An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treat… (NCT07519902) | Clinical Trial Compass
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
United States150 participantsStarted 2026-06-02
Plain-language summary
This is a phase 3, randomized, multicenter, double-masked, parallel group, vehicle-controlled prospective clinical trial to evaluate the safety and efficacy of cenegermin in inducing complete epithelial healing in participants with PCED. The primary objective is the evaluation of complete epithelial healing after 4 weeks of treatment. The study is comprised of 3 periods: an 8-week initial treatment period (Day 1 to Week 8), an 8-week extension treatment period (Week 9 to Week 16), and a 24-week follow-up period (Week 17 to Week 40).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. PCED ≥ 1.0 mm in greatest diameter
. 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.
Exclusion criteria
. Bacterial, fungal, or protozoal infection at screening
. Active infectious stromal infiltrates or edema at screening
. Acute anterior uveitis of grade 2 or greater within 30 days of screening
. Acute intermediate uveitis or posterior uveitis within 30 days of screening
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of responders achieving complete epithelial healing of the cornea at Week 4 and maintained at Week 8
Timeframe: At Weeks 4 and 8
Trial details
NCT IDNCT07519902
SponsorDompé Farmaceutici S.p.A
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-12
Contact for this trial
Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)
. Acute inflammation of the sclera or conjunctiva if it is not associated with the PCED
. 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)
. Lagophthalmos greater than 2 mm as measured in the clinic
. Existing diagnosis of nocturnal lagophthalmos or Parkinson's disease