Actively Recruiting
A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis
Led by TearSolutions, Inc. · Updated on 2026-05-11
54
Participants Needed
3
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Provide informed consent before any study procedures
- Willing and able to follow study procedures and schedule
- Female participants must be unable to become pregnant or use effective birth control during the study
- Female participants of childbearing potential must have a negative pregnancy test and not be nursing
- Have Stage 1 neurotrophic keratitis in at least one eye, defined by Grade 3 corneal fluorescein staining and corneal sensitivity of 4 cm or less
- Have best-corrected distance visual acuity between +0.2 and +1.0 logMAR (20/32 to 20/200)
- Have intraocular pressure of 21 mmHg or less
You will not qualify if you...
- Prior treatment with Lacripep or Oxervate eye solutions within 6 months without meaningful response
- Participation in another neurotrophic keratitis study within 90 days
- Participation in any clinical study or use of investigational agents within 30 days before screening
- Glycated hemoglobin (HbA1c) above 9% within 90 days prior to screening
- History or current conditions such as ocular cicatricial pemphigoid, graft versus host disease, neuromyelitis optica, Stevens-Johnson syndrome, or Salzmann's nodular degeneration
- Unstable severe systemic or ocular allergy, chronic conjunctivitis or keratitis other than dry eye disease
- Diagnosed glaucoma or suspected glaucoma needing treatment
- Active ocular infection in either eye
- Any intraocular inflammation (Tyndall score greater than 0)
- Severe vision loss from retinal disease with no potential for improvement
- Eyelid abnormalities affecting function, such as blepharospasm or entropion
- Presence of punctal occlusion or plugs not maintained during the study
- Corneal surface procedures within 90 days before screening
- Neurotrophic keratitis caused by neurosurgical procedures
- Ocular surgery within 90 days prior or planned during the study
- History of viral corneal disease causing significant scarring
- Unstable viral corneal disease without scarring prior to screening
- Botox eye injections within 45 days prior to screening
- Use of non-study eye drops or neurostimulators within 14 days before baseline
- Need for therapeutic contact lenses or unwillingness to stop contact lens use during study
- Unstable medical conditions that may affect study data, including diabetes, thyroid disease, autoimmune diseases, Parkinson's, or multiple sclerosis
- Evidence of current drug or alcohol abuse
- Pregnancy, nursing, or planning pregnancy during the study
- Employment or immediate family relation to the study site staff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Midwest Cornea Associates
Carmel, Indiana, United States, 46032
Actively Recruiting
2
Minnesota Eye Consultants
Minneapolis, Minnesota, United States, 55431
Actively Recruiting
3
Ophthalmology Associates
St Louis, Missouri, United States, 63131
Not Yet Recruiting
Research Team
M
Marc Odrich, MD
CONTACT
M
Michelle Carpenter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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