RECRUITING

Lacripep for Corneal Wound Healing Study

Conditions

Corneal Epithelial Wound Healing Cornea Wound healing PRK Lacritin Lacripep

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-05-23

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06854393

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.

Ages Eligible for Study:21 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Zachary P Skurski, DO

CONTACT

571-231-1670

Zachary.p.skurski.mil@health.mil

Thomas Jenkins

CONTACT

thomas.jenkins194.ctr@health.mil

Principal Investigator

Zachary P Skurski, DO

PRINCIPAL_INVESTIGATOR

Alexander T. Augusta Military Medical Center

Study Locations (Sites)

Alexander T. Augusta Military Medical Center

Fort Belvoir, Virginia, 22060

United States

Collaborators and Investigators

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Zachary P Skurski, DO, PRINCIPAL_INVESTIGATOR, Alexander T. Augusta Military Medical Center

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 Registration Dates

Study Start Date2025-05-23

Study Completion Date2027-09

Study Record Updates

Study Start Date2025-05-23

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Cornea
Wound healing
PRK
Lacritin
Lacripep

Additional Relevant MeSH Terms

Corneal Epithelial Wound Healing