Persistent corneal epithelial defect (PCED) is a persistent non-healing corneal defect or wound. KPI-012 is a novel, human bone-marrow derived human mesenchymal stem cell (hMSC) secretome composed of biologically active components, which have been shown in preclinical studies and early clinical trials to facilitate corneal healing. This study will investigate the efficacy and safety of KPI-012 eye drops 4 times daily for 8-weeks for healing of PCED.
KPI-012-C-001
A Study to Evaluate the Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants with Persistent Corneal Epithelial Defect (PCED)
Corneal disorders
All genders
18+
Recruiting now
Overview
Principal Investigator: Pedram Hamrah, MD
Contact Us
Karaghan Curran
Study details
Inclusion Criteria
- Have a medically documented persistent corneal epithelial defect (PCED) of at least 7 days duration
- Be willing and able, to self-administer antibiotic eye drops up to 3 times a day, and preservative-free artificial tears up to four times per day for duration of study.
- The persistent corneal epithelial defect (PCED) is measured at Screening as follows:
a. minimum of 1 mm of any linear measurement of defect
b. maximum of 8 mm of any linear measurement of defect
Exclusion Criteria
- Anticipated use of topical ocular treatment in the Study Eye any time after screening for the duration of study.
- Active ocular infection
- Previous use of Oxervate within the last 30 days prior to screening
Study Requirements
This study requires a total of 9 visits to your eye doctors office over approximately 35 weeks. There will be a screening period/7-day wash-out of current eye drops, followed by a 8-week treatment period, where participants will self-administer study eye drops 4 times daily. There will then be follow-up visits at 2 weeks and additionally 6 months after treatment is completed. There will be a total of 3 blood collections, once at the beginning of the study, and twice during follow-up.