Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-29 @ 2:33 AM
Study NCT ID:
NCT00870103
Status:
COMPLETED
Last Update Posted:
2010-03-09
First Post:
2008-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'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'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '888.451.3937; 817.568.6725', 'title': 'Alcon Clinical', 'organization': 'Alcon Research Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vigadexa Group', 'description': 'Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye', 'otherNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vigadexa Group', 'description': 'Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye'}], 'classes': [{'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15 after cataract surgery', 'description': 'The percentage of patients with a score of zero for Anterior chamber cells.\n\nAnterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm).\n\nAnterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Percentage of Patients With no Ocular Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vigadexa Group', 'description': 'Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye'}], 'classes': [{'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15 after cataract surgery', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vigadexa Group', 'description': 'Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '64 patients were enrolled into the study', 'preAssignmentDetails': 'Nonrandomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Vigadexa Group', 'description': 'Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'lastUpdateSubmitDate': '2010-03-03', 'studyFirstSubmitDate': '2008-09-26', 'resultsFirstSubmitDate': '2010-01-14', 'studyFirstSubmitQcDate': '2009-03-25', 'lastUpdatePostDateStruct': {'date': '2010-03-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-21', 'studyFirstPostDateStruct': {'date': '2009-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.', 'timeFrame': 'Day 15 after cataract surgery', 'description': 'The percentage of patients with a score of zero for Anterior chamber cells.\n\nAnterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm).\n\nAnterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon'}, {'measure': 'The Percentage of Patients With no Ocular Pain', 'timeFrame': 'Day 15 after cataract surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cataract'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≧18 years of age\n* able to sign an informed consent and complete all required visits\n* intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL)\n* Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg)\n\nExclusion Criteria:\n\n* Uncontrolled glaucoma or IOP\n* use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye\n* use of steroid during the study or within 14 days prior to enrollment'}, 'identificationModule': {'nctId': 'NCT00870103', 'briefTitle': 'Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'An Evaluation of the Prophylactic Efficacy and Safety of the Administration of the Combination Formulation of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops in Inflammation and Infection Post-cataract Surgery', 'orgStudyIdInfo': {'id': 'RM-08-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vigadexa eye drops', 'description': 'Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops', 'interventionNames': ['Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops']}], 'interventions': [{'name': 'Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops', 'type': 'DRUG', 'description': '1 drop every 6 hours into the study eye', 'armGroupLabels': ['Vigadexa eye drops']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Alcon Call Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Benny Li, Regional Scientific Clinical Affair Manager', 'oldOrganization': 'Alcon Research Ltd.'}}}}