TERMINATED

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

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Conditions

Persistent Corneal Epithelial Defect

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-07
Study Completion:2025-10-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05727878

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. PCED measurements meet study criteria.
  1. 1. Any active ocular infection or any active infectious disease that could impact the PCED.
  2. 2. Severe corneal burns in the Study Eye.
  3. 3. Severe limbal stem cell deficiency in either eye.
  4. 4. The circumference affected by limbal blood vessel ischemia greater than 75% of the circumference in the Study Eye.
  5. 5. Severe blepharitis or severe meibomian gland disease.
  6. 6. Severe eyelid abnormalities in the Study Eye, contributory to the persistence of the PCED.
  7. 7. Evidence of corneal ulceration.
  8. 8. Anticipated need for punctal occlusion.
  9. 9. Use of Oxervate in the Study Eye within past 30 days.
  10. 10. History of any surgical procedure for treatment of the study PCED.
  11. 11. History of any other ocular surgery in the Study Eye within 90 days prior to screening.
  12. 12. Not willing to suspend use of contact lens in the Study Eye.
  13. 13. Any use of Botox injections to induce pharmacologic blepharoptosis in the 90 days.
  14. 14. Expected use of systemic doxycycline.
  15. 15. Any use of chemotherapeutic agents within 7 days prior to Study, or anticipated use during the study.
  16. 16. History of current drug or alcohol abuse or addiction.
  17. 17. Use of another investigational agent within 30 days.
  18. 18. Participants who are pregnant, breastfeeding, or planning a pregnancy during the study.

Contacts and Locations

Principal Investigator

Kristie Veasey
STUDY_DIRECTOR
Kala Pharmaceuticals, Inc.

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Combangio, Inc

  • Kristie Veasey, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-02-07
Study Completion Date2025-10-19

Study Record Updates

Study Start Date2023-02-07
Study Completion Date2025-10-19

Terms related to this study

Additional Relevant MeSH Terms

  • Persistent Corneal Epithelial Defect