Lacripep for Corneal Wound Healing Study

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status and phase: Enrolling; Phase 2

Conditions: Corneal Epithelial Wound Healing

Treatments: Drug: 0.00025% Lacripep ophthalmic solution and Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT06854393

WRNMMC-2024-0470

HT94252411092 (Other Grant/Funding Number)

Details and patient eligibility

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).

Full 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 eligible for care at a military treatment facility.

Enrollment: 88 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, of any race, 21 years old and older
2. Active-duty U.S. military service members eligible for care
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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Drug: 0.00025% Lacripep ophthalmic solution and Placebo