Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-04 @ 4:55 AM
Study NCT ID:
NCT02167035
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2014-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mtepedino@wakehealth.edu', 'phone': '336-802-2255', 'title': 'Michael Tepedino, MD', 'organization': 'Cornerstone Healthcare'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor may request but cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The Local IRB closed in the middle of this trial which resulted in the discontinuation of 6 subjects. A new IRB was obtained and the study was re-opened and completed.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed from the time patients signed consent to their study exit, which was approximately 90 days for each patient.', 'description': 'Site utilized a systematic assessment of adverse events on this trial. Adverse events (AEs) were assessed at each study visit outlined on the protocol. Subjects were instructed to contact site to report any AEs between study visits. Unscheduled visits were conducted to assess these reported AEs between study visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Combigan BID', 'description': 'Combigan 0.2%/0.5% one drop BID\n\nCombigan BID', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 3, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Simbrinza TID', 'description': 'Simbrinza 1/0.2% one drop TID\n\nSimbrinza TID', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ocular Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-ocular Adverse Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combigan BID', 'description': 'Combigan 0.2%/0.5% one drop Twice Daily (BID)\n\nCombigan Twice Daily (BID)'}, {'id': 'OG001', 'title': 'Simbrinza TID', 'description': 'Simbrinza 1/0.2% one drop Three Times Daily (TID)\n\nSimbrinza Three Times Daily (TID)'}], 'classes': [{'title': 'Baseline 8am IOP', 'categories': [{'measurements': [{'value': '19.7', 'spread': '5.33', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '3.31', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 10am IOP', 'categories': [{'measurements': [{'value': '19.1', 'spread': '4.42', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '4.26', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 4pm IOP', 'categories': [{'measurements': [{'value': '17.6', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '3.83', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Diurnal IOP', 'categories': [{'measurements': [{'value': '18.8', 'spread': '4.42', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '3.53', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 8am IOP', 'categories': [{'measurements': [{'value': '17.6', 'spread': '4.47', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '2.26', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 10am IOP', 'categories': [{'measurements': [{'value': '17.6', 'spread': '3.08', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 4pm IOP', 'categories': [{'measurements': [{'value': '17.1', 'spread': '3.36', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '4.04', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 Diurnal IOP', 'categories': [{'measurements': [{'value': '17.4', 'spread': '3.12', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 8am IOP', 'categories': [{'measurements': [{'value': '18.7', 'spread': '4.19', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '3.44', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 10am IOP', 'categories': [{'measurements': [{'value': '17.7', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '3.96', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 4pm IOP', 'categories': [{'measurements': [{'value': '18.1', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '3.43', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 Diurnal IOP', 'categories': [{'measurements': [{'value': '18.1', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '18.0', 'spread': '3.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 (08:00, 10:00 16:00), Day 30 (08:00, 10:00, 16:00), Day 90 (08:00, 10:00,16:00)', 'description': 'The Intraocular Pressure will be assessed on study subjects. IOP (Intraocular Pressure) will be measured using a Goldmann applanation tonometer. Both eyes will be tested, with the right eye preceding the left eye. The operator will initially set the dial at 10 mmHg, then look through the slit lamp and adjust the dial to take the reading, and then record the results. The procedure will be repeated on the same eye twice consecutively. If the measurements are within 2mmHg or less of each other, the mean of the 2 reading will be reported as the IOP at that time point. If the 2 reading are more than 2mmHg apart from each other, a third (consecutive) reading will be taken and the median (middle) IOP will be reported as the IOP at that time point. Preferable, the same operator will measure IOP and the same tonometer will be used at each visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary endpoint analysis was conducted on the modified intent-to-treat (mITT) population, which consisted of all enrolled subjects randomized to masked study medication and who attended Visits 1,2,and 3 (minimally).'