RecruitingPhase 2

Lacripep for Corneal Wound Healing Study

United States88 participantsStarted 2025-05-23

Plain-language 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).

Who can participate

Age range21 Years – 55 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Efficacy of Lacripep

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

Trial details

NCT IDNCT06854393

SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Zachary P Skurski, DO

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

View on ClinicalTrials.gov More Corneal Epithelial Wound Healing trials