What is cenegermin studying for Persistent Corneal Epithelial Defect (PCED)?

Cenegermin is being studied to see if it can safely help heal the corneal surface in people with PCED. This trial compares cenegermin eye drops to a placebo to evaluate complete healing after 4 weeks. The study is sponsored by Dompé Farmaceutici S.p.A and involves multiple research centers.

Who may be eligible for this Persistent Corneal Epithelial Defect (PCED) clinical trial?

Adults aged 18 years or older with PCED lasting at least 14 days that has not improved with standard treatments may be eligible. Both men and women can participate. People with active eye infections, recent eye surgeries, or planned contact lens use in the study eye may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this Persistent Corneal Epithelial Defect (PCED) clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal expenses such as travel to the study site may vary and are not guaranteed to be covered. Participants should plan accordingly for such costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID07519902

Phase 3 Study to Evaluate Safety and Effectiveness of Cenegermin Eye Drops Compared to Placebo in Adults with Persistent Corneal Epithelial Defect

Led by Dompé Farmaceutici S.p.A · Updated on 2026-07-16

150

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are conducting a phase 3, randomized, double-masked clinical trial to evaluate the safety and effectiveness of cenegermin ophthalmic solution compared with a vehicle solution in treating Persistent Corneal Epithelial Defect PCED. The main goal is to assess whether cenegermin can induce complete healing of the corneal epithelium after 4 weeks of treatment. This multicenter study involves participants with PCED that has not improved with conventional nonsurgical treatments. Participants will be randomly assigned to receive either cenegermin or a matching vehicle solution applied topically to the affected eye. The study includes three periods an initial 8-week treatment phase Day 1 to Week 8, an 8-week extension treatment phase Week 9 to Week 16, and a 24-week follow-up phase Week 17 to Week 40. The dosing schedule and administration details are aligned with these periods to monitor healing and safety outcomes. Throughout the trial, participants will undergo regular assessments including measurements of the corneal defect size and evaluations of complete epithelial healing at specified weeks. Researchers will also monitor for any treatment-emergent adverse events and participants who discontinue due to intolerability. The total participation duration can last up to 40 weeks, covering treatment and follow-up to evaluate sustained healing and safety.

CONDITIONS

Brief Title

An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Men or women aged 18 years or older (19 years or older in South Korea)
Diagnosis of Persistent Corneal Epithelial Defect (PCED) in the study eye with greatest diameter of 1.0 mm or more
PCED lasting at least 14 days and not improving with one or more conventional nonsurgical treatments
Stable use of topical ophthalmic medications for other eye conditions for at least 30 days
Use of prophylactic topical antibiotics up to 4 times daily if already receiving prior to enrollment

You will not qualify if you...

Contralateral eye with no light perception or absence of the eye
Active bacterial, fungal, or protozoal infection in the study eye
Active infectious stromal infiltrates or edema in the study eye
Acute anterior uveitis grade 2 or greater within 30 days
Acute intermediate or posterior uveitis within 30 days
Acute inflammation of sclera or conjunctiva unrelated to PCED
Corneal epithelial defect with stromal thinning over 30% or associated stromal infiltrate
Severe eyelid diseases affecting the study eye, including mechanical abnormalities, lagophthalmos over 2 mm, nocturnal lagophthalmos, Parkinson's disease, inability to fully close eyelids, or severe ectropion
Severe end-stage ocular surface disease such as extensive limbal stem cell deficiency or keratinization
Prior use of cenegermin or certain topical medications within 7 days
Botox injections for tarsorrhaphy within 90 days
High-dose systemic corticosteroids within 30 days
Recent changes or planned changes in oral ocular surface medications within 30 days
Systemic opioid use within 30 days
Use of systemic or ocular investigational products, radiation, or chemotherapy within 90 days
Use or planned use of contact lenses in the study eye within 7 days or during the study
Anticipated need for punctal occlusion during the study
Acute severe systemic inflammatory diseases
Recent major surgical procedures or amniotic membrane therapy within 14 days
Partial tarsorrhaphy placed within 14 days prior to randomization

Research Team

Dompé farmaceutici S.p.A. Via Santa Lucia, 6, 20122 Milan (MI)

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Phase 3 Study to Evaluate Safety and Effectiveness of Cenegermin Eye Drops Compared to Placebo in Adults with Persistent Corneal Epithelial Defect

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria