Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 9:56 PM
Study NCT ID:
NCT00763061
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2008-09-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069557', 'term': 'Travoprost'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D013999', 'term': 'Timolol'}], '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'}, {'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'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}]}}, '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': 'Travoprost 0.004%', 'description': 'Travoprost at 9 AM + Placebo \\& 9 PM', 'otherNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Timolol 0.5%', 'description': 'Timolol in each eye, twice daily at 9 AM \\& 9 PM', 'otherNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Intraocular Pressure (IOP) at 9 AM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Travoprost 0.004%', 'description': 'Travoprost at 9 AM + Placebo \\& 9 PM'}, {'id': 'OG001', 'title': 'Timolol 0.5%', 'description': 'Timolol in each eye, twice daily at 9 AM \\& 9 PM'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '4.27', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '4.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "At Week 12 - At the 9 AM time point for the patient's worse eye.", 'description': 'Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.', 'unitOfMeasure': 'millimeters mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean IOP Change From Baseline at 9 AM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Travoprost 0.004%', 'description': 'Travoprost at 9 AM + Placebo \\& 9 PM'}, {'id': 'OG001', 'title': 'Timolol 0.5%', 'description': 'Timolol in each eye, twice daily at 9 AM \\& 9 PM'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.1', 'spread': '4.35', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '4.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12 - at 9 AM', 'description': 'Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Week 12 - Mean IOP At 4 PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Travoprost 0.004%', 'description': 'Travoprost at 9 AM + Placebo \\& 9 PM'}, {'id': 'OG001', 'title': 'Timolol 0.5%', 'description': 'Timolol in each eye, twice daily at 9 AM \\& 9 PM'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '4.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': "At the 4 PM time point for the patient's worse eye.", 'description': 'Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean IOP Change at 4 PM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Travoprost 0.004%', 'description': 'Travoprost at 9 AM + Placebo \\& 9 PM'}, {'id': 'OG001', 'title': 'Timolol 0.5%', 'description': 'Timolol in each eye, twice daily at 9 AM \\& 9 PM'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '4.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12 - at 4 PM', 'description': 'Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Travoprost 0.004%', 'description': 'Travoprost at 9 AM + Placebo \\& 9 PM'}, {'id': 'FG001', 'title': 'Timolol 0.5%', 'description': 'Timolol in each eye, twice daily at 9 AM \\& 9 PM'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'recruitmentDetails': '111 patients were enrolled in this study at 4 hospitals', 'preAssignmentDetails': 'Eligibility patients were washed out for up to 4 weeks before randomization'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Travoprost 0.004%', 'description': 'Travoprost at 9 AM + Placebo \\& 9 PM'}, {'id': 'BG001', 'title': 'Timolol 0.5%', 'description': 'Timolol in each eye, twice daily at 9 AM \\& 9 PM'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-23', 'studyFirstSubmitDate': '2008-09-26', 'resultsFirstSubmitDate': '2009-04-28', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-12-21', 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Intraocular Pressure (IOP) at 9 AM', 'timeFrame': "At Week 12 - At the 9 AM time point for the patient's worse eye.", 'description': 'Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.'}, {'measure': 'Week 12 - Mean IOP At 4 PM', 'timeFrame': "At the 4 PM time point for the patient's worse eye.", 'description': 'Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.'}], 'secondaryOutcomes': [{'measure': 'Mean IOP Change From Baseline at 9 AM', 'timeFrame': 'Baseline to Week 12 - at 9 AM', 'description': 'Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.'}, {'measure': 'Mean IOP Change at 4 PM', 'timeFrame': 'Baseline to Week 12 - at 4 PM', 'description': 'Bilateral IOP measurements by Goldmann applanation were performed at 9AM and 4 PM. Two IOP measurements were taken and averaged. If the difference between the first and second reading was greater than 4 mmHg, a third reading was taken and the two nearest readings averaged.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.', 'detailedDescription': 'To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years;\n* IOP=16-30mmHg\n* OH or OAG with visual filed abnormality:\n\n 1. ≥3 adjacent points in 24 degrees field on the same side of the horizontal meridian, that have p \\<5% on the prepapillary diameter plot, one of which must have p \\<1%,\n 2. Glaucoma Hemifield Test outside normal limits,\n 3. Corrected Pattern Standard Deviation with p \\<5%\n\nExclusion Criteria:\n\n* Previous damage of anterior chamber angle;\n* ocular inflammation or ocular surgery within the past 3 months; Best Corrected Visual Acuity (logMAR) \\<1.0;\n* contact lens wearer;\n* severe central field loss;\n* uncontrolled cardiovascular, hepatic or renal disease;\n* any medication within past 1 month.'}, 'identificationModule': {'nctId': 'NCT00763061', 'briefTitle': 'Travatan Versus Timoptic in Treating Open-angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'A Twelve-Week, Double Masked, Parallel Group, Study of Travoprost 0.004% Compared to Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'MS-06-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Travoprost 0.004%', 'description': 'Travoprost 0.004%', 'interventionNames': ['Drug: Travoprost 0.004% Ophthalmic Solution (Travatan)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol 0.5%', 'description': 'Timolol 0.5%', 'interventionNames': ['Drug: Timolol 0.5% Ophthalmic Solution (Timoptic)']}], 'interventions': [{'name': 'Travoprost 0.004% Ophthalmic Solution (Travatan)', 'type': 'DRUG', 'description': 'Travoprost at 9 AM + Placebo \\& 9 PM', 'armGroupLabels': ['Travoprost 0.004%']}, {'name': 'Timolol 0.5% Ophthalmic Solution (Timoptic)', 'type': 'DRUG', 'description': 'Timolol in each eye, twice daily at 9 AM \\& 9 PM', 'armGroupLabels': ['Timolol 0.5%']}]}, '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, Ph.D.', 'oldOrganization': 'Alcon Research Ltd'}}}}