KPI-012 - Clinical Trial

What is the 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).

What is the Condition Being Studied?

Persistent Corneal Epithelial Defect (PCED)

Who Can Participate in the Study?

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.

Age Group
Adults

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.

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
Ophthalmologist
Protocol Number
IRB: PRO00112928
NCT: NCT05727878
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment