Trial to Evaluate Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants With PCED
NCT ID: NCT05727878
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
103 participants
INTERVENTIONAL
2023-02-07
2025-10-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1, Arm 1
KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days
KPI-012
KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
Cohort 2, Arm 1
KPI-012 Low Dose KPI-012 Ophthalmic Solution 1 U/mL 1 drop 4 times/day for 56 days
KPI-012
KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
Cohort 2, Arm 2
KPI-012 High Dose KPI-012 Ophthalmic Solution 3 U/mL 1 drop 4 times/day for 56 days
KPI-012
KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
Cohort 2, Arm 3
KPI-012 Vehicle KPI-012 Ophthalmic Solution 0 U/mL 1 drop 4 times/day for 56 days
KPI-012 Vehicle
KPI-012 formulation with no active drug
Interventions
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KPI-012
KPI-012 is a secretome product composed of biologically active components secreted from human bone marrow-derived mesenchymal stem cells
KPI-012 Vehicle
KPI-012 formulation with no active drug
Eligibility Criteria
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Inclusion Criteria
2. PCED measurements meet study criteria.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Kala Pharmaceuticals, Inc.
INDUSTRY
Combangio, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Kristie Veasey
Role: STUDY_DIRECTOR
Kala Pharmaceuticals, Inc.
Locations
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Principal Investigator
Dothan, Alabama, United States
Principal Investigator
Irvine, California, United States
Principal Investigator
La Jolla, California, United States
Principal Investigator
Loma Linda, California, United States
Principal Investigator
Los Angeles, California, United States
Principal Investigator
Los Angeles, California, United States
Principal Investigator
Pasadena, California, United States
Principal Investigator
Rancho Cordova, California, United States
Principal Investigator
Aurora, Colorado, United States
Principal Investigator
Fort Collins, Colorado, United States
Principal Investigator
Littleton, Colorado, United States
Principal Investigator
Miami, Florida, United States
Principal Investigator
Miami, Florida, United States
Principal Investigator
Orange City, Florida, United States
Principal Investigator
Atlanta, Georgia, United States
Principal Investigator
Carmel, Indiana, United States
Principal Investigator
Indianapolis, Indiana, United States
Principal Investigator
Louisville, Kentucky, United States
Principal Investigator
Boston, Massachusetts, United States
Principal Investigator
Boston, Massachusetts, United States
Principal Investigator
Chesterfield, Missouri, United States
Principal Investigator
Kansas City, Missouri, United States
Principal Investigator
Kansas City, Missouri, United States
Principal Investigator
St Louis, Missouri, United States
Principal Investigator
Palisades Park, New Jersey, United States
Principal Investigator
New York, New York, United States
Principal Investigator
Rockville Centre, New York, United States
Principal investigator
Durham, North Carolina, United States
Principal Investigator
Garner, North Carolina, United States
Principal Investigator
Powell, Ohio, United States
Principal Investigator
Philadelphia, Pennsylvania, United States
Principal Investigator
Pittsburgh, Pennsylvania, United States
Principal Investigator
Rapid City, South Dakota, United States
Principal Investigator
Memphis, Tennessee, United States
Principal Investigator
Nashville, Tennessee, United States
Principal Investigator
Austin, Texas, United States
Principal Investigator
Austin, Texas, United States
Principal Investigator
Houston, Texas, United States
Principal Investigator
San Antonio, Texas, United States
Principal Investigator
Norfolk, Virginia, United States
Principal Investigator
Seattle, Washington, United States
Principal Investigator
Morgantown, West Virginia, United States
Principal Investigator
Kenosha, Wisconsin, United States
Principal Investigator
Caba, Buenos Aires, Argentina
Principal Investigator
Rosario, Santa Fe Province, Argentina
Principal Investigator
San Juan, , Puerto Rico
Countries
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Other Identifiers
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KPI-012-C-001
Identifier Type: -
Identifier Source: org_study_id
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