Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT06854393
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lacripep for Corneal Wound Healing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003316', 'term': 'Corneal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participant will receive both active treatment and placebo at the same time. One eye will receive active treatment (Lacripep) and the other eye will receive placebo.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will:\n\n1. Undergo photorefractive keratectomy (PKR), which is an eye surgery to improve vision.\n2. Use two types of experimental eyedrops three times a day for three weeks. There will be separate containers of eyedrops for the right eye and the left eye. One eye will get the active eyedrop (Lacripep) and the other eye will get the placebo eyedrop (saline).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-02-18', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Lacripep', 'timeFrame': 'Epithelial thickness assessment will be performed at 4 and 7 days postoperatively then at 1, 3 and 6 months postoperatively.', 'description': 'To determine the efficacy of Lacripep for corneal wound healing, epithelial thickness will be be measured using optical coherence tomography (OCT). OCT is a non-invasive imaging technique that uses light waves to create detailed images of tissue structures.'}], 'secondaryOutcomes': [{'measure': 'Lacripep safety', 'timeFrame': 'From enrollment to the end of treatment at 6 months', 'description': 'To determine the safety of Lacripep, the return of corrected distance visual acuity (CDVA) will be measured using high contrast visual acuity test. Return of CDVA will be defined as percentage of eyes with no more than 1 CDVA line lost from preoperative baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cornea', 'Wound healing', 'PRK', 'Lacritin', 'Lacripep'], 'conditions': ['Corneal Epithelial Wound Healing']}, 'referencesModule': {'references': [{'pmid': '16704691', 'type': 'BACKGROUND', 'citation': 'Yulek F, Ozdek S, Gurelik G, Hasanreisoglu B. Effect of topical steroids on corneal epithelial healing after vitreoretinal surgery. 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Epub 2019 Jun 22.'}, {'pmid': '30632489', 'type': 'BACKGROUND', 'citation': 'Bandeira F, Yusoff NZ, Yam GH, Mehta JS. Corneal re-innervation following refractive surgery treatments. Neural Regen Res. 2019 Apr;14(4):557-565. doi: 10.4103/1673-5374.247421.'}, {'type': 'BACKGROUND', 'citation': 'Ashby BD, Garrett Q, Willcox MDP. Corneal injuries and wound healing - review of processes and therapies. Austin J Clin Ophthalmol. 2014;1(4): 1017.'}, {'pmid': '11709022', 'type': 'BACKGROUND', 'citation': 'Andreotti G, Lange JL, Brundage JF. The nature, incidence, and impact of eye injuries among US military personnel: implications for prevention. Arch Ophthalmol. 2001 Nov;119(11):1693-7. doi: 10.1001/archopht.119.11.1693.'}, {'pmid': '25863420', 'type': 'BACKGROUND', 'citation': 'Amparo F, Schaumberg DA, Dana R. Comparison of Two Questionnaires for Dry Eye Symptom Assessment: The Ocular Surface Disease Index and the Symptom Assessment in Dry Eye. Ophthalmology. 2015 Jul;122(7):1498-503. doi: 10.1016/j.ophtha.2015.02.037. Epub 2015 Apr 8.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nParticipants must be an active-duty service member eligible for care at a military treatment facility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, of any race, 21 years old and older\n2. Active-duty U.S. military service members eligible for care\n3. 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\n4. Stable refraction for the past year as demonstrated by a change in manifest refractive spherical equivalent of ≤ 0.50 diopters (D) in both eyes\n5. CDVA of at least 20/20 in both eyes\n6. Elected to undergo bilateral PRK\n7. Able to meet follow up requirements for up to 6-month period post-operatively\n\nExclusion Criteria:\n\n1. 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\n2. Signs of unstable or progressive myopia, keratoconus or keratoconus suspect in either eye\n3. Abnormal corneal topographic findings in either eye e.g., keratoconus, pellucid marginal degeneration\n4. Treatment targeted for monovision\n5. 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\n6. 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.\n7. 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\n8. Previous corneal or intraocular surgery in either eye for refractive or therapeutic purposes\n9. 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)\n10. 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.\n11. 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'}, 'identificationModule': {'nctId': 'NCT06854393', 'briefTitle': 'Lacripep for Corneal Wound Healing Study', 'organization': {'class': 'OTHER', 'fullName': 'Henry M. Jackson Foundation for the Advancement of Military Medicine'}, 'officialTitle': 'Lacripep, a Novel Investigational Agent, for Corneal Wound Healing and Ocular Surface Homeostasis', 'orgStudyIdInfo': {'id': 'WRNMMC-2024-0470'}, 'secondaryIdInfos': [{'id': 'HT94252411092', 'type': 'OTHER_GRANT', 'domain': 'HJF/USAMRAA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Participants will receive Lacripep in one eye and placebo in the other eye at the same time.', 'interventionNames': ['Drug: 0.00025% Lacripep ophthalmic solution and Placebo']}], 'interventions': [{'name': '0.00025% Lacripep ophthalmic solution and Placebo', 'type': 'DRUG', 'description': 'Participant will receive Lacripep in one eye and placebo in the other eye at the same time.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22060', 'city': 'Fort Belvoir', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zachary P Skurski', 'role': 'CONTACT', 'email': 'dha.belvoir.fbch.mbx.wresp-research@health.mil', 'phone': '571-231-1600'}, {'name': 'Thomas Jenkins', 'role': 'CONTACT', 'email': 'dha.belvoirfbch.mbx.wresp-research@health.mil', 'phone': '571-231-1600'}, {'name': 'Zachary P Skurski', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alexander T. Augusta Military Medical Center', 'geoPoint': {'lat': 38.7119, 'lon': -77.14589}}], 'centralContacts': [{'name': 'Zachary P Skurski, DO', 'role': 'CONTACT', 'email': 'Zachary.p.skurski.mil@health.mil', 'phone': '571-231-1670'}, {'name': 'Thomas Jenkins', 'role': 'CONTACT', 'email': 'thomas.jenkins194.ctr@health.mil', 'phoneExt': '571-231-1670'}], 'overallOfficials': [{'name': 'Zachary P Skurski, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexander T. Augusta Military Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry M. Jackson Foundation for the Advancement of Military Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'TearSolutions, Inc.', 'class': 'INDUSTRY'}, {'name': 'Walter Reed National Military Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}