Objective: To evaluate the safety of Lacripep 4 μM Ophthalmic Solution and its effect on the ocular surface, visual function, corneal sensitivity, and quality of life of subjects with Stage 1 NK.
Are ≥18 years of age.
Provide informed consent before any study-related procedures are performed.
Are willing and able to comply with study procedures and the study schedule.
Female subjects must either be incapable of pregnancy or must use an effective method of birth control for the duration of the study. Female subjects of childbearing potential must have a negative pregnancy test and not be nursing.
Have received prior treatment with Lacripep Ophthalmic Solution or Oxervate® (cenegermin-bkbj) Ophthalmic Solution within 6 months prior to Visit 1 (Screening) and failed to demonstrate a clinically meaningful response, as determined by the Investigator.
Have participated in a NK study within 90 days prior to Visit 1 (Screening).
Have participated in any other clinical study or used an investigational agent within 30 days prior to Screening or plans to participate in another clinical study at any time during the conduct of this study.
Have a glycated hemoglobin (HbA1c) score >9% within 90 days prior to Visit 1 (Screening).
Parallel
Lacripep
DrugLacripep 4 μM Ophthalmic Solution
Vehicle Ophthalmic Solution
Other interventionVehicle ophthalmic solution
Primary Efficacy
Change from baseline in cCFS at Week 8 in Study Eye
Secondary Efficacy
Change from baseline in central corneal sensitivity at Week 8 in Study Eye
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