A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep 4 μM Ophthalmic Solution in Subjects With Neurotrophic Keratitis

NCT07568730 | Recruiting Phase 2 FDA Drug

• 1 other identifier: TS-NK-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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.

Conditions

Neurotrophic Keratitis

Keywords

Neurotrophic Keratitis; NK

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy

  Change from baseline in cCFS at Week 8 in Study Eye

  Baseline to Week 8

Secondary Outcomes (1)

• Secondary Efficacy

  Baseline to Week 8

Study Arms (2)

Lacripep

EXPERIMENTAL

Drug: Lacripep

Vehicle

PLACEBO COMPARATOR

Other: Vehicle Ophthalmic Solution

Interventions

Lacripep DRUG

Lacripep 4 μM Ophthalmic Solution

Lacripep

Vehicle Ophthalmic Solution OTHER

Vehicle ophthalmic solution

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are ≥18 years of age.
• Provide informed consent before any study-related procedures are performed.
• Are willing and able to comply with study procedures and the study schedule.
• 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.
• Have all of the following in at least one eye:
• 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.
• BCDVA +0.2 to +1.0 logarithm of the minimum angle of resolution (logMAR) (Snellen equivalent 20/32 to 20/200).
• IOP ≤21 mmHg.

You may not qualify if:

• Have received prior treatment with Lacripep Ophthalmic Solution or Oxervate® (cenegermin-bkbj) Ophthalmic Solution within 6 months prior to Visit 1 (Screening) and failed to demonstrate a clinically meaningful response, as determined by the Investigator.
• Have participated in a NK study within 90 days prior to Visit 1 (Screening).
• Have participated in any other clinical study or used an investigational agent within 30 days prior to Screening or plans to participate in another clinical study at any time during the conduct of this study.
• Have a glycated hemoglobin (HbA1c) score \>9% within 90 days prior to Visit 1 (Screening).
• Have a history of or current conditions that may confound the study data; such conditions include but are not limited to ocular cicatricial pemphigoid, graft versus host disease, neuromyelitis optica, Stevens-Johnson syndrome, and Salzmann's nodular degeneration.
• Have an unstable history of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the study period) or chronic conjunctivitis and/or keratitis other than dry eye disease.
• Have been diagnosed with glaucoma or are a glaucoma suspect who requires or may require treatment during the study.
• Have, in the opinion of the Investigator, evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.
• Have any intraocular inflammation (Tyndall score \>0).
• Have, in the opinion of the Investigator, severe vision loss due to retinal disease, with no potential for visual improvement.
• Have an eyelid abnormality that may alter eyelid function; such abnormalities include but are not limited to blepharospasm, cerebrovascular accident, entropion, ectropion, and floppy lid syndrome.
• Have punctal occlusion or punctal plugs that will not be maintained during the study period.
• Have had any corneal surface procedure within 90 days prior to Visit 1 (Screening). This includes laser-assisted in situ keratomileusis (LASIK), phototherapeutic or photorefractive keratectomy (PTK or PRK), radial keratotomy (RK), small-incision lenticule extraction (SMILE), penetrating keratoplasty (PK), automated lamellar keratoplasty (ALK), deep anterior lamellar keratoplasty (DALK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping endothelial keratoplasty (DSEK), superior limbic keratoconjunctivitis (SLK) surgery, and placement of any amniotic membrane.
• Have, in the opinion of the Investigator, NK that was induced by a neurosurgical procedure.
• Have undergone any other ocular surgery (including peripheral iridotomy (PI), laser iridotomy (LI) eyelid surgery and any surgical refractive procedures) within 90 days prior to Visit 1 (Screening) or expect to undergo ocular surgery during the study period.

Sponsors & Collaborators

• TearSolutions, Inc.: lead

Study Sites (3)

Midwest Cornea Associates

Carmel, Indiana, 46032, United States

RECRUITING

Minnesota Eye Consultants

Minneapolis, Minnesota, 55431, United States

RECRUITING

Ophthalmology Associates

St Louis, Missouri, 63131, United States

NOT YET RECRUITING

Study Officials

• Marc Odrich, MD

  TearSolutions CMO

  STUDY DIRECTOR

Central Study Contacts

Marc Odrich, MD

CONTACT

646.249.2800; modrich@tearsolutions.com

Michelle Carpenter

CONTACT

mcarpenter@rpspharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 6, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (3)