Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-28 @ 9:34 PM
Study NCT ID:
NCT01313351
Status:
COMPLETED
Last Update Posted:
2022-12-12
First Post:
2011-03-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rob.sambursky@lumosdiagnostics.com', 'phone': '9415581853', 'title': 'Robert Sambursky, MD', 'organization': 'Rapid Pathogen Screening, Inc'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '15 minutes', 'description': 'Regular monitoring by sponsor and mandatory reporting by investigator', 'eventGroups': [{'id': 'EG000', 'title': 'Device Testing', 'description': 'As reported by user', 'otherNumAtRisk': 206, 'otherNumAffected': 0, 'seriousNumAtRisk': 206, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'InflammaDry Sensitivity', 'description': 'Percentage of True Positives when compared to Clinical Assessment'}, {'id': 'OG001', 'title': 'InflammaDry Specificity', 'description': 'Percentage of True Negatives when compared to Clinical Assessment'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '77.6', 'upperLimit': '90.5'}, {'value': '94', 'groupId': 'OG001', 'lowerLimit': '84.5', 'upperLimit': '98.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes', 'description': 'Patients were assessed for signs and Symptoms of Dry Eye using OSDI (Ocular Surface Disease Index), TBUT (Fluorescein Tear Break-up Time), Corneal fluorescein staining and Schirmer Tear Test and compared to the results of the tested device.\n\nSensitivity is the percentage of true positive cases correctly identified by the test, compared to clinical assessment.\n\nSpecificity is the percentage of true negative cases correctly identified by the test, compared to clinical assessment.', 'unitOfMeasure': 'percentage of cases', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Device Testing', 'description': 'Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated.\n\nRPS InflammaDry Detector™: A noninvasive immunoassay for detecting MMP-9 levels in tears'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'InflammaDry Test', 'description': 'Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated.\n\nRPS InflammaDry Detector™: A noninvasive immunoassay for detecting MMP-9 levels in tears'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '152', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '136', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '206', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-11', 'studyFirstSubmitDate': '2011-03-03', 'resultsFirstSubmitDate': '2021-11-01', 'studyFirstSubmitQcDate': '2011-03-08', 'lastUpdatePostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-11', 'studyFirstPostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes.', 'timeFrame': '15 minutes', 'description': 'Patients were assessed for signs and Symptoms of Dry Eye using OSDI (Ocular Surface Disease Index), TBUT (Fluorescein Tear Break-up Time), Corneal fluorescein staining and Schirmer Tear Test and compared to the results of the tested device.\n\nSensitivity is the percentage of true positive cases correctly identified by the test, compared to clinical assessment.\n\nSpecificity is the percentage of true negative cases correctly identified by the test, compared to clinical assessment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dry eyes', 'Dysfunctional tear syndrome'], 'conditions': ['Dry Eye']}, 'referencesModule': {'references': [{'pmid': '23307206', 'type': 'DERIVED', 'citation': 'Sambursky R, Davitt WF 3rd, Latkany R, Tauber S, Starr C, Friedberg M, Dirks MS, McDonald M. Sensitivity and specificity of a point-of-care matrix metalloproteinase 9 immunoassay for diagnosing inflammation related to dry eye. JAMA Ophthalmol. 2013 Jan;131(1):24-8. doi: 10.1001/jamaophthalmol.2013.561.'}]}, 'descriptionModule': {'briefSummary': 'The RPS InflammaDry Detector™ is intended to detect elevated MMP-9 in human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.', 'detailedDescription': 'The purpose of this clinical trial was to determine the sensitivity and specificity of InflammaDry compared with the clinical assessment of dry eyes.\n\nPatients were screened using clinical history and signs.\n\nClinical history was performed using the Ocular Surface Disease Index (OSDI) and evaluated for clinical signs:\n\n* positive vital staining of the ocular surface,\n* decreased tear breakup time (TBUT),\n* reduced corneal sensitivity, and\n* decreased functional visual acuity Last, an independent health care professional masked to the clinical evaluation was asked to analyze each InflammaDry test result, independently confirming each result.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Only patients who met the inclusion criteria were included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': "INCLUSION CRITERIA\n\nPatients older than 18 years of age, who meet the following criteria related to the clinical history and signs will be enrolled:\n\nGroup 1: Clinical Dry Eyes\n\nClinical History Criteria\n\nAn Ocular Surface Disease Index (OSDI) of greater than or equal to 13 - \\[Appendix #2\\]\n\nClinical Signs Criteria - All of the following must be present\n\n1. Schirmer's Tear Test (with anesthesia) \\< 10 mm over 5 minutes\n2. Tear Film Break Up Time (TBUT) \\< 10 seconds\n3. Total Corneal Staining ≥ 1 \\[Appendix #1\\]\n\n * At least 1/2 of all patients enrolled will have a Schirmer's Tear Test \\< 5 mm or demonstrate corneal staining ≥ 2 \\[Appendix #1\\]\n\nGroup 2: Clinical Normal Non-Dry Eyes\n\nClinical History Criteria\n\nAn Ocular Surface Disease Index (OSDI) of \\< 7 - \\[Appendix #2\\]\n\nClinical Signs Criteria - All 3 of the following must be present\n\n1. Schirmer's Tear Test (with anesthesia) ≥ 10 mm over 5 minutes\n2. Tear Film Break Up Time (TBUT) ≥ 10 seconds\n3. Total Corneal Staining = 0 \\[Appendix #1\\]\n\nEXCLUSION CRITERIA\n\n* Patients with allergy to corn starch, talcum powder, or dacron\n* Patients with prior eye injury, trauma, or ocular surgery within the previous 3 months\n* Patients with non-dry eye ocular inflammation, uveitis, history of herpetic keratitis or zoster keratitis\n* Patients with history of a recent ocular infection within the prior 1 month\n* Use of oral doxycycline or topical macrolides (AzaSite) within 1 month\n* Patients currently receiving, or received in the last 2 weeks of the study , certain medications including topical or systemic corticosteroids, topical or systemic Nonsteroidal (NSAIDs) therapy, topical cyclosporine, or other immunosuppressive therapy\n* Patients who are pregnant or lactating\n* Before initialization of the study, patients must not have used any topical medications, including artificial tears during the previous 2 hours\n* The use of Rigid-Gas permeable contact lenses or the use of soft-contact lenses within 1 month of the study"}, 'identificationModule': {'nctId': 'NCT01313351', 'briefTitle': 'RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumos Diagnostics'}, 'officialTitle': "A Clinical Evaluation of the RPS InflammaDry Detector's Sensitivity and Specificity Compared to the Clinical Diagnosis for Confirming Dry Eyes.", 'orgStudyIdInfo': {'id': '100310'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Device testing', 'description': 'Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated.', 'interventionNames': ['Device: RPS InflammaDry Detector™']}], 'interventions': [{'name': 'RPS InflammaDry Detector™', 'type': 'DEVICE', 'description': 'A noninvasive immunoassay for detecting MMP-9 levels in tears', 'armGroupLabels': ['Device testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Manatee Sarasota Eye Clinic', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Excellence in Eye Care', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Clinics", 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '11563', 'city': 'Lynbrook', 'state': 'New York', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Long Island', 'geoPoint': {'lat': 40.65483, 'lon': -73.6718}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Physician Eyecare of NY', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill-Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Black Hills Regional Eye Institute', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '79904-2037', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'William F. Davitt, III, MD', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}], 'overallOfficials': [{'name': 'Robert Sambursky, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rapid Pathogen Screening, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rapid Pathogen Screening', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}