Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT00332293
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2006-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AL-15469A for the Treatment of Bacterial Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003234', 'term': 'Conjunctivitis, Bacterial'}], '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': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 695}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2006-05-31', 'studyFirstSubmitQcDate': '2006-05-31', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical cure and microbiological success'}], 'secondaryOutcomes': [{'measure': 'Individual signs and symptoms of bacterial conjunctivitis at each visit'}]}, 'conditionsModule': {'conditions': ['Bacterial Conjunctivitis']}, 'referencesModule': {'references': [{'pmid': '21681652', 'type': 'RESULT', 'citation': 'Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011 Jul;28(7):566-74. doi: 10.1007/s12325-011-0037-x. Epub 2011 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signs and symptoms of bacterial conjunctivitis\n* Other protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* under 1 mo. age\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00332293', 'briefTitle': 'AL-15469A for the Treatment of Bacterial Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in India', 'orgStudyIdInfo': {'id': 'C-04-40'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moxifloxacin', 'interventionNames': ['Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VIGAMOX', 'interventionNames': ['Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base']}], 'interventions': [{'name': 'Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%', 'type': 'DRUG', 'description': '1 drop into the conjunctival sac of both eyes 3 times a day for 3 days', 'armGroupLabels': ['Moxifloxacin']}, {'name': 'Moxifloxacin hydrochloride ophthalmic solution 0.5% as base', 'type': 'DRUG', 'otherNames': ['VIGAMOX'], 'description': '1 drop into the conjunctival sac of both eyes 3 times a day for 3 days', 'armGroupLabels': ['VIGAMOX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}