Purpose of this Study
This is a research study to see if two doses (low and high) of the KPI-012 eye drops are safe and work to repair persistent corneal epithelial defects (PCED), a non-healing corneal wound that does not heal with standard treatments, compared to the placebo (eye drops without any active ingredients).
Who Can Participate?
Eligibility
Adults age 18 and older who:
- Have been diagnosed with PCED for at least 7 days
- Does not heal with traditional treatments
- Do not have any active eye redness not related to PCED
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
- Have been diagnosed with PCED for at least 7 days
- Does not heal with traditional treatments
- Do not have any active eye redness not related to PCED
For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.
What is Involved?
If you choose to join the study, you will:
- Administer 1 eye drop, 4 times a day for 2 months of either: KPI-012 high dose eye drops, or KPI-012 low dose eye drops, or placebo eye drops;
- Be in touch with the study team for about 9 months
- Visit our clinic at the Duke Eye Center for up to 9 study visits and 2 phone calls.
At various visits, you will have blood tests, you will answer some questionnaires, and have eye exams and vision tests.
- Administer 1 eye drop, 4 times a day for 2 months of either: KPI-012 high dose eye drops, or KPI-012 low dose eye drops, or placebo eye drops;
- Be in touch with the study team for about 9 months
- Visit our clinic at the Duke Eye Center for up to 9 study visits and 2 phone calls.
At various visits, you will have blood tests, you will answer some questionnaires, and have eye exams and vision tests.
Study Details
Full Title
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)
Principal Investigator
Amol
Sura
Protocol Number
PRO00112928
NCT ID
NCT05727878
Phase
II
Enrollment Status
Open to Enrollment