Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-03 @ 11:10 PM
Study NCT ID:
NCT03861728
Status:
TERMINATED
Last Update Posted:
2021-12-29
First Post:
2018-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Viral Conjunctivitis Treatment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003236', 'term': 'Conjunctivitis, Viral'}], 'ancestors': [{'id': 'D015828', 'term': 'Eye Infections, Viral'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wlee@miami.edu', 'phone': '305-326-6434', 'title': 'Wendy Lee', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination led to small numbers of subjects analyzed'}}, 'adverseEventsModule': {'timeFrame': '3 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Viral Conjunctivitis Treatment', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid\n\n0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Viral Conjunctivitis Placebo', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline\n\nPlacebo: Placebo to be used four times a day to the affected eye for 2 weeks', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'HSV Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Resolution of Viral Conjunctivitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Viral Conjunctivitis Treatment', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid\n\n0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)'}, {'id': 'OG001', 'title': 'Viral Conjunctivitis Placebo', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline\n\nPlacebo: Placebo to be used four times a day to the affected eye for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 days', 'description': 'This is the number of participants who on day 7 (+/-1 days) had on clinical examination a 0 or 1 on the follicular conjunctivitis scale and 0 or 1 on the conjunctival injection scale.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment or placebo and returned for follow up.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Symptomatic Resolution of Viral Conjunctivitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Viral Conjunctivitis Treatment', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid\n\n0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)'}, {'id': 'OG001', 'title': 'Viral Conjunctivitis Placebo', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline\n\nPlacebo: Placebo to be used four times a day to the affected eye for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 days', 'description': 'This is the number of participants who on day 7 (+/-1 days) answered on clinical questionaire "none" or "mild" to each of the following list of 7 symptoms: "overall symptoms that affect your daily activities", "itching", "tearing", "pain", "feeling that your lids are stuck together in the morning", "sensitivity to light", "blurry vision"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment or placebo and returned for follow up.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Undetectable Adenoviral DNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Viral Conjunctivitis Treatment', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid\n\n0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)'}, {'id': 'OG001', 'title': 'Viral Conjunctivitis Placebo', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline\n\nPlacebo: Placebo to be used four times a day to the affected eye for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 days', 'description': 'This is the number of participants who on day 7 (+/-1 days) had undetectable adenoviral DNA by quantitative Polymerase Chain Reaction (qPCR) (Ct \\> 35)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment or placebo and returned for follow up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Viral Conjunctivitis Treatment', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid\n\n0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)'}, {'id': 'FG001', 'title': 'Viral Conjunctivitis Placebo', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline\n\nPlacebo: Placebo to be used four times a day to the affected eye for 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Viral Conjunctivitis Treatment', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid\n\n0.01% Hypochlorous acid: Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)'}, {'id': 'BG001', 'title': 'Viral Conjunctivitis Placebo', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline\n\nPlacebo: Placebo to be used four times a day to the affected eye for 2 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '74'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '56'}, {'value': '40', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Symptoms Prior to Presentation', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'All participants who received at least one dose of treatment or placebo and returned for follow up.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-29', 'size': 213922, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-29T11:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'A second investigator will randomize the patient to Treatment vs Placebo on initial visit. This "second investigator" will not be involved in screening or follow-up patient visits. At the end of the study the patient arms will be unmasked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'COVID-19 Pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2021-07-20', 'completionDateStruct': {'date': '2020-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-29', 'studyFirstSubmitDate': '2018-12-11', 'dispFirstSubmitQcDate': '2021-07-20', 'resultsFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2019-02-28', 'dispFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-29', 'studyFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Resolution of Viral Conjunctivitis', 'timeFrame': 'Up to 8 days', 'description': 'This is the number of participants who on day 7 (+/-1 days) had on clinical examination a 0 or 1 on the follicular conjunctivitis scale and 0 or 1 on the conjunctival injection scale.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Symptomatic Resolution of Viral Conjunctivitis', 'timeFrame': 'Up to 8 days', 'description': 'This is the number of participants who on day 7 (+/-1 days) answered on clinical questionaire "none" or "mild" to each of the following list of 7 symptoms: "overall symptoms that affect your daily activities", "itching", "tearing", "pain", "feeling that your lids are stuck together in the morning", "sensitivity to light", "blurry vision"'}, {'measure': 'Number of Participants With Undetectable Adenoviral DNA', 'timeFrame': 'Up to 8 days', 'description': 'This is the number of participants who on day 7 (+/-1 days) had undetectable adenoviral DNA by quantitative Polymerase Chain Reaction (qPCR) (Ct \\> 35)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Viral Conjunctivitis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Debabov D, Noorbakhsh C, Wang L, et al. Avenova™ with Neutrox™ (pure 0.01% HOCl) compared with OTC product (0.02% HOCl). NovaBay Pharmaceuticals, Inc., Emeryville, California, USA'}, {'pmid': '18677274', 'type': 'RESULT', 'citation': 'Kim HJ, Lee JG, Kang JW, Cho HJ, Kim HS, Byeon HK, Yoon JH. Effects of a low concentration hypochlorous Acid nasal irrigation solution on bacteria, fungi, and virus. Laryngoscope. 2008 Oct;118(10):1862-7. doi: 10.1097/MLG.0b013e31817f4d34.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the efficacy Avenova® (0.01% hypochlorous acid) in the treatment of viral conjunctivitis. The investigators hypothesize that patients treated with Avenova® will have a quicker resolution of their ocular signs and symptoms of Viral Conjunctivitis compared with artificial tears.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting to the Bascom Palmer Eye Institute\n* Clinical diagnosis of viral conjunctivitis\n* Symptoms less than 1 week duration\n\nExclusion Criteria:\n\n* history of allergic conjunctivitis\n* history of herpetic eye disease\n* concurrent diagnosis of bacterial conjunctivitis (based off microbiology plating)\n* Immunocompromised / Immunosuppressed patients\n* Patients with HIV\n* pregnant women\n* prisoners\n* adults who are unable to provide consent'}, 'identificationModule': {'nctId': 'NCT03861728', 'briefTitle': 'Viral Conjunctivitis Treatment Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Avenova for the Treatment of Viral Conjunctivitis', 'orgStudyIdInfo': {'id': '20170064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Viral Conjunctivitis Treatment', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with 0.01% Hypochlorous acid', 'interventionNames': ['Device: 0.01% Hypochlorous acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Viral Conjunctivitis Placebo', 'description': 'Patients with viral conjunctivitis as defined by a + AdenoPlus test and clinical symptoms and signs of viral conjunctivitis who will be treated with Basic Sterile Saline', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': '0.01% Hypochlorous acid', 'type': 'DEVICE', 'otherNames': ['Avenova'], 'description': 'Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)', 'armGroupLabels': ['Viral Conjunctivitis Treatment']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Basic Sterile Saline'], 'description': 'Placebo to be used four times a day to the affected eye for 2 weeks', 'armGroupLabels': ['Viral Conjunctivitis Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Bascom Palmer Eye Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Wendy Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bascom Palmer Eye Institute, University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'NovaBay Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Wendy Lee', 'investigatorAffiliation': 'University of Miami'}}}}