Actively Recruiting
A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep 4 M Ophthalmic Solution in Subjects With Neurotrophic Keratitis
Led by TearSolutions, Inc. · Updated on 2026-05-11
54
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Lacripep 4 M Ophthalmic Solution in people with Stage 1 neurotrophic keratitis (NK), a condition affecting the cornea. This Phase 2 study compares Lacripep to a vehicle ophthalmic solution to see how each affects the eye surface, vision, corneal sensitivity, and quality of life. The trial involves about 54 participants and includes detailed eye image assessments by a central reading center to ensure objective results. Participants will first undergo a 2-week run-in period using the vehicle ophthalmic solution openly. Then, at the baseline visit, they are randomly assigned to receive either Lacripep 4 M or the vehicle solution. Both treatments are applied three times daily to both eyes for 8 weeks, with clinic visits at weeks 2, 4, and 8. After this, all participants enter a 4-week open-label phase where everyone receives Lacripep, allowing comparison of shorter and longer treatment durations. During the study, participants will have regular clinic visits for eye exams and assessments to monitor safety and effects on vision and corneal health. Researchers will measure the primary efficacy from baseline to week 8 and continue safety monitoring through week 12. The study includes checks on visual acuity, corneal sensitivity, and intraocular pressure, along with quality-of-life evaluations. Overall participation lasts about 12 weeks, including both masked and open-label treatment phases.
CONDITIONS
Brief 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...
- Are 18 years of age or older
- Provide informed consent before any study procedures
- Willing and able to follow study procedures and schedule
- Female participants must be non-pregnant, not nursing, and use effective birth control if of childbearing potential with a negative pregnancy test
- Have Stage 1 neurotrophic keratitis in at least one eye with Grade 3 corneal staining on NEI scale and corneal sensitivity 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 21 mmHg or less
You will not qualify if you...
- Prior treatment with Lacripep or Oxervate within 6 months without meaningful response
- Participation in a neurotrophic keratitis study within 90 days
- Participation in other clinical studies or use of investigational agents within 30 days
- HbA1c greater than 9% within 90 days
- History or current ocular conditions that may affect study data, including cicatricial pemphigoid and Stevens-Johnson syndrome
- Severe or unstable ocular allergies, conjunctivitis, or keratitis other than dry eye disease
- Diagnosis or suspicion of glaucoma requiring treatment
- Active ocular infection or intraocular inflammation
- Severe vision loss from retinal disease without improvement potential
- Eyelid abnormalities affecting function
- Punctal occlusion or plugs not maintained during study
- Recent corneal surface procedures or ocular surgeries within 90 days
- Neurotrophic keratitis caused by neurosurgical procedures
- History of significant viral corneal disease or unstable viral corneal disease
- Botox ocular injections within 45 days
- 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
- Unstable medical conditions affecting study data like diabetes or autoimmune diseases
- Evidence of drug or alcohol abuse
- Pregnancy, nursing, or planning pregnancy during study
- Employment or immediate family employment at the study site
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants use open-label vehicle ophthalmic solution for 2 weeks before randomization.
1 visit (in-person) at the end of run-in
Duration - 8 weeks
Participants are randomized to receive either Lacripep 4 μM Ophthalmic Solution or vehicle ophthalmic solution three times a day in both eyes for 8 weeks.
Clinic visits at Week 2, Week 4, and Week 8
Duration - 4 weeks
Participants receive open-label Lacripep 4 μM Ophthalmic Solution three times a day in both eyes for an additional 4 weeks to explore longer treatment effects.
1 visit (in-person) at Week 12
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
M
Michelle Carpenter
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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