TerminatedPhase 2

Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED

Stopped: Lack of efficacy

United States103 participantsStarted 2023-02-07

Plain-language summary

The primary objective of the study is to investigate the safety and efficacy of KPI-012 compared to vehicle in participants who have a documented clinical diagnosis of PCED.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Have PCED for at least 7 days prior due to an underlying condition such as diabetic keratopathy, herpetic eye disease, severe dry eye disease, limbal stem cell deficiency, infectious keratitis, neurotrophic keratitis, post ocular surgery, medical trauma, chemical burn, etc.
✓. PCED measurements meet study criteria.

Exclusion criteria

✕. Any active ocular infection or any active infectious disease that could impact the PCED.
✕. Severe corneal burns in the Study Eye.
✕. Severe limbal stem cell deficiency in either eye.
✕. The circumference affected by limbal blood vessel ischemia greater than 75% of the circumference in the Study Eye.
✕. Severe blepharitis or severe meibomian gland disease.
✕. Severe eyelid abnormalities in the Study Eye, contributory to the persistence of the PCED.
✕. Evidence of corneal ulceration.
✕. Anticipated need for punctal occlusion.

What they're measuring

Response status

Timeframe: Day 56

Trial details

NCT IDNCT05727878

SponsorCombangio, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-29

View on ClinicalTrials.gov More Persistent Corneal Epithelial Defect trials