Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-02 @ 10:06 AM
Study NCT ID:
NCT00527592
Status:
COMPLETED
Last Update Posted:
2012-05-18
First Post:
2007-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary 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': '1-800-862-5266', 'title': 'Director of Medical Affairs', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': "Sponsor does not guarantee the Investigator's right to publish study results since this is a pilot trial with results intended primarily for internal use. 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': 'None specified.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study and 14 days post study exit.', 'description': 'This reporting group includes all patients who received test article.', 'eventGroups': [{'id': 'EG000', 'title': 'Travoprost', 'description': 'One drop in the study eye, single dose', 'otherNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Latanoprost', 'description': 'One drop in the study eye, single dose', 'otherNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort Immediately After Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Travoprost', 'description': 'One drop in the study eye, single dose'}, {'id': 'OG001', 'title': 'Latanoprost', 'description': 'One drop in the study eye, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '16.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 seconds', 'description': 'Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Intent to treat: All patients who received test article and completed the trial.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Travoprost/Latanoprost', 'description': 'Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited from two US glaucoma specialty clinics from 6/8/2007 to 8/13/2008. Eligible patients having a diagnosis of open-angle glaucoma or ocular hypertension in both eyes were enrolled.', 'preAssignmentDetails': '54 patients were enrolled in the study. Qualified patients ceased prostaglandin use for 3-5 days (wash-out) prior to Visit 2 (randomization).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Travoprost/Latanoprost', 'description': 'Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', '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': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-11', 'studyFirstSubmitDate': '2007-09-10', 'resultsFirstSubmitDate': '2009-11-13', 'studyFirstSubmitQcDate': '2007-09-10', 'lastUpdatePostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-25', 'studyFirstPostDateStruct': {'date': '2007-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort Immediately After Dosing', 'timeFrame': '5 seconds', 'description': 'Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Comfort'], 'conditions': ['Open-Angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary 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 of age or older.\n* Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.\n* Best corrected visual acuity of 20/200 Snellen or better in each eye.\n* Intraocular pressure within protocol-specified range.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any abnormality preventing reliable applanation tonometry in the study eye(s).\n* Any eye conditions or procedures as specified in protocol.\n* Progressive retinal or optic nerve disease from any cause.\n* Use of contact lenses in the study eye(s).\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00527592', 'briefTitle': 'A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'SMA-07-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Travoprost', 'description': 'Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.', 'interventionNames': ['Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Latanoprost', 'description': 'Latanoprost assigned to one eye, with travoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.', '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, single dose. 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, single dose. Referred to as latanoprost.', 'armGroupLabels': ['Latanoprost']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}