Lacripep for Corneal Wound Healing Study

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Corneal Epithelial Wound Healing

In brief

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).

Key facts

Study ID: NCT06854393
Run by: Henry M. Jackson Foundation for the Advancement of Military Medicine
People needed: 88
Starts: 2025-05-23
Expected to finish: 2027-09-01
Last updated by the study team: 2026-03-25

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Alexander T. Augusta Military Medical Center — Fort Belvoir, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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