Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-28 @ 3:48 PM
Study NCT ID:
NCT02138461
Status:
COMPLETED
Last Update Posted:
2014-09-25
First Post:
2014-05-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jhovanesian@mdbackline.com', 'phone': '949 951 9248', 'title': 'John A. Hovanesian, MD', 'organization': 'MDbackline, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bimatoprost', 'description': 'These patients take bimatoprost topically for glaucoma.', 'otherNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Latanoprost Group', 'description': 'These patients take latanoprost topically for glaucoma.', 'otherNumAtRisk': 110, 'otherNumAffected': 0, 'seriousNumAtRisk': 110, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tolerability of Medications as Measured by the COMTOL Validated Instrument', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bimatoprost', 'description': 'These patients take bimatoprost topically for glaucoma.'}, {'id': 'OG001', 'title': 'Latanoprost Group', 'description': 'These patients take latanoprost topically for glaucoma.'}], 'classes': [{'title': 'Bothered by Itching More than "A Little"', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Bothered by Burning/Stinging More Than "A Little"', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Bothered by Redness More Than "A Little"', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}, {'title': 'Bothered by Dry Eyes More Than "A Little"', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study', 'description': 'Patients who are already taking the medications of interest will be enrolled from a general ophthalmology practice. Immediately after consenting to participate, they will complete a validated survey instrument called the Comparison of Ophthalmic Medication for Primary Outcome Measure Tolerability (COMTOL) questionnaire (Ophthalmology 1997; : 104:334-342). Because this study will not be a crossover trial design, and patients will only continue taking the medications they were prescribed in the course of their glaucoma therapy, the modified version will eliminate questions in the COMTOL related to subjective comparison of two medications and instead focus on tolerability of the single medication being taken by test subjects.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bimatoprost', 'description': 'These patients take bimatoprost topically for glaucoma.'}, {'id': 'FG001', 'title': 'Latanoprost Group', 'description': 'These patients take latanoprost topically for glaucoma.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bimatoprost', 'description': 'These patients take bimatoprost topically for glaucoma.'}, {'id': 'BG001', 'title': 'Latanoprost Group', 'description': 'These patients take latanoprost topically for glaucoma.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '73.4', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '74.4', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': "Note patients will be recruited to fill out a questionnaire, describing their symptoms related to glaucoma use drops. In this study, we are examining only patients taking either bimatoprost or latanoprost, thus 2 cohorts. However, this is not an interventional study, and there will be only one study visit (enrollment and questionnaire at the same time) and no change in the patient's prescribed therapy."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-16', 'studyFirstSubmitDate': '2014-05-09', 'resultsFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-16', 'studyFirstPostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability of Medications as Measured by the COMTOL Validated Instrument', 'timeFrame': 'at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study', 'description': 'Patients who are already taking the medications of interest will be enrolled from a general ophthalmology practice. Immediately after consenting to participate, they will complete a validated survey instrument called the Comparison of Ophthalmic Medication for Primary Outcome Measure Tolerability (COMTOL) questionnaire (Ophthalmology 1997; : 104:334-342). Because this study will not be a crossover trial design, and patients will only continue taking the medications they were prescribed in the course of their glaucoma therapy, the modified version will eliminate questions in the COMTOL related to subjective comparison of two medications and instead focus on tolerability of the single medication being taken by test subjects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma', 'bimatoprost', 'latanoprost', 'tolerability'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'This study examines patient perceptions regarding the tolerability of two classes of glaucoma medication: bimatoprost and latanoprost.', 'detailedDescription': 'Patients enrolled in this study completed a validated survey instrument (COMTOL) examining tolerability of topically applied ophthalmic medications that they are already taking in their regular course of care for glaucoma. The purpose of the study is to determine whether side effects and symptoms of the drugs already being taken cause problems with activities of daily living.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients taking either study medication for glaucoma.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with glaucoma taking either bimatoprost or latanoprost\n\nExclusion Criteria:\n\n* patients taking other medication or with other causes for ocular surface symptoms'}, 'identificationModule': {'nctId': 'NCT02138461', 'briefTitle': 'Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops', 'organization': {'class': 'OTHER', 'fullName': 'MDbackline, LLC'}, 'officialTitle': 'Subjective Patient Assessment Comparing Overall Tolerability and Satisfaction of a Prostaglandin Analogue Including Either Bimatoprost 0.01% or Latanoprost.', 'orgStudyIdInfo': {'id': 'JH-ALG-MDB-1301'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bimatoprost', 'description': 'These patients take bimatoprost topically for glaucoma.'}, {'label': 'latanoprost group', 'description': 'These patients take latanoprost topically for glaucoma.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Harvard Eye Associates', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}], 'overallOfficials': [{'name': 'John A. Hovanesian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA Jules Stein Eye Institute'}, {'name': 'Savak Teymoorian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard Eye Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MDbackline, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}