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

NCT05727878 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-10-22

No results posted yet for this study

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.

Conditions

  • Persistent Corneal Epithelial Defect

Interventions

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

Sponsors & Collaborators

  • Kala Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Combangio, Inc

    lead INDUSTRY

Principal Investigators

  • Kristie Veasey · Kala Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2025-09-29
Completion
2025-10-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05727878 on ClinicalTrials.gov