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

NCT05727878 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: KPI-012-C-001
• Study Type: interventional
• Target: 103
• Locations: 3 countries
• Sites: 46

Brief 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

Outcome Measures

Primary Outcomes (1)

• Response status

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

  Day 56

Study Arms (4)

Cohort 1, Arm 1

EXPERIMENTAL

KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days

Drug: KPI-012

Cohort 2, Arm 1

EXPERIMENTAL

KPI-012 Low Dose KPI-012 Ophthalmic Solution 1 U/mL 1 drop 4 times/day for 56 days

Drug: KPI-012

Cohort 2, Arm 2

EXPERIMENTAL

KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days

Drug: KPI-012

Cohort 2, Arm 3

PLACEBO COMPARATOR

KPI-012 Vehicle KPI-012 Ophthalmic Solution 0 U/mL 1 drop 4 times/day for 56 days

Drug: KPI-012 Vehicle

Interventions

KPI-012 DRUG

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

Cohort 1, Arm 1; Cohort 2, Arm 1; Cohort 2, Arm 2

KPI-012 Vehicle DRUG

KPI-012 formulation with no active drug

Cohort 2, Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Combangio, Inc: lead
• Kala Pharmaceuticals, Inc.: collaborator

Study Sites (46)

Principal Investigator

Dothan, Alabama, 36301, United States

Location

Principal Investigator

Irvine, California, 92897, United States

Location

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La Jolla, California, 92037, United States

Location

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Loma Linda, California, 92354, United States

Location

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Los Angeles, California, 90013, United States

Location

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Los Angeles, California, 90095, United States

Location

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Pasadena, California, 91107, United States

Location

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Rancho Cordova, California, 95670, United States

Location

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Aurora, Colorado, 80045, United States

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Fort Collins, Colorado, 80528, United States

Location

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Littleton, Colorado, 80120, United States

Location

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Miami, Florida, 33136, United States

Location

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Miami, Florida, 33143, United States

Location

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Orange City, Florida, 32763, United States

Location

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Atlanta, Georgia, 30339, United States

Location

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Carmel, Indiana, 46290, United States

Location

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Indianapolis, Indiana, 46260, United States

Location

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Louisville, Kentucky, 40206, United States

Location

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Boston, Massachusetts, 02111, United States

Location

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Boston, Massachusetts, 02114, United States

Location

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Chesterfield, Missouri, 63017, United States

Location

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Kansas City, Missouri, 64111, United States

Location

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Kansas City, Missouri, 64133, United States

Location

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St Louis, Missouri, 63131, United States

Location

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Palisades Park, New Jersey, 07650, United States

Location

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New York, New York, 10036, United States

Location

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Rockville Centre, New York, 11570, United States

Location

Principal investigator

Durham, North Carolina, 27710, United States

Location

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Garner, North Carolina, 27529, United States

Location

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Powell, Ohio, 43065, United States

Location

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Philadelphia, Pennsylvania, 19107, United States

Location

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Pittsburgh, Pennsylvania, 15219, United States

Location

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Rapid City, South Dakota, 57701, United States

Location

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Memphis, Tennessee, 38119, United States

Location

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Nashville, Tennessee, 37215, United States

Location

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Austin, Texas, 78712, United States

Location

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Austin, Texas, 78731, United States

Location

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Houston, Texas, 77030, United States

Location

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San Antonio, Texas, 78212, United States

Location

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Norfolk, Virginia, 23502, United States

Location

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Seattle, Washington, 98119, United States

Location

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Morgantown, West Virginia, 25606, United States

Location

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Kenosha, Wisconsin, 53142, United States

Location

Principal Investigator

Caba, Buenos Aires, C1428ARF, Argentina

Location

Principal Investigator

Rosario, Santa Fe Province, S2000, Argentina

Location

Principal Investigator

San Juan, 00921, Puerto Rico

Location

Study Officials

• Kristie Veasey

  Kala Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Cohort 1: open-label Cohort 2: masked to participant, Investigator, site staff, outcomes assessor, etc
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 14, 2023
• Study Start: February 7, 2023
• Primary Completion: September 29, 2025
• Study Completion: October 19, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (43); AR (2)