Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-01 @ 9:47 PM
Study NCT ID:
NCT07105332
Status:
TERMINATED
Last Update Posted:
2025-08-05
First Post:
2022-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Trial of a Sub-conjunctival Insert
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'terminated after the concept feasibility was succesfully proved, no safety issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2022-09-05', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between OMI signal and blood glucose', 'timeFrame': '1-2 times weekly for 10 weeks after insertion', 'description': 'Correlation between OMI fluorescence readings of subconjunctival interstitial fluid glucose concentration and capillary blood glucose level'}, {'measure': 'Adverse Events Reporting', 'timeFrame': 'at each visit, up to 10 months', 'description': 'wound healing and conjunctival hyperaemia'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and signal to noise ratio of the photometer', 'timeFrame': '1-2 times weekly for 10 weeks after insertion'}, {'measure': 'Long term stability of insert', 'timeFrame': '1-2 times weekly for 10 weeks after insertion', 'description': 'signal drift and stability of measurement'}, {'measure': 'Targeting of measurement beam', 'timeFrame': '1-2 times weekly for 10 weeks after insertion'}, {'measure': 'Subjective impressions', 'timeFrame': '10 months', 'description': 'subjecs has to answer a questionnaire'}, {'measure': 'Lag time', 'timeFrame': '1-2 times weekly for 10 weeks after insertion', 'description': 'evaluation between device readings and blood glucose concentration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sub-conjunctival implant', 'flash glucose monitoring', 'EyeSense, eye implant, glucose measurement in the eye'], 'conditions': ['Diabetes (DM)']}, 'descriptionModule': {'briefSummary': 'The purpose of this single-centre, open label prospective study is to investigate a novel ocular mini insert (OMI) for detection of blood glucose levels in human subjects. First, the optimal technical parameters for measurement are determined on healthy subjects. Secondly, performance measurements follow investigating relationship between OMI signal and blood glucose in diabetes patients during short sessions with oral glucose tolerace test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Be of legal age or alternatively above 16 with written persmission of legal guardian.\n2. Signed written Informed Consent.\n\nExclusion Criteria:\n\n1. Pregnant or lactating females.\n2. Poorly controlled diabetes mellitus with prior hemoglobin A1C greater than 10% or fasting glucose over 150 mg/dl.\n3. Any known allergies, especially iodine.\n4. Glaucoma patient.\n5. Any acute disease.\n6. Any present condition that would prevent from fasting or glucose challenge.\n7. Any present condition that would prevent from insertion.'}, 'identificationModule': {'nctId': 'NCT07105332', 'acronym': 'OMI', 'briefTitle': 'Feasibility Trial of a Sub-conjunctival Insert', 'organization': {'class': 'INDUSTRY', 'fullName': 'EyeSense GmbH'}, 'officialTitle': 'Investigation of a Sub-Conjunctival Insert', 'orgStudyIdInfo': {'id': 'P-1.1-C-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort - Healthy subjects', 'description': '2 healthy subjects will test OMI and Photometer for a period of up to 5 months: with sub-conjunctivaly implanted OMI participating on in-clinic sessions to optimize and adjust the measurement system (photometer).', 'interventionNames': ['Device: OMI and Photometer']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort - Diabetic patients', 'description': '8 diabetic patients will test OMI and Photometer: wearing sub-conjunctivaly implanted OMI for a period of up to 10 months and participating on up to 20 in-clinic sessions with blood glucose challenge to measure the performance of the system.', 'interventionNames': ['Device: OMI and Photometer']}], 'interventions': [{'name': 'OMI and Photometer', 'type': 'DEVICE', 'description': 'A glucose sensitive ocular mini insert (OMI) is placed sub-conjunctivaly. When exited by photometer the glucose concentration is measured.', 'armGroupLabels': ['Cohort - Diabetic patients', 'Cohort - Healthy subjects']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Holger Mietz, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '63739 Aschaffenburg, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EyeSense GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}