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

Last updated: October 20, 2025
Sponsor: Combangio, Inc
Overall Status: Terminated

Phase

2

Condition

N/A

Treatment

KPI-012

KPI-012 Vehicle

Clinical Study ID

NCT05727878
KPI-012-C-001
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Have PCED for at least 7 days prior due to an underlying condition such as diabetickeratopathy, herpetic eye disease, severe dry eye disease, limbal stem celldeficiency, infectious keratitis, neurotrophic keratitis, post ocular surgery,medical trauma, chemical burn, etc.

  2. PCED measurements meet study criteria.

Exclusion

Exclusion Criteria:

  1. Any active ocular infection or any active infectious disease that could impact thePCED.

  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 thecircumference 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 thePCED.

  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 toscreening.

  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 useduring 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 thestudy.

Study Design

Total Participants: 103
Treatment Group(s): 2
Primary Treatment: KPI-012
Phase: 2
Study Start date:
February 07, 2023
Estimated Completion Date:
October 19, 2025

Study 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.

Connect with a study center

  • Principal Investigator

    Caba, Buenos Aires 3435907 C1428ARF
    Argentina

    Site Not Available

  • Principal Investigator

    Rosario, Santa Fe S2000
    Argentina

    Site Not Available

  • Principal Investigator

    Rosario 3838583, Santa Fe Province 3836276 S2000
    Argentina

    Site Not Available

  • Principal Investigator

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Principal Investigator

    San Juan 4568127, 00921
    Puerto Rico

    Site Not Available

  • Principal Investigator

    Dothan, Alabama 36301
    United States

    Site Not Available

  • Principal Investigator

    Dothan 4059102, Alabama 4829764 36301
    United States

    Site Not Available

  • Principal Investigator

    Irvine, California 92897
    United States

    Site Not Available

  • Principal Investigator

    La Jolla, California 92037
    United States

    Site Not Available

  • Principal Investigator

    Loma Linda, California 92354
    United States

    Site Not Available

  • Principal Investigator

    Los Angeles, California 90095
    United States

    Site Not Available

  • Principal Investigator

    Pasadena, California 91107
    United States

    Site Not Available

  • Principal Investigator

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • Principal Investigator

    Irvine 5359777, California 5332921 92897
    United States

    Site Not Available

  • Principal Investigator

    La Jolla 5363943, California 5332921 92037
    United States

    Site Not Available

  • Principal Investigator

    Loma Linda 5367696, California 5332921 92354
    United States

    Site Not Available

  • Principal Investigator

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Principal Investigator

    Pasadena 5381396, California 5332921 91107
    United States

    Site Not Available

  • Principal Investigator

    Rancho Cordova 5385941, California 5332921 95670
    United States

    Site Not Available

  • Principal Investigator

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Principal Investigator

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Principal Investigator

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Principal Investigator

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Principal Investigator

    Fort Collins 5577147, Colorado 5417618 80528
    United States

    Site Not Available

  • Principal Investigator

    Littleton 5429032, Colorado 5417618 80120
    United States

    Site Not Available

  • Principal Investigator

    Miami, Florida 33136
    United States

    Site Not Available

  • Principal Investigator

    Orange City, Florida 32763
    United States

    Site Not Available

  • Principal Investigator

    Miami 4164138, Florida 4155751 33143
    United States

    Site Not Available

  • Principal Investigator

    Orange City 4167055, Florida 4155751 32763
    United States

    Site Not Available

  • Principal Investigator

    Atlanta, Georgia 30339
    United States

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  • Principal Investigator

    Atlanta 4180439, Georgia 4197000 30339
    United States

    Site Not Available

  • Principal Investigator

    Carmel, Indiana 46290
    United States

    Site Not Available

  • Principal Investigator

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Principal Investigator

    Carmel 4255466, Indiana 4921868 46290
    United States

    Site Not Available

  • Principal Investigator

    Indianapolis 4259418, Indiana 4921868 46260
    United States

    Site Not Available

  • Principal Investigator

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Principal Investigator

    Louisville 4299276, Kentucky 6254925 40206
    United States

    Site Not Available

  • Principal Investigator

    Boston, Massachusetts 02114
    United States

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  • Principal Investigator

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Principal Investigator

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Principal Investigator

    Kansas City, Missouri 64133
    United States

    Site Not Available

  • Principal Investigator

    Saint Louis, Missouri 63131
    United States

    Site Not Available

  • Principal Investigator

    Chesterfield 4381072, Missouri 4398678 63017
    United States

    Site Not Available

  • Principal Investigator

    Kansas City 4393217, Missouri 4398678 64133
    United States

    Site Not Available

  • Principal Investigator

    St Louis 4407066, Missouri 4398678 63131
    United States

    Site Not Available

  • Principal Investigator

    Palisades Park, New Jersey 07650
    United States

    Site Not Available

  • Principal Investigator

    Palisades Park 5102369, New Jersey 5101760 07650
    United States

    Site Not Available

  • Principal Investigator

    New York, New York 10036
    United States

    Site Not Available

  • Principal Investigator

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • Principal Investigator

    New York 5128581, New York 5128638 10036
    United States

    Site Not Available

  • Principal Investigator

    Rockville Centre 5134203, New York 5128638 11570
    United States

    Site Not Available

  • Principal investigator

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Principal Investigator

    Garner, North Carolina 27529
    United States

    Site Not Available

  • Principal investigator

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Principal Investigator

    Garner 4467657, North Carolina 4482348 27529
    United States

    Site Not Available

  • Principal Investigator

    Powell, Ohio 43065
    United States

    Site Not Available

  • Principal Investigator

    Powell 5167350, Ohio 5165418 43065
    United States

    Site Not Available

  • Principal Investigator

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Principal Investigator

    Pittsburgh, Pennsylvania 15219
    United States

    Site Not Available

  • Principal Investigator

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Principal Investigator

    Pittsburgh 5206379, Pennsylvania 6254927 15219
    United States

    Site Not Available

  • Principal Investigator

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Principal Investigator

    Rapid City 5768233, South Dakota 5769223 57701
    United States

    Site Not Available

  • Principal Investigator

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Principal Investigator

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Principal Investigator

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Site Not Available

  • Principal Investigator

    Nashville 4644585, Tennessee 4662168 37215
    United States

    Site Not Available

  • Principal Investigator

    Austin, Texas 78712
    United States

    Site Not Available

  • Principal Investigator

    Houston, Texas 77030
    United States

    Site Not Available

  • Principal Investigator

    San Antonio, Texas 78212
    United States

    Site Not Available

  • Principal Investigator

    Austin 4671654, Texas 4736286 78712
    United States

    Site Not Available

  • Principal Investigator

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Principal Investigator

    San Antonio 4726206, Texas 4736286 78212
    United States

    Site Not Available

  • Principal Investigator

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Principal Investigator

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Site Not Available

  • Principal Investigator

    Seattle, Washington 98119
    United States

    Site Not Available

  • Principal Investigator

    Seattle 5809844, Washington 5815135 98119
    United States

    Site Not Available

  • Principal Investigator

    Morgantown, West Virginia 25606
    United States

    Site Not Available

  • Principal Investigator

    Morgantown 4815352, West Virginia 4826850 25606
    United States

    Site Not Available

  • Principal Investigator

    Kenosha, Wisconsin 53142
    United States

    Site Not Available

  • Principal Investigator

    Kenosha 5258393, Wisconsin 5279468 53142
    United States

    Site Not Available

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