Lacripep for Corneal Wound Healing Study

NCT06854393 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: WRNMMC-2024-0470HT94252411092
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of Lacripep as a therapy for superficial corneal injury repair after Photorefractive keratectomy (PRK).

Conditions

Corneal Epithelial Wound Healing

Keywords

Cornea; Wound healing; PRK; Lacritin; Lacripep

Outcome Measures

Primary Outcomes (1)

• Efficacy of Lacripep

  To determine the efficacy of Lacripep for corneal wound healing, epithelial thickness will be be measured using optical coherence tomography (OCT). OCT is a non-invasive imaging technique that uses light waves to create detailed images of tissue structures.

  Epithelial thickness assessment will be performed at 4 and 7 days postoperatively then at 1, 3 and 6 months postoperatively.

Secondary Outcomes (1)

• Lacripep safety

  From enrollment to the end of treatment at 6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Participants will receive Lacripep in one eye and placebo in the other eye at the same time.

Drug: 0.00025% Lacripep ophthalmic solution and Placebo

Interventions

0.00025% Lacripep ophthalmic solution and Placebo DRUG

Participant will receive Lacripep in one eye and placebo in the other eye at the same time.

Treatment

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, of any race, 21 years old and older
• Active-duty U.S. military service members or their dependents eligible for care at Alexander T. Augusta Military Medical Center for 6-month period postoperatively
• Desiring refractive correction of myopia up to -4.00 diopters (D) sphere with or without astigmatism 0 to -1.50 D and up to -4.00 D manifest spherical equivalent in both eyes
• Stable refraction for the past year as demonstrated by a change in manifest refractive spherical equivalent of ≤ 0.50 diopters (D) in both eyes
• CDVA of at least 20/20 in both eyes
• Elected to undergo bilateral PRK
• Able to meet follow up requirements for up to 6-month period post-operatively

You may not qualify if:

• Calculated ablation depth of greater than 75 microns or other conditions in either eye which in the judgement of the investigators will require use of prophylactic MMC
• Signs of unstable or progressive myopia, keratoconus or keratoconus suspect in either eye
• Abnormal corneal topographic findings in either eye e.g., keratoconus, pellucid marginal degeneration
• Treatment targeted for monovision
• Signs and symptoms of dry eye based on: (a) Corneal fluorescein staining total score ≥4 in the National Eye Institute (NEI)/Industry Workshop scale in either eye, (b) Anethetized Schirmer test score ≤5 mm/5 minutes in either eye, (c) Symptom score ≤40 using the Symptom Assessment in Dry Eye (SANDE) questionnaire in either eye
• Female subjects who are pregnant, breastfeeding or intend to become pregnant during the study. Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not.
• Residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as iritis, uveitis, keratoconjunctivitis sicca, herpetic keratitis, vernal conjunctivitis, lagophthalmos, corneal scarring, anterior basement membrane disease, recurrent erosions, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts
• Previous corneal or intraocular surgery in either eye for refractive or therapeutic purposes
• Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane®), amiodarone hydrochloride (Cordarone®) and/or sumatriptan (Imitrex®) (other medications in the same family as Imitrex will still be allowed)
• Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
• Individuals not legally competent to provide informed consent (e.g., incapacitated individuals, cognitively impaired) will not be enrolled. All subjects must provide consent to participate in the study

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• TearSolutions, Inc.: collaborator
• Walter Reed National Military Medical Center: collaborator

Study Sites (1)

Alexander T. Augusta Military Medical Center

Fort Belvoir, Virginia, 22060, United States

RECRUITING

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MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Zachary P Skurski, DO

  Alexander T. Augusta Military Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zachary P Skurski, DO

CONTACT

571-231-1670; Zachary.p.skurski.mil@health.mil

Rose Sia

CONTACT

rosekristine.c.sia.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Participant will receive both active treatment and placebo at the same time. One eye will receive active treatment (Lacripep) and the other eye will receive placebo.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will: 1. Undergo photorefractive keratectomy (PRK), which is an eye surgery to improve vision. 2. Use two types of experimental eyedrops three times a day for three weeks. There will be separate containers of eyedrops for the right eye and the left eye. One eye will get the active eyedrop (Lacripep) and the other eye will get the placebo eyedrop (saline).

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 3, 2025
• Study Start: May 23, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)