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
TearSolutions, Inc.
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.
Description
The study will compare Lacripep 4 μM Ophthalmic Solution to vehicle ophthalmic solution for the treatment of Stage 1 neurotrophic keratitis (NK). Approximately 54 subjects will be enrolled and will enter a 2-week run-in period with open-label vehicle ophthalmic solution. At Visit 2 (Day 1; Baseline/Randomization), eligible subjects will be randomized to either Lacripep 4 μM Ophthalmic Solution or vehicle ophthalmic solution. Subjects will dose three times a day (TID) in both eyes (OU) for 8 weeks, with clinic visits at Week 2, Week 4, and Week 8. A central reading center will assess study ima…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects who meet all the following inclusion criteria at Visit 1 (Screening) will be eligible to participate in the study. 1. Are ≥18 years of age. 2. Provide informed consent before any study-related procedures are performed. 3. Are willing and able to comply with study procedures and the study schedule. 4. 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. 5. Have all of the following in at…
Interventions
- DrugLacripep
Lacripep 4 μM Ophthalmic Solution
- OtherVehicle Ophthalmic Solution
Vehicle ophthalmic solution
Locations (3)
- Midwest Cornea AssociatesCarmel, Indiana
- Minnesota Eye ConsultantsMinneapolis, Minnesota
- Ophthalmology AssociatesSt Louis, Missouri