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Persistent Corneal Epithelial DefectPhase 2CHASENCT05727878

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

A Phase 2 study testing KPI-012 in people with Persistent Corneal Epithelial Defect, run by Combangio, Inc at 46 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Persistent Corneal Epithelial Defect
What is being tested?
KPI-012
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
103 participants
Where
46 sitesin 3 countries
Study dates
7 Feb 2023to 19 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • Evidence of corneal ulceration.
  • Anticipated need for punctal occlusion.
  • Use of Oxervate in the Study Eye within past 30 days.
  • History of any surgical procedure for treatment of the study PCED.
  • History of any other ocular surgery in the Study Eye within 90 days prior to screening.
  • Not willing to suspend use of contact lens in the Study Eye.
  • Any use of Botox injections to induce pharmacologic blepharoptosis in the 90 days.
  • Expected use of systemic doxycycline.
  • Any use of chemotherapeutic agents within 7 days prior to Study, or anticipated use during the study.
  • History of current drug or alcohol abuse or addiction.
  • Use of another investigational agent within 30 days.
  • Participants who are pregnant, breastfeeding, or planning a pregnancy during the study.

Trial locations and contacts

46 sites in 3 countries.

46 sites in 3 countries

United States43 sites

  • Principal Investigator

    Atlanta, Georgia, 30339

  • Principal Investigator

    Aurora, Colorado, 80045

  • Principal Investigator

    Austin, Texas, 78712

  • Principal Investigator

    Austin, Texas, 78731

  • Principal Investigator

    Boston, Massachusetts, 02111

  • Principal Investigator

    Boston, Massachusetts, 02114

  • Principal Investigator

    Carmel, Indiana, 46290

  • Principal Investigator

    Chesterfield, Missouri, 63017

  • Principal Investigator

    Dothan, Alabama, 36301

  • Principal investigator

    Durham, North Carolina, 27710

  • Principal Investigator

    Fort Collins, Colorado, 80528

  • Principal Investigator

    Garner, North Carolina, 27529

  • Principal Investigator

    Houston, Texas, 77030

  • Principal Investigator

    Indianapolis, Indiana, 46260

  • Principal Investigator

    Irvine, California, 92897

  • Principal Investigator

    Kansas City, Missouri, 64111

  • Principal Investigator

    Kansas City, Missouri, 64133

  • Principal Investigator

    Kenosha, Wisconsin, 53142

  • Principal Investigator

    La Jolla, California, 92037

  • Principal Investigator

    Littleton, Colorado, 80120

  • Principal Investigator

    Loma Linda, California, 92354

  • Principal Investigator

    Los Angeles, California, 90013

  • Principal Investigator

    Los Angeles, California, 90095

  • Principal Investigator

    Louisville, Kentucky, 40206

  • Principal Investigator

    Memphis, Tennessee, 38119

  • Principal Investigator

    Miami, Florida, 33136

  • Principal Investigator

    Miami, Florida, 33143

  • Principal Investigator

    Morgantown, West Virginia, 25606

  • Principal Investigator

    Nashville, Tennessee, 37215

  • Principal Investigator

    New York, New York, 10036

  • Principal Investigator

    Norfolk, Virginia, 23502

  • Principal Investigator

    Orange City, Florida, 32763

  • Principal Investigator

    Palisades Park, New Jersey, 07650

  • Principal Investigator

    Pasadena, California, 91107

  • Principal Investigator

    Philadelphia, Pennsylvania, 19107

  • Principal Investigator

    Pittsburgh, Pennsylvania, 15219

  • Principal Investigator

    Powell, Ohio, 43065

  • Principal Investigator

    Rancho Cordova, California, 95670

  • Principal Investigator

    Rapid City, South Dakota, 57701

  • Principal Investigator

    Rockville Centre, New York, 11570

  • Principal Investigator

    San Antonio, Texas, 78212

  • Principal Investigator

    Seattle, Washington, 98119

  • Principal Investigator

    St Louis, Missouri, 63131

Other trials in United States

Argentina2 sites

  • Principal Investigator

    Caba, Buenos Aires, C1428ARF

  • Principal Investigator

    Rosario, Santa Fe Province, S2000

Other trials in Argentina

Puerto Rico1 site

  • Principal Investigator

    San Juan, 00921

Other trials in Puerto Rico

About this study

Official title: 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.

Read the 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.

Being tested
KPI-012, KPI-012 Vehicle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KPI-012Drug

    KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells

  • KPI-012 VehicleDrug

    KPI-012 formulation with no active drug

Study groups in NCT05727878
Study groupRoleWhat they receive
Cohort 1, Arm 1ExperimentalKPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days
Receives: Drug: KPI-012
Cohort 2, Arm 1ExperimentalKPI-012 Low Dose KPI-012 Ophthalmic Solution 1 U/mL 1 drop 4 times/day for 56 days
Receives: Drug: KPI-012
Cohort 2, Arm 2ExperimentalKPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days
Receives: Drug: KPI-012
Cohort 2, Arm 3Placebo comparatorKPI-012 Vehicle KPI-012 Ophthalmic Solution 0 U/mL 1 drop 4 times/day for 56 days
Receives: Drug: KPI-012 Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response status

    Complete healing of the PCED and no corneal fluorescein staining in the area of the study lesion.

    Measured: Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2023
  2. Study start7 Feb 2023
  3. Primary completion29 Sep 2025
  4. Study completion19 Oct 2025

Why it stopped: Lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05727878
Sponsor's protocol ID
KPI-012-C-001
Acronym
CHASE
Status last verified
Oct 2025
First submitted
6 Feb 2023
Last updated
22 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KPI-012 in people with Persistent Corneal Epithelial Defect, run by Combangio, Inc at 46 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Argentina, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response status (time frame: Day 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05727878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.

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