Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 5:51 AM
Study NCT ID:
NCT00798759
Status:
COMPLETED
Last Update Posted:
2012-06-01
First Post:
2008-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN
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: 22 December 2008 to 20 May 2009.', 'description': 'This reporting group includes all patients who received test article.', 'eventGroups': [{'id': 'EG000', 'title': 'Travoprost', 'description': 'One drop self administered in the study eye(s) once daily at night for 12 weeks', 'otherNumAtRisk': 117, 'otherNumAffected': 7, 'seriousNumAtRisk': 117, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Latanoprost', 'description': 'One drop self administered in the study eye(s) once daily at night for 12 weeks', 'otherNumAtRisk': 119, 'otherNumAffected': 3, 'seriousNumAtRisk': 119, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MeDRA 11.0'}], 'seriousEvents': [{'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MeDRA 11.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MeDRA 11.0'}, {'term': 'Coronary Arterial Stent Insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MeDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Travoprost', 'description': 'One drop self administered in the study eye(s) once daily at night for 12 weeks'}, {'id': 'OG001', 'title': 'Latanoprost', 'description': 'One drop self administered in the study eye(s) once daily at night for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, Day 84', 'description': "Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.", 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: All patients who received test article and completed the trial.'}, {'type': 'SECONDARY', 'title': 'Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Travoprost', 'description': 'One drop self administered in the study eye(s) once daily at night for 12 weeks'}, {'id': 'OG001', 'title': 'Latanoprost', 'description': 'One drop self administered in the study eye(s) once daily at night for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0, Day 84', 'description': "The OSDI is a 12-question validated questionnaire (resultant overall 0-100 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 12-week 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 completed the trial.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Travoprost', 'description': 'One drop self-administered in the study eye(s) once daily at night for 12 weeks'}, {'id': 'FG001', 'title': 'Latanoprost', 'description': 'One drop self-administered in the study eye(s) once daily at night for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were recruited from 22 US study centers. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension and on XALATAN® monotherapy for six months prior to Visit 1 were enrolled.', 'preAssignmentDetails': '236 patients were enrolled in the study and evaluated for safety. Baseline characteristics are presented for all patients who received test article and completed the study (intent-to-treat): 215.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Travoprost', 'description': 'One drop self-administered in the study eye(s) once daily at night for 12 weeks'}, {'id': 'BG001', 'title': 'Latanoprost', 'description': 'One drop self-administered in the study eye(s) once daily at night for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.3', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '69.0', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '67.6', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '78', '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': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-25', 'studyFirstSubmitDate': '2008-11-24', 'resultsFirstSubmitDate': '2012-03-30', 'studyFirstSubmitQcDate': '2008-11-25', 'lastUpdatePostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-30', 'studyFirstPostDateStruct': {'date': '2008-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break-Up Time (TFBUT)', 'timeFrame': 'Day 0, Day 84', 'description': "Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time."}], 'secondaryOutcomes': [{'measure': 'Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score', 'timeFrame': 'Day 0, Day 84', 'description': "The OSDI is a 12-question validated questionnaire (resultant overall 0-100 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 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open-angle glaucoma', 'Ocular hypertension'], 'conditions': ['Open-angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this 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* Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.\n* Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.\n* Best corrected visual acuity of -0.6 logMAR or better in each eye.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Treatment with BAK preserved artificial tears within 30 days of Visit 1.\n* Known or suspected Sjogren's disease.\n* Uncontrolled IOP.\n* History or evidence of infectious or inflammatory ocular conditions.\n* Progressive retinal or optic nerve disease.\n* Ocular laser surgery within 3 months of Visit 1.\n* Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1.\n* Current use of punctal plugs or punctal cautery.\n* Use of systemic medications that has not been stable for 30 days prior to Visit 1.\n* Use of contact lens within 30 days of Visit 1.\n* Other protocol-defined exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT00798759', 'briefTitle': 'Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and XALATAN®', 'orgStudyIdInfo': {'id': 'C-08-050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Travoprost', 'description': 'One drop self-administered in the study eye(s) once daily at night for 12 weeks', '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 at night for 12 weeks', '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 12 weeks (84 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 12 weeks (84 days). Referred to as latanoprost.', 'armGroupLabels': ['Latanoprost']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}