A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep 4 μM Ophthalmic Solution in Subjects With Neurotrophic Keratitis
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.
⁃ Subjects who meet all the following inclusion criteria at Visit 1 (Screening) will be eligible to participate in the study.
• 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 all of the following in at least one eye:
‣ Stage 1 NK as defined by:
• Grade 3 cCFS using the National Eye Institute (NEI) scale (0-3 in one-point increments).
∙ Corneal sensitivity ≤4 cm in the central zone, as measured by Cochet-Bonnet aesthesiometer.
⁃ BCDVA +0.2 to +1.0 logarithm of the minimum angle of resolution (logMAR) (Snellen equivalent 20/32 to 20/200).
⁃ IOP ≤21 mmHg.