Neurotrophic Keratitis
Conditions
Keywords
Neurotrophic Keratitis, NK
Brief 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.
Detailed 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 images to ensure objective, standardized, and unbiased grading. At the Week 8 visit, subjects will be assigned to open-label treatment with Lacripep 4 μM Ophthalmic Solution for 4 weeks, through Week 12. The initiation of 4 weeks of open-label active treatment is designed to explore the potential effects of both a shorter and a longer treatment period: i.e., 4 weeks of active treatment for subjects originally randomized to vehicle ophthalmic solution, and 12 total weeks of active treatment for subjects originally randomized to Lacripep 4 μM Ophthalmic Solution. Subjects will continue to dose TID in both eyes. All Week 1-8 treatment assignments will remain masked through database lock.
Interventions
DRUGLacripep
Lacripep 4 μM Ophthalmic Solution
OTHERVehicle Ophthalmic Solution
Vehicle ophthalmic solution
Sponsors
TearSolutions, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Eligible subjects will be randomized, in a double-masked fashion to either Lacripep Ophthalmic Solution or vehicle ophthalmic solution for treatment phase of the study. The IPs are identical in appearance and packaging. The masking scheme is dependent on the study period (treatment period vs. open label period).
Intervention model description
A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep Ophthalmic Solution in Subjects with Neurotrophic Keratitis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 least one eye: 1. 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. 2. BCDVA +0.2 to +1.0 logarithm of the minimum angle of resolution (logMAR) (Snellen equivalent 20/32 to 20/200). 3. IOP ≤21 mmHg.
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy | Baseline to Week 8 | Change from baseline in cCFS at Week 8 in Study Eye |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy | Baseline to Week 8 | Change from baseline in central corneal sensitivity at Week 8 in Study Eye |
Countries
United States
Contacts
CONTACTMarc Odrich, MD
CONTACTMichelle Carpenter
STUDY_DIRECTORMarc Odrich, MD
TearSolutions CMO
Outcome results
None listed