Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT00690794
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2008-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069557', 'term': 'Travoprost'}, {'id': 'D000077338', 'term': 'Latanoprost'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '1-888-451-3937', 'title': 'Director of Alcon Clinical', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Alcon reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The subjective nature of the OSDI may not be sensitive enough to detect the effects of preservatives on the corneal surface. The measurement and quantification of OSD remains a considerable clinical challenge. (Pflugfelder and Baudoin, 2011)'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study: 03 July 2008 to 26 May 2009.', 'description': 'This reporting group includes all patients who received the test article.', 'eventGroups': [{'id': 'EG000', 'title': 'Travoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days', 'otherNumAtRisk': 363, 'otherNumAffected': 0, 'seriousNumAtRisk': 363, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Latanoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days', 'otherNumAtRisk': 363, 'otherNumAffected': 0, 'seriousNumAtRisk': 363, 'seriousNumAffected': 7}], 'seriousEvents': [{'term': 'Coronary Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Brachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Travoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days'}, {'id': 'OG001', 'title': 'Latanoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-11.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 90', 'description': "The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point score) used to measure ocular symptoms, visual function and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. An Observed Case analysis (OC) was performed for the ITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Corneal Fluorescein Staining Score = 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Travoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days'}, {'id': 'OG001', 'title': 'Latanoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': 'The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (\\>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by the total number of patients analyzed.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat. All patients who received test article and had at least one on-therapy study visit were evaluable for the intent-to-treat analysis. An Observed Case analysis (OC) was performed for the ITT population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Travoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days'}, {'id': 'FG001', 'title': 'Latanoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '363'}, {'groupId': 'FG001', 'numSubjects': '363'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '342'}, {'groupId': 'FG001', 'numSubjects': '328'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Patients were recruited from 70 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and on XALATAN® monotherapy for at least one month immediately prior to Visit 1 were enrolled.', 'preAssignmentDetails': '726 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received test article and had at least one on-therapy study visit (intent-to-treat): 678.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '678', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Travoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days'}, {'id': 'BG001', 'title': 'Latanoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.1', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '67.8', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '67.5', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 726}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-20', 'studyFirstSubmitDate': '2008-06-03', 'resultsFirstSubmitDate': '2012-03-30', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-31', 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score', 'timeFrame': 'Baseline, Day 90', 'description': "The OSDI is a 12-question validated questionnaire (resultant overall 0-100 point score) used to measure ocular symptoms, visual function and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 90-day OSDI score and reported as change. A negative number represents a perceived improvement in ocular health."}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Corneal Fluorescein Staining Score = 0', 'timeFrame': 'Day 90', 'description': 'The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (\\>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by the total number of patients analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Open-angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare two ophthalmic solutions 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 years or older.\n* Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.\n* Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.\n* Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.\n* Willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study, including artificial tears.\n* Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.\n* Use of contact lenses within 30 days of Visit 1.\n* Use of contact lenses during the study.\n* Participation in an investigational drug or device study within 30 days of entering this study.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00690794', 'briefTitle': 'Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution', 'orgStudyIdInfo': {'id': 'C-08-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Travoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days', 'interventionNames': ['Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Latanoprost', 'description': 'One drop self-administered in the study eye(s) once daily for 90 days', 'interventionNames': ['Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)']}], 'interventions': [{'name': 'Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)', 'type': 'DRUG', 'otherNames': ['TRAVATAN Z®'], 'description': 'Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost.', 'armGroupLabels': ['Travoprost']}, {'name': 'Latanoprost ophthalmic solution 0.005% (XALATAN®)', 'type': 'DRUG', 'otherNames': ['XALATAN®'], 'description': 'Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanprost.', 'armGroupLabels': ['Latanoprost']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}