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

October 20, 2025 updated by: Combangio, Inc

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1428ARF
        • Principal Investigator
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000
        • Principal Investigator
  • Puerto Rico
      • San Juan, Puerto Rico, 00921
        • Principal Investigator
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Principal Investigator
    • California
      • Irvine, California, United States, 92897
        • Principal Investigator
      • La Jolla, California, United States, 92037
        • Principal Investigator
      • Loma Linda, California, United States, 92354
        • Principal Investigator
      • Los Angeles, California, United States, 90013
        • Principal Investigator
      • Los Angeles, California, United States, 90095
        • Principal Investigator
      • Pasadena, California, United States, 91107
        • Principal Investigator
      • Rancho Cordova, California, United States, 95670
        • Principal Investigator
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Principal Investigator
      • Fort Collins, Colorado, United States, 80528
        • Principal Investigator
      • Littleton, Colorado, United States, 80120
        • Principal Investigator
    • Florida
      • Miami, Florida, United States, 33136
        • Principal Investigator
      • Miami, Florida, United States, 33143
        • Principal Investigator
      • Orange City, Florida, United States, 32763
        • Principal Investigator
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Principal Investigator
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Principal Investigator
      • Indianapolis, Indiana, United States, 46260
        • Principal Investigator
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Principal Investigator
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Principal Investigator
      • Boston, Massachusetts, United States, 02114
        • Principal Investigator
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Principal Investigator
      • Kansas City, Missouri, United States, 64111
        • Principal Investigator
      • Kansas City, Missouri, United States, 64133
        • Principal Investigator
      • St Louis, Missouri, United States, 63131
        • Principal Investigator
    • New Jersey
      • Palisades Park, New Jersey, United States, 07650
        • Principal Investigator
    • New York
      • New York, New York, United States, 10036
        • Principal Investigator
      • Rockville Centre, New York, United States, 11570
        • Principal Investigator
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Principal Investigator
      • Garner, North Carolina, United States, 27529
        • Principal Investigator
    • Ohio
      • Powell, Ohio, United States, 43065
        • Principal Investigator
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Principal Investigator
      • Pittsburgh, Pennsylvania, United States, 15219
        • Principal Investigator
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Principal Investigator
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Principal Investigator
      • Nashville, Tennessee, United States, 37215
        • Principal Investigator
    • Texas
      • Austin, Texas, United States, 78712
        • Principal Investigator
      • Austin, Texas, United States, 78731
        • Principal Investigator
      • Houston, Texas, United States, 77030
        • Principal Investigator
      • San Antonio, Texas, United States, 78212
        • Principal Investigator
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Principal Investigator
    • Washington
      • Seattle, Washington, United States, 98119
        • Principal Investigator
    • West Virginia
      • Morgantown, West Virginia, United States, 25606
        • Principal Investigator
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Principal Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. PCED measurements meet study criteria.

Exclusion Criteria:

  1. Any active ocular infection or any active infectious disease that could impact the PCED.
  2. Severe corneal burns in the Study Eye.
  3. Severe limbal stem cell deficiency in either eye.
  4. The circumference affected by limbal blood vessel ischemia greater than 75% of the circumference in the Study Eye.
  5. Severe blepharitis or severe meibomian gland disease.
  6. Severe eyelid abnormalities in the Study Eye, contributory to the persistence of the PCED.
  7. Evidence of corneal ulceration.
  8. Anticipated need for punctal occlusion.
  9. Use of Oxervate in the Study Eye within past 30 days.
  10. History of any surgical procedure for treatment of the study PCED.
  11. History of any other ocular surgery in the Study Eye within 90 days prior to screening.
  12. Not willing to suspend use of contact lens in the Study Eye.
  13. Any use of Botox injections to induce pharmacologic blepharoptosis in the 90 days.
  14. Expected use of systemic doxycycline.
  15. Any use of chemotherapeutic agents within 7 days prior to Study, or anticipated use during the study.
  16. History of current drug or alcohol abuse or addiction.
  17. Use of another investigational agent within 30 days.
  18. Participants who are pregnant, breastfeeding, or planning a pregnancy during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1, Arm 1
KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days
Drug: KPI-012
KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
Experimental: Cohort 2, Arm 1
KPI-012 Low Dose KPI-012 Ophthalmic Solution 1 U/mL 1 drop 4 times/day for 56 days
Drug: KPI-012
KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
Experimental: Cohort 2, Arm 2
KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days
Drug: KPI-012
KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
Placebo Comparator: Cohort 2, Arm 3
KPI-012 Vehicle KPI-012 Ophthalmic Solution 0 U/mL 1 drop 4 times/day for 56 days
Drug: KPI-012 Vehicle
KPI-012 formulation with no active drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response status
Time Frame: Day 56
Complete healing of the PCED and no corneal fluorescein staining in the area of the study lesion.
Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combangio, Inc

Collaborators

Kala Pharmaceuticals, Inc.

Investigators

  • Study Director: Kristie Veasey, Kala Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2023

Primary Completion (Actual)

September 29, 2025

Study Completion (Actual)

October 19, 2025

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Estimated)

October 22, 2025

Last Update Submitted That Met QC Criteria

October 20, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • KPI-012-C-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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