Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT01877694
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2013-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003234', 'term': 'Conjunctivitis, Bacterial'}, {'id': 'D003231', 'term': 'Conjunctivitis'}], 'ancestors': [{'id': 'D015818', 'term': 'Eye Infections, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C560851', 'term': 'NVC-422'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2013-06-07', 'studyFirstSubmitQcDate': '2013-06-11', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Resolution of individual ocular signs and symptoms', 'timeFrame': '5 days'}], 'primaryOutcomes': [{'measure': 'Microbiological Success', 'timeFrame': '5 days', 'description': 'Eradication of all pre-therapy isolates'}], 'secondaryOutcomes': [{'measure': 'Clinical Cure', 'timeFrame': '5 days', 'description': 'Resolution of all signs and symptoms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pink eye'], 'conditions': ['Bacterial Conjunctivitis']}, 'referencesModule': {'references': [{'pmid': '29602567', 'type': 'DERIVED', 'citation': 'Lee CS, Lee AY, Akileswaran L, Stroman D, Najafi-Tagol K, Kleiboeker S, Chodosh J, Magaret A, Wald A, Van Gelder RN; BAYnovation Study Group. Determinants of Outcomes of Adenoviral Keratoconjunctivitis. Ophthalmology. 2018 Sep;125(9):1344-1353. doi: 10.1016/j.ophtha.2018.02.016. Epub 2018 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the microbiological and clinical efficacy of Auriclosene compared to its vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either Auriclosene Ophthalmic Solution or Vehicle Ophthalmic Solution.', 'detailedDescription': 'This is a randomized (1:1) double-masked, vehicle-controlled, multi-center, parallel group study with two treatment arms: Auriclosene Ophthalmic Solution 0.3% ("Auriclosene") and Auriclosene Vehicle ("Vehicle").\n\nSubjects that meet all inclusion/exclusion criteria will be enrolled into the study, randomized and evaluated at 3 visits:\n\n* Visit 1: Screening, Day 1\n* Visit 2: Day 3 (±1)\n* Visit 3: Day 5 (+1) Test of Cure/Exit\n\nIP will be dosed OU (both eyes) QID for 4 days. Microbiological specimens will be collected from each eye at each visit.\n\nVisual Acuity will be assessed OU at each visit as well as rating of the ocular signs: lid erythema and swelling, bulbar and palpebralconjunctival injection, and conjunctival discharge/exudate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1 year of age and older\n* Bulbar conjunctival injection\n* Conjunctival discharge/exudate\n* Signs and symptoms of bacterial conjunctivitis in at least one eye for 3 days or less\n* Other inclusion criteria per protocol\n\nExclusion Criteria:\n\n* Suspected fungal, viral, Chlamydia or Acanthamoeba co-infection based on clinical diagnosis\n* Any drug treatment in either eye for the current episode of bacterial conjunctivitis prior to study enrollment\n* Other exclusion criteria per protocol'}, 'identificationModule': {'nctId': 'NCT01877694', 'acronym': 'BACTOvation™', 'briefTitle': 'Efficacy and Safety of Auriclosene (NVC-422) in the Treatment of Bacterial Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'NovaBay Pharmaceuticals, Inc.'}, 'officialTitle': 'A Multicenter, Randomized Study of the Efficacy and Safety of Auriclosene (NVC-422) Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis', 'orgStudyIdInfo': {'id': 'CL1301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Auriclosene Solution 0.3%', 'description': 'Dosed QID for 4 Days', 'interventionNames': ['Drug: Auriclosene Solution 0.3%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Auriclosene Vehicle', 'description': 'Dosed QID for 4 days', 'interventionNames': ['Drug: Auriclosene Vehicle']}], 'interventions': [{'name': 'Auriclosene Solution 0.3%', 'type': 'DRUG', 'otherNames': ['NVC-422'], 'description': 'Ophthalmic solution dispensed as drops onto the eye', 'armGroupLabels': ['Auriclosene Solution 0.3%']}, {'name': 'Auriclosene Vehicle', 'type': 'DRUG', 'description': 'Ophthalmic Vehicle solution dispensed as drops onto the eye', 'armGroupLabels': ['Auriclosene Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '30189', 'city': 'Woodstock', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.10149, 'lon': -84.51938}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '67114', 'city': 'Newton', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.04668, 'lon': -97.34504}}, {'zip': '08889', 'city': 'Whitehouse Station', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.61538, 'lon': -74.77044}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '27101', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45246', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45432', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '75110', 'city': 'Corsicana', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.09543, 'lon': -96.46887}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84015', 'city': 'Clinton', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 41.13967, 'lon': -112.0505}}, {'zip': '22902', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23113', 'city': 'Midlothian', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'David W. Stroman, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NovaBay Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NovaBay Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}