}, {'type': 'SECONDARY', 'title': 'Ocular Symptom and Tolerability Questionaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combigan BID', 'description': 'Combigan 0.2%/0.5% one drop BID\n\nCombigan BID'}, {'id': 'OG001', 'title': 'Simbrinza TID', 'description': 'Simbrinza 1/0.2% one drop TID\n\nSimbrinza TID'}], 'classes': [{'title': 'Baseline - Burning/Stinging Upon Instillation', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - non-instillation Burning/stinging', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Dry/Gritty Eye', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Foreign Body Sensation', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Eye Redness', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Blurred Vision', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Dry Mouth', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Bad Taste/change of taste', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Headache', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Baseline - Fatigue Malaise', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Burning/Stinging Upon Instillation', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Non-Instillation Burning/Stinging', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Dry/Gritty Eye', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Foreign Body Sensation', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Eye Redness', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Blurred Vision', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Dry Mouth', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Bad Taste/Change of Taste', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Headache', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2- Fatique Malaise', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Burning/Stinging Upon Instillation', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Non-Instillation Burning/Stinging', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Dry/Gritty Eye', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Foreign Body Sensation', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Eye Redness', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Blurred Vision', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Dry Mouth', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Bad Taste/Change of Taste', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Headache', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3- Fatigue Malaise', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Burning/Stinging Upon Instillation', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Non-Instillation Burning/Stinging', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Dry/Gritty Eye', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Foreign Body Sensation', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Eye Redness', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.73', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Blurred Vision', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Dry Mouth', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Bad Taste/Change of Taste', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Headache', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.33', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4- Fatigue Malaise', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90)', 'description': 'The secondary endpoint of this study was to determine the tolerability of each treatment group by utilizing ocular symptom questionnaires administered at each study visit. These questionnaires assessed Oral effects (bad taste, dry mouth) and Ocular comfort effects (itching, burning, stinging, burning on instillation, blurred vision). The scale proved was none=0, mild=1, moderate=2, severe=3.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Secondary endpoint analysis was conducted on the modified intent-to-treat (mITT) population, which consisted of all enrolled subjects randomized to masked study medication and who attended Visits 1,2,and 3 (minimally).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combigan Two Times Daily (BID)', 'description': 'Combigan 0.2%/0.5% one drop Two Times Daily (BID)\n\nCombigan Two Times Daily (BID)'}, {'id': 'FG001', 'title': 'Simbrinza Three Times Daily (TID)', 'description': 'Simbrinza 1/0.2% one drop Three Times Daily (TID)\n\nSimbrinza Three Times Daily (TID)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Randomized to incorrect Study Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Combigan Twice Daily (BID)', 'description': 'Combigan 0.2%/0.5% one drop Twice Daily (BID)\n\nCombigan Twice Daily (BID)'}, {'id': 'BG001', 'title': 'Simbrinza Three Times Daily (TID)', 'description': 'Simbrinza 1/0.2% one drop Three Times Daily (TID)\n\nSimbrinza Three Times Daily (TID)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'spread': '11.43', 'groupId': 'BG000'}, {'value': '67.7', 'spread': '8.43', 'groupId': 'BG001'}, {'value': '67.8', 'spread': '9.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was conducted on the Safety Population (N=43) for Subject Demographics.