Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-03-06 @ 2:56 PM
Study NCT ID:
NCT03480906
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2018-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eyenovia MiDD Usability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077338', 'term': 'Latanoprost'}], 'ancestors': [{'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2018-03-13', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful microtherapeutic administration to the ocular surface', 'timeFrame': 'Treatment Day 3', 'description': 'Cumulative percent of cases in which microdose medication is delivered to the ocular surface as evaluated by the treating physician and an independent observer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraocular Pressure']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the usability and patient tolerability for microtherapeutic dosing of commercially available ocular medication via the Eyenovia microdose delivery system (MiDD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy patients without significant ocular pathology and mean unmedicated diurnal intraocular pressure (IOP) in the range of of 17-27 mmHg\n* Willing to forego use of contact lenses during study period\n* Presence of cognition an dexterity necessary to follow MiDD drug administration instructions\n* Female subjects must be 1-year postmenopausal, surgically sterilized, or if of childbearing potential, have a negative serum pregnancy test\n\nExclusion Criteria:\n\n* Prior clinically significant ocular history or abnormal eye exam\n* Use of ocular medication within 30 days of screening\n* Use of oral steroid within 30 days of screening, or anticipated need for ocular steroid treatment during study period\n* History of drug or alcohol abuse within 1 year of screening\n* Lid squeezer\n* Presence of disabling arthritis or limited motor coordination that would limit self-handling of the MiDD\n* Participation in any interventional study of an investigational drug or device within 30 days of screening'}, 'identificationModule': {'nctId': 'NCT03480906', 'briefTitle': 'Eyenovia MiDD Usability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eyenovia Inc.'}, 'officialTitle': 'An Evaluation of the Usability and Patient Tolerability for Microtherapeutic Dosing of Commercially Available Ocular Medication Via the Eyenovia Microdose Delivery System (MiDD)', 'orgStudyIdInfo': {'id': 'EYN-POC-PG-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microdose administration', 'description': 'Latanoprost ophthalmic solution administered as a microdose using the Eyenovia MiDD', 'interventionNames': ['Drug: Latanoprost']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Eyedrop administration', 'description': 'Latanoprost ophthalmic solution administered as an eyedrop', 'interventionNames': ['Drug: Latanoprost']}], 'interventions': [{'name': 'Latanoprost', 'type': 'DRUG', 'description': 'Latanoprost ophthalmic solution administered as a microdose spray', 'armGroupLabels': ['Microdose administration']}, {'name': 'Latanoprost', 'type': 'DRUG', 'description': 'Latanoprost ophthalmic solution administered as an eyedrop', 'armGroupLabels': ['Eyedrop administration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'country': 'Panama', 'facility': 'Clinica de Ojos Orillac-Calvo', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'Reuben Orillac, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica de Ojos Orillac-Calvo'}, {'name': 'Ernesto Calvo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinica de Ojos Orillac-Calvo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eyenovia Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}