54 Participants NeededMy employer runs this trial

Lacripep for Neurotrophic Keratopathy

Recruiting at 2 trial locations
MO
MC
Overseen ByMichelle Carpenter
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MO

Marc Odrich, MD

Principal Investigator

TearSolutions CMO

Are You a Good Fit for This Trial?

Inclusion Criteria

Subjects who meet all the following inclusion criteria at Visit 1 (Screening) will be eligible to participate in the study.
I am 18 years old or older.
2. Provide informed consent before any study-related procedures are performed.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Run-in

Participants receive open-label vehicle ophthalmic solution

2 weeks
1 visit (in-person)

Treatment

Participants are randomized to receive either Lacripep 4 μM Ophthalmic Solution or vehicle ophthalmic solution, dosed TID in both eyes

8 weeks
3 visits (in-person) at Week 2, Week 4, and Week 8

Open-label Extension

Participants receive open-label Lacripep 4 μM Ophthalmic Solution, dosed TID in both eyes

4 weeks
1 visit (in-person) at Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lacripep

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: LacripepExperimental Treatment1 Intervention
Group II: VehiclePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

TearSolutions, Inc.

Lead Sponsor

Trials
2
Recruited
290+