Lacripep for Corneal Wound Healing Study

Official title

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

Overview

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).

Detailed 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 or a dependent eligible for care at a military treatment facility.

Interventions

• Drug 0.00025% Lacripep ophthalmic solution and Placebo
  Participant will receive Lacripep in one eye and placebo in the other eye at the same time.

Primary outcome measures

• Efficacy of Lacripep [Time frame: Epithelial thickness assessment will be performed at 4 and 7 days postoperatively then at 1, 3 and 6 months postoperatively.]

Secondary outcome measures (1)

• Lacripep safety [Time frame: From enrollment to the end of treatment at 6 months]

Eligibility criteria

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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Alexander T. Augusta Military Medical Center — Fort Belvoir

Publications

• Yulek F, Ozdek S, Gurelik G, Hasanreisoglu B. Effect of topical steroids on corneal epithelial healing after vitreoretinal surgery. Acta Ophthalmol Scand. 2006 Jun;84(3):319-22. doi: 10.1111/j.1600-0420.2005.00632.x. PMID 16704691
• Wong HL, Poon SHL, Bu Y, Lo ACY, Jhanji V, Chan YK, Shih KC. A Systematic Review on Cornea Epithelial-Stromal Homeostasis. Ophthalmic Res. 2021;64(2):178-191. doi: 10.1159/000509030. Epub 2020 May 29. PMID 32474566
• Wolsey D, Slade S, Wirostko BM, Brandano LA, Mann BK, Durrie DS, Thompson V. Novel Cross-Linked Ocular Bandage Gel Improves Reepithelialization After Photorefractive Keratectomy: A Randomized, Masked Prospective Study. J Ocul Pharmacol Ther. 2020 Oct;36(8):602-608. doi: 10.1089/jop.2019.0156. Epub 2020 Jul 17. PMID 32701012
• Wilson SE. Interleukin-1 and Transforming Growth Factor Beta: Commonly Opposing, but Sometimes Supporting, Master Regulators of the Corneal Wound Healing Response to Injury. Invest Ophthalmol Vis Sci. 2021 Apr 1;62(4):8. doi: 10.1167/iovs.62.4.8. PMID 33825855
• Wilson SE. Corneal wound healing. Exp Eye Res. 2020 Aug;197:108089. doi: 10.1016/j.exer.2020.108089. Epub 2020 Jun 15. PMID 32553485
• Weng TH, Chang YM, Lin FH, Weng ZX, Wang TW, Chen YH, Tai MC, Chen JT, Liang CM, Lin TY. Investigation of corneal epithelial thickness and irregularity by optical coherence tomography after transepithelial photorefractive keratectomy. Clin Exp Optom. 2024 Jan;107(1):23-31. doi: 10.1080/08164622.2023.2197107. Epub 2023 Apr 20. PMID 37078178
• Weichel ED, Colyer MH, Ludlow SE, Bower KS, Eiseman AS. Combat ocular trauma visual outcomes during operations iraqi and enduring freedom. Ophthalmology. 2008 Dec;115(12):2235-45. doi: 10.1016/j.ophtha.2008.08.033. PMID 19041478
• Wang W, Despanie J, Shi P, Edman-Woolcott MC, Lin YA, Cui H, Heur JM, Fini ME, Hamm-Alvarez SF, MacKay JA. Lacritin-mediated regeneration of the corneal epithelia by protein polymer nanoparticles. J Mater Chem B. 2014 Dec 14;2(46):8131-8141. doi: 10.1039/C4TB00979G. PMID 25530855

Identifiers

NCT: NCT06854393 · WRNMMC-2024-0470 · HT94252411092

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