Lacripep for Corneal Wound Healing Study

March 24, 2026 updated by: Henry M. Jackson Foundation for the Advancement of Military Medicine

Lacripep, a Novel Investigational Agent, for Corneal Wound Healing and Ocular Surface Homeostasis

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the effect of an eyedrop medication, Lacripep, on wound healing in the cornea (the transparent tissue covering the front of the eye) such as seen after incidental or combat related trauma, or from eye surgeries like Photorefractive keratectomy (PRK). This study will help understand if Lacripep is an effective treatment in ocular surface healing and speeding visual recovery after injury.

Participants must be an active-duty service member or a dependent eligible for care at a military treatment facility.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female, of any race, 21 years old and older
  2. 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
  3. 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
  4. Stable refraction for the past year as demonstrated by a change in manifest refractive spherical equivalent of ≤ 0.50 diopters (D) in both eyes
  5. CDVA of at least 20/20 in both eyes
  6. Elected to undergo bilateral PRK
  7. Able to meet follow up requirements for up to 6-month period post-operatively

Exclusion Criteria:

  1. 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
  2. Signs of unstable or progressive myopia, keratoconus or keratoconus suspect in either eye
  3. Abnormal corneal topographic findings in either eye e.g., keratoconus, pellucid marginal degeneration
  4. Treatment targeted for monovision
  5. 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
  6. 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.
  7. 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
  8. Previous corneal or intraocular surgery in either eye for refractive or therapeutic purposes
  9. 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)
  10. 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.
  11. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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
Participant will receive Lacripep in one eye and placebo in the other eye at the same time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Lacripep
Time Frame: Epithelial thickness assessment will be performed at 4 and 7 days postoperatively then at 1, 3 and 6 months postoperatively.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lacripep safety
Time Frame: From enrollment to the end of treatment at 6 months
To determine the safety of Lacripep, the return of corrected distance visual acuity (CDVA) will be measured using high contrast visual acuity test. Return of CDVA will be defined as percentage of eyes with no more than 1 CDVA line lost from preoperative baseline.
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

Walter Reed National Military Medical Center
TearSolutions, Inc.

Investigators

  • Principal Investigator: Zachary P Skurski, DO, Alexander T. Augusta Military Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WRNMMC-2024-0470
  • HT94252411092 (Other Grant/Funding Number: HJF/USAMRAA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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