United States, 90095
Not Yet Recruiting
5
California Eye Specialists Medical Group, Inc.
Redlands, California, United States, 92373
Not Yet Recruiting
6
East Coast Institute for Research - Florida Eye Specialists
Jacksonville, Florida, United States, 32207
Actively Recruiting
7
Bascom Palmer Eye Institute, University of Miami School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
8
University of South Florida
Tampa, Florida, United States, 33620
Actively Recruiting
9
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
10
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
University of Michigan Health - Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
Not Yet Recruiting
12
Midwest Vision Research Foundation
Chesterfield, Missouri, United States, 63017
Actively Recruiting
13
NYU Langone Eye Center (Ophthalmology)
New York, New York, United States, 10017
Not Yet Recruiting
14
Duke Eye Center - Ophthalmology
Durham, North Carolina, United States, 27705
Not Yet Recruiting
15
Vance Thompson Vision - Sioux Falls
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
16
Houston Eye Associates (HEA)
Houston, Texas, United States, 77030
Actively Recruiting
17
The Eye Institute of Utah
Salt Lake City, Utah, United States, 84107
Actively Recruiting
18
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Actively Recruiting
Research Team
D
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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