Not Yet RecruitingPhase 3

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

150 participantsStarted 2026-04-30

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 range18 Years

SexALL

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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
✕. 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

What they're measuring

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)

+39 02 583 831

View on ClinicalTrials.gov More Persistent Corneal Epithelial Defect trials