Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 5:29 PM
Study NCT ID:
NCT00767494
Status:
TERMINATED
Last Update Posted:
2012-09-19
First Post:
2008-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069557', 'term': 'Travoprost'}, {'id': 'C111827', 'term': 'brinzolamide'}], 'ancestors': [{'id': 'D003008', 'term': 'Cloprostenol'}, {'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Project Cancelled', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-18', 'studyFirstSubmitDate': '2008-10-03', 'studyFirstSubmitQcDate': '2008-10-06', 'lastUpdatePostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean IOP', 'timeFrame': '9, 11, and 16:00 time points at Week 12'}], 'secondaryOutcomes': [{'measure': 'Mean diurnal IOP at Week 12', 'timeFrame': 'results pooled across 9,11, and 16:00 time points'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['OAG', 'OH', 'Open-angle glaucoma or ocular hypertension'], 'conditions': ['Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the IOP lowering efficacy of Travoprost/Brinzolamide dosed daily in the morning or evening, vs TRAVATAN dosed once daily in the evening, and vs. AZOPT dosed BID in patients with open-angle glaucoma or ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 YOA or older\n* Either gender or any race\n* OAG or OHT\n* Currently on stable (at least 4 weeks) IOP lowering medication\n* IOP at screening visit ≥ 18mmHg in at least one eye\n* Mean IOP in same eye (at both eligibility 1\\&2 visits\n* 24 and 36 mmHg at 9AM\n* 21 and 36 mmHg at 11AM and 4PM\n* Able to discontinue use of IOP lowering medication for a minimum wash out period of 5 to 28 days prior to eligibility visit 1\n\nExclusion Criteria:\n\nRelated to disease condition being investigated (OAG or OHT) in either eye\n\n* Severe central visual field loss\n* Angle shaffer grade \\< 2\n* C/D ratio \\>0.8(horizontal or vertical measurement)\n\nRelated to ocular patient history or current ocular condition in either eye\n\n* BSCVA worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)\n* Ocular infection or inflammation or laser surgery within the last 3 months\n* Intraocular surgery or trauma with the last 6 months\n* Any abnormality preventing reliable applanation tonometry\n* History or chronic, recurrently or current severe inflammatory disease\n* History of or current clinically significant or progressive retinal disease\n* History of or current ocular pathology(including severe dry eye) that would affect the conduct of the study\n\nRelated to systemic or ocular medication in either eye\n\n* Allergy/hypersensitivity to study medications\n* Unable to discontinue glucocorticoid at least 4 weeks prior to the study or unable to remain off these medications during the study period\n* Use of oral CAIs during the study\n* Recent use (\\<4 weeks prior to the study) of Aspirin (\\>1 gram)\n* Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP\n* Therapy with another investigational agent within 30 days prior to the Screening Visit'}, 'identificationModule': {'nctId': 'NCT00767494', 'briefTitle': 'Travoprost/Brinzolamide Fixed Combination Versus Travatan and Versus AZOPT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-07-63'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Travoprost/Brinzolamide AM, Vehicle PM', 'interventionNames': ['Drug: Travoprost/Brinzolamide fixed combination']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Travoprost/Brinzolamide PM, Vehicle AM', 'interventionNames': ['Drug: Travoprost/Brinzolamide fixed combination']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'AZOPT AM and PM', 'interventionNames': ['Drug: Azopt']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'TRAVATAN PM, Vehicle AM', 'interventionNames': ['Drug: Travatan']}], 'interventions': [{'name': 'Travoprost/Brinzolamide fixed combination', 'type': 'DRUG', 'description': 'Eye Drops, suspension once daily', 'armGroupLabels': ['1', '2']}, {'name': 'Azopt', 'type': 'DRUG', 'description': 'Eye Drop Suspension, 1 drop BID', 'armGroupLabels': ['3']}, {'name': 'Travatan', 'type': 'DRUG', 'description': 'Eye Drop Solution, 1 drop BID', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}