NCT05727878

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

A Study to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With Persistent Corneal Epithelial Defect (PCED)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Combangio, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 90 participants diagnosed with persistent corneal epithelial defect (PCED) will be enrolled at multiple US centers in a study to assess the safety and efficacy of KPI-012, a topical mesenchymal stem cell secretome therapy. After an initial cohort of at least 2 participants to evaluate the safety of the high strength product, participants in the second cohort will be randomized to treatment with either the product or vehicle (placebo) for 8 weeks. The percentage of healing will be compared between groups treated with product and vehicle. Total length of study participation will be approximately 34 weeks.

Conditions

• Persistent Corneal Epithelial Defect

Interventions

Type	Name	Description
DRUG	KPI-012	KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
DRUG	KPI-012 Vehicle	KPI-012 formulation with no active drug

Timeline

• Start date: 2023-02-07
• Primary completion: 2025-09-29
• Completion: 2025-10-19
• First posted: 2023-02-14
• Last updated: 2025-10-22

Locations

46 sites across 3 countries: United States, Argentina, Puerto Rico

Regulatory

• FDA-regulated drug study