Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-03-04 @ 1:41 AM
Study NCT ID:
NCT04031118
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Corneal Oxygen Uptake With Apioc Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-22', 'size': 801775, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-22T14:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-09', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal Oxygen Uptake Rate', 'timeFrame': 'up to 45 seconds', 'description': 'uptake of oxygen by human cornea in vivo'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine if a new investigational contact lens shape allows the eye to get more oxygen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide informed consent.\n2. Appear willing and able to adhere to instructions set forth in the protocol.\n3. Be between the ages of 18 and 45.\n4. Be an experienced contact lens wearer.\n5. Be an eyecare clinician or clinician-in-training.\n6. Flat and steep keratometry readings within 40 to 50D.\n7. Clear, healthy corneas with no irregular astigmatism.\n8. Normal, healthy conjunctiva in both eyes.\n9. Be able to provide corneal topography measurements.\n10. Be able to provide manifest refraction measurements.\n\nExclusion Criteria:\n\n1. Irregular corneal astigmatism.\n2. Use of topical or systemic antihistamines within the previous week.\n3. Use of topical ophthalmic drops within the previous two days.\n4. History of corneal surgery.\n5. Currently pregnant or lactating.\n6. Systemic disease that would interfere with contact lens wear.\n7. Previous diagnosis of dry eye syndrome.'}, 'identificationModule': {'nctId': 'NCT04031118', 'briefTitle': 'Corneal Oxygen Uptake With Apioc Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lentechs, LLC'}, 'officialTitle': 'Corneal Oxygen Uptake With Apioc Contact Lenses', 'orgStudyIdInfo': {'id': 'Len-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Apioc Contact Lens', 'type': 'DEVICE', 'description': 'Measurement of corneal oxygen uptake with contact lens wear.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Rev1 Ventures', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lentechs, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}