54 Participants NeededMy employer runs this trial

Lacripep for Neurotrophic Keratopathy

Recruiting at 5 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?

This trial tests Lacripep, an eye solution, to determine its safety and effectiveness for people with Stage 1 neurotrophic keratopathy (NK), a condition affecting the eye's surface that can cause corneal numbness. Researchers aim to understand how Lacripep impacts eye health, vision, and overall quality of life for those with this condition. Participants will receive either Lacripep or a placebo (a solution with no active ingredient). This trial may suit individuals diagnosed with Stage 1 NK in at least one eye who experience issues like reduced corneal sensitivity. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in eye health.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use any non-study issued eye drops or neurostimulators within 14 days before the trial starts.

Is there any evidence suggesting that Lacripep is likely to be safe for humans?

Studies have shown that Lacripep is generally safe for use. Previous research confirmed its safety for patients with moderate to severe conditions, with very few reports of serious side effects. This suggests that Lacripep can safely treat eye conditions like neurotrophic keratopathy, which affects the cornea. Although researchers are still studying Lacripep for this specific use, its past safety record in other trials offers reassurance for potential participants.12345

Why do researchers think this study treatment might be promising for neurotrophic keratopathy?

Most treatments for neurotrophic keratopathy focus on providing artificial tears or ointments to lubricate the eye or, in more severe cases, surgical interventions to protect the cornea. But Lacripep works differently, targeting the underlying problem by using a synthetic peptide designed to promote healing of the corneal nerves. Researchers are excited about Lacripep because it addresses the root cause of the condition rather than just alleviating symptoms, offering the potential for a more effective and long-lasting solution.

What evidence suggests that Lacripep might be an effective treatment for Neurotrophic Keratopathy?

Research has shown that Lacripep, which participants in this trial may receive, may help treat eye problems like neurotrophic keratopathy. Studies indicate that Lacripep's artificial tear protein can repair damage to the eye's surface caused by dry eye conditions. Known for its healing ability, it is particularly effective in cases with nerve damage or ongoing eye surface issues. Early evidence suggests it might effectively heal and stabilize the eye surface, improving vision and comfort. Additionally, Lacripep has shown few side effects, with only mild irritation in a small number of patients.15678

Who Is on the Research Team?

MO

Marc Odrich, MD

Principal Investigator

TearSolutions CMO

Are You a Good Fit for This Trial?

This trial is for adults (18+) with early-stage neurotrophic keratitis, reduced corneal sensitivity, and certain vision levels. Participants must have normal eye pressure, be able to follow study procedures, and women of childbearing age must use birth control and not be pregnant or nursing.

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.
See 6 more

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

Trial Overview

The study compares Lacripep eye drops to a placebo (vehicle solution) in people with neurotrophic keratitis. It aims to see if Lacripep is safe and helps improve the surface of the eye, vision quality, corneal sensitivity, and overall quality of life.

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+

Citations

Study Details | NCT07568730 | A Multicenter, Randomized ...

The study will compare Lacripep 4 μM Ophthalmic Solution to vehicle ophthalmic solution for the treatment of Stage 1 neurotrophic keratitis ...

Long-term clinical efficacy of topical treatment with ... - PMC

The results of this study demonstrated that long-term one 8 week course of cenegermin was effective in restoring ocular surface homeostasis in ...

TearSolutions planning Phase II/III trials for therapy to treat ...

... Lacripep for the treatment of ... (COPE Track) Neurotrophic Keratitis: Multidisciplinary Approaches to Enhance Patient Outcomes.

A synthetic tear protein resolves dry eye through promoting ...

We reveal that topical application of the synthetic tear protein Lacripep reverses the pathological outcomes of dry eye through restoring the extensive network ...

The Evolving Landscape of Dry-eye Therapeutics

“Lacripep stands out for its regenerative properties, particularly in patients with neurotrophic components or chronic epithelial instability,” ...

Lacripep for Neurotrophic Keratopathy

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 ...

Lacripep - Drug Targets, Indications, Patents

Purpose: The purpose of this study was to assess the safety, tolerability, dosing, and efficacy of the active 19 amino acid fragment of lacritin (Lacripep), a ...

Neurotrophic keratopathy: Update in diagnosis and ... - PMC

This review presents a comprehensive update on NK, focusing on current as well as potential new strategies for its diagnosis and management.