Actively Recruiting
Lacripep for Corneal Wound Healing Study
Led by Henry M. Jackson Foundation for the Advancement of Military Medicine · Updated on 2026-03-25
88
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
Sponsors
H
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead Sponsor
T
TearSolutions, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Lacripep for Corneal Wound Healing Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 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 months postoperatively
- Desire refractive correction of myopia up to -4.00 diopters sphere with or without astigmatism 0 to -1.50 diopters in both eyes
- Stable refraction for the past year with a change in spherical equivalent of 0.50 diopters or less in both eyes
- Corrected distance visual acuity of at least 20/20 in both eyes
- Elected to undergo bilateral PRK
- Able to meet follow-up requirements for up to 6 months postoperatively
You will not qualify if you...
- Calculated ablation depth greater than 75 microns or need for prophylactic MMC
- Unstable or progressive myopia, keratoconus or keratoconus suspect in either eye
- Abnormal corneal topography such as pellucid marginal degeneration
- Treatment targeted for monovision
- Signs or symptoms of dry eye: corneal fluorescein staining score 4 or higher, anesthetized Schirmer test score 5 mm/5 min or less, or symptom score 40 or higher using SANDE questionnaire
- Pregnant, breastfeeding, or intending to become pregnant during the study
- Residual, recurrent, or active ocular diseases or corneal abnormalities including 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 for refractive or therapeutic purposes
- Use of medications that may impair healing such as corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride, or sumatriptan
- Medical conditions that may impair healing including collagen vascular disease, autoimmune disease, immunodeficiency, ocular herpes zoster or simplex
- Individuals not legally competent to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Alexander T. Augusta Military Medical Center
Fort Belvoir, Virginia, United States, 22060
Actively Recruiting
Research Team
Z
Zachary P Skurski, DO
CONTACT
R
Rose Sia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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