A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis
NCT07568730 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2026-05-11
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.
Conditions
Interventions
- DRUG
-
Lacripep
Lacripep 4 μM Ophthalmic Solution
- OTHER
-
Vehicle Ophthalmic Solution
Vehicle ophthalmic solution
Sponsors & Collaborators
-
TearSolutions, Inc.
lead INDUSTRY
Principal Investigators
-
Marc Odrich, MD · TearSolutions CMO
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-19
- Primary Completion
- 2027-02-28
- Completion
- 2027-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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