A Phase 3 interventional study of Cenegermin and Vehicle in Persistent Corneal Epithelial Defect, sponsored by Dompé Farmaceutici S.p.A. Recruiting at 77 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Dompé Farmaceutici S.p.A · Phase 3, Interventional, and Treatment
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).
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's planned enrollment of 150 is above the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →Dompé Farmaceutici S.p.A is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 18 (100%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with PCED in the study eye with the following characteristics:
Exclusion Criteria:
Active ocular infection or inflammation in the study eye as follows:
Severe eyelid disease in the study eye, such as:
Severe end-stage ocular surface disease in the study eye, including but not limited to:
Use of the following medications and devices within the indicated time window prior to randomization:
a. Local medications in study eye:
Presence of acute severe systemic disease as follows:
Recent surgery or amniotic membrane therapy as follows:
Note: Additional exclusion criteria apply, as defined in the protocol
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomized to receive cenegermin ophthalmic solution in the study eye.
Drug: Cenegermin
Participants will be randomized to receive vehicle ophthalmic solution in the study eye.
Other: Vehicle
Cenegermin is administered topically.
Vehicle is administered topically.
Proportion of responders achieving complete epithelial healing of the cornea at Week 4 and maintained at Week 8
Time frame: At Weeks 4 and 8
Percentage change from baseline in maximum diameter of PCED at week 4
Time frame: Baseline and Week 4
Percentage change from baseline in maximum diameter of PCED at week 8
Time frame: Baseline and Week 8
Proportion of responders achieving complete epithelial healing of the cornea at Week 8 and maintained at Week 10
Time frame: At Weeks 8 and 10
Linear change from baseline in maximum diameter of the PCED at week 4
Time frame: Baseline and Week 4
Number of participants reporting Treatment Emergent Adverse Events (TEAEs)
Time frame: Through Week 40
Number of participants discontinuing the study due to intolerability
Time frame: Through Week 40
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Cenegermin