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

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.

Conditions

Persistent Corneal Epithelial Defect

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Persistent Corneal Epithelial Defect
Intervention / Treatment

-

Contacts and Locations

Dothan

Principal Investigator, Dothan, Alabama, United States, 36301

Irvine

Principal Investigator, Irvine, California, United States, 92897

La Jolla

Principal Investigator, La Jolla, California, United States, 92037

Loma Linda

Principal Investigator, Loma Linda, California, United States, 92354

Los Angeles

Principal Investigator, Los Angeles, California, United States, 90013

Los Angeles

Principal Investigator, Los Angeles, California, United States, 90095

Pasadena

Principal Investigator, Pasadena, California, United States, 91107

Rancho Cordova

Principal Investigator, Rancho Cordova, California, United States, 95670

Aurora

Principal Investigator, Aurora, Colorado, United States, 80045

Fort Collins

Principal Investigator, Fort Collins, Colorado, United States, 80528

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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. PCED measurements meet study criteria.
  • 1. Any active ocular infection or any active infectious disease that could impact the PCED.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Combangio, Inc,

Kristie Veasey, STUDY_DIRECTOR, Kala Pharmaceuticals, Inc.

Study Record Dates

2025-10