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-11', 'size': 753532, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-29T12:09', 'hasProtocol': True}, {'date': '2018-05-10', 'size': 103230, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-06T16:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2014-06-12', 'resultsFirstSubmitDate': '2018-03-29', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-23', 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure', 'timeFrame': 'Day 0 (08:00, 10:00 16:00), Day 30 (08:00, 10:00, 16:00), Day 90 (08:00, 10:00,16:00)', 'description': 'The Intraocular Pressure will be assessed on study subjects. IOP (Intraocular Pressure) will be measured using a Goldmann applanation tonometer. Both eyes will be tested, with the right eye preceding the left eye. The operator will initially set the dial at 10 mmHg, then look through the slit lamp and adjust the dial to take the reading, and then record the results. The procedure will be repeated on the same eye twice consecutively. If the measurements are within 2mmHg or less of each other, the mean of the 2 reading will be reported as the IOP at that time point. If the 2 reading are more than 2mmHg apart from each other, a third (consecutive) reading will be taken and the median (middle) IOP will be reported as the IOP at that time point. Preferable, the same operator will measure IOP and the same tonometer will be used at each visit.'}], 'secondaryOutcomes': [{'measure': 'Ocular Symptom and Tolerability Questionaire', 'timeFrame': 'Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90)', 'description': 'The secondary endpoint of this study was to determine the tolerability of each treatment group by utilizing ocular symptom questionnaires administered at each study visit. These questionnaires assessed Oral effects (bad taste, dry mouth) and Ocular comfort effects (itching, burning, stinging, burning on instillation, blurred vision). The scale proved was none=0, mild=1, moderate=2, severe=3.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open-Angle Glaucoma', 'Ocular Hypertension'], 'conditions': ['Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'To compare Combigan Two Times Daily (BID) vs Simbrinza Three Times Daily (TID) in subjects currently being treated with Latanoprost for Open-Angle Glaucoma or Ocular Hypertension. Both of these drugs are currently FDA approved as combination therapy for patients with Open-Angle Glaucoma or Ocular Hypertension. The purpose of this clinical trial would be to assess which treatment, if either, is superior in lowering intraocular pressure (IOP). A secondary objective is to assess the tolerability of each drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Open-angle glaucoma or ocular Hypertension\n* Currently treated with Latanoprost for min of 6 weeks\n* Male or Female 18 yrs and older\n* Best Corrected Visual Acuity 20/100 or better in both eyes\n* Pachymetry \\>470 and \\< 640\n* Women of childbearing potential must have a negative urine pregnancy test at the screening/baseline visit\n* Patient willing and capable of providing informed consent\n\nExclusion Criteria:\n\n* C/D \\> 0.8\n* Visual field loss, which in the opinion of the investigator is functionally significant\n* Current use of ocular steroids\n* Concurrent significant active ocular disease History (within 3 months prior to Screening) of ocular laser, intraocular, filtering or refractive surgery or planned ocular surgery of any kind during study participation\n* Change within prior 30 days or anticipated change in any systemic medication that is known to affect IOP\n* Uncontrolled systemic disease\n* Significant ocular hyperemia at baseline\n* Prior glaucoma procedure within 3 months\n* Females who are pregnant, nursing, or planning a pregnancy or who are of childbearing potential and not using a reliable method of contraception\n* Known allergy or sensitivity to any study medication\n* Asthma or any other known medical condition that the investigator feels would put patient at increased risk from any of the study medications\n* Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to Screening'}, 'identificationModule': {'nctId': 'NCT02167035', 'briefTitle': 'Comparison of Combigan Two Times Daily (BID) Versus Simbrinza Three Times Daily (TID)', 'organization': {'class': 'OTHER', 'fullName': 'Cornerstone Health Care, PA'}, 'officialTitle': 'Pilot Study Comparison of Combigan Two Times Daily (BID) vs Simbrinza Three Times Daily (TID) in Subjects Currently Treated With Latanoprost For Open-Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'TEP001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Combigan Two Times Daily (BID)', 'description': 'Combigan 0.2%/0.5% one drop Two Times Daily (BID)', 'interventionNames': ['Drug: Combigan Two Times Daily (BID)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Simbrinza Three Times Daily (TID)', 'description': 'Simbrinza 1/0.2% one drop Three Times Daily (TID)', 'interventionNames': ['Drug: Simbrinza Three Times Daily (TID)']}], 'interventions': [{'name': 'Combigan Two Times Daily (BID)', 'type': 'DRUG', 'armGroupLabels': ['Combigan Two Times Daily (BID)']}, {'name': 'Simbrinza Three Times Daily (TID)', 'type': 'DRUG', 'armGroupLabels': ['Simbrinza Three Times Daily (TID)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cornerstone Health Care', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}], 'overallOfficials': [{'name': 'Michael E Tepedino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cornerstone Health Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cornerstone Health Care, PA', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Research', 'investigatorFullName': 'Michael Tepedino MD', 'investigatorAffiliation': 'Cornerstone Health Care, PA'}}}}