A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the … (NCT07568730) | Clinical Trial Compass
RecruitingPhase 2
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
United States54 participantsStarted 2026-02-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. BCDVA +0.2 to +1.0 logarithm of the minimum angle of resolution (logMAR) (Snellen equivalent 20/32 to 20/200).
✓. IOP ≤21 mmHg.
Exclusion criteria
✕. 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).
✕. Have a history of or current conditions that may confound the study data; such conditions include but are not limited to ocular cicatricial pemphigoid, graft versus host disease, neuromyelitis optica, Stevens-Johnson syndrome, and Salzmann's nodular degeneration.
✕. Have an unstable history of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the study period) or chronic conjunctivitis and/or keratitis other than dry eye disease.
✕. Have been diagnosed with glaucoma or are a glaucoma suspect who requires or may require treatment during the study.
✕. Have, in the opinion of the Investigator, evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.