Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-01 @ 10:50 PM
Study NCT ID:
NCT07155057
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of DED in Patients Undergoing Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-12', 'size': 215638, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-04T14:56', 'hasProtocol': True}, {'date': '2025-08-12', 'size': 186058, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-09-04T14:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to 3- month visit in non-invasive tear break up time (NITBUT) in primary eyes as measured by a non-invasive, automated ocular surface analyzer.', 'timeFrame': '3 months', 'description': "Tear Break-Up time. Tear breakup time (TBUT) is a clinical measurement that assesses the stability of the tear film on the surface of the eye. It measures the time it takes for dry spots to form on the cornea after a complete blink. A rapid breakup indicates tear film instability, which is a common cause of dry eye syndrome.\n\nInterpreting TBUT results:\n\nA person's TBUT score is an indicator of their tear film health.\n\nNormal: A TBUT of 10 seconds or more typically signifies a healthy and stable tear film.\n\nMarginal/Mild to Moderate Instability: A score of 5 to 9 seconds may suggest mild to moderate tear film instability.\n\nLow/Dry Eye: A score of less than 5 seconds is a strong indicator of dry eye syndrome caused by tear film dysfunction."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dry Eye Disease (DED)']}, 'descriptionModule': {'briefSummary': 'To review how patients report using a hyaluronate crosslinked canalicular gel placed before cataract surgery', 'detailedDescription': 'Prospective, single-site, single-arm study enrolling 60 patients who have elected advanced IOL implantation at the time of cataract surgery and have a diagnosis of dry eye disease. The study will consist of 5 study visits, over a 3-5 month time period. Patients will receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel pre-operatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be willing and able to understand and sign the informed consent form (ICF)\n* Men or non-pregnant women age 22 or older\n* Clear intraocular media other than cataract\n* Diagnosis of dry eye disease (OSDI score ≥ 13)\n* Non-invasive Tear break up time ≤ 10 seconds in at least one eye\n* Willing and able to comply with all study related visits and procedures\n* In the opinion of the investigator, patients who are appropriate for advanced technology lens implants\n\nExclusion Criteria:\n\n* History of punctal cautery\n* Lacrimal anatomy (e.g., nasolacrimal duct obstruction) that per investigator suggests that the patient would not be a good candidate for lacrimal occlusion or patients for whom lacrimal occlusion would increase risk'}, 'identificationModule': {'nctId': 'NCT07155057', 'acronym': 'LaReCa', 'briefTitle': 'Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of DED in Patients Undergoing Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Vance Thompson Vision'}, 'officialTitle': 'A Prospective, Single-Arm Study Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of Dry Eye Disease in Patients Undergoing Refractive Cataract Surgery', 'orgStudyIdInfo': {'id': 'Lacrifill IIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study Participants', 'description': 'Patients will receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel pre-operatively', 'interventionNames': ['Device: Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML']}], 'interventions': [{'name': 'Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML', 'type': 'DEVICE', 'description': 'Prospective, single-site, single-arm study enrolling 60 patients who have elected advanced IOL implantation at the time of cataract surgery and have a diagnosis of dry eye disease. The study will consist of 5 study visits, over a 3-5 month time period. Patients will receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel pre-operatively', 'armGroupLabels': ['Study Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tiffany R Facile', 'role': 'CONTACT', 'email': 'tiffany.facile@vancethompsonvision.com'}, {'name': 'Kristin Dunne', 'role': 'CONTACT', 'email': 'kristin.dunne@vancethompsonvision.com'}], 'facility': 'Vance Thompson Vision Clinic, Prof. LLC', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}], 'centralContacts': [{'name': 'Tiffany Facile', 'role': 'CONTACT', 'email': 'tiffany.facile@vancethompsonvision.com', 'phone': '605-371-7075'}], 'overallOfficials': [{'name': 'Kayla Karpuk, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vance Thompson Vision Clinic Prof. LLC'}, {'name': 'Vance Thompson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vance Thompson Vision Clinic Prof. LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vance Thompson Vision', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}