Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:01 AM
Study NCT ID:
NCT00798694
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2008-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077338', 'term': 'Latanoprost'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D000069557', 'term': 'Travoprost'}], 'ancestors': [{'id': 'D011461', 'term': 'Prostaglandins F, 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'}, {'id': 'D003008', 'term': 'Cloprostenol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ljaykatz@gmail.com', 'phone': '215-928-3197', 'title': 'Principal Investigator', 'organization': 'Wills Eye Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size. Short term study may not reflect long term ocular surface. Patients selected were free of baseline Ocular Surface Disease (OSD). Sample population with pre-existing OSD may have different sensitivity.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline, 1 month, 2 months', 'eventGroups': [{'id': 'EG000', 'title': 'New to Meds', 'description': 'Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.\n\nXalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime\n\nTravatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Currently on Xalatan', 'description': 'Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.\n\nXalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime\n\nTravatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Tear Break up Time (TBUT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'New to Meds', 'description': 'Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.\n\nXalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime\n\nTravatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime\n\nA geometric mean ratio of 1 indicates equivalence of the two geometric means.'}, {'id': 'OG001', 'title': 'Currently on Xalatan', 'description': 'Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.\n\nXalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime\n\nTravatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime'}], 'classes': [{'title': '1 month', 'categories': [{'measurements': [{'value': '-0.86', 'spread': '6.09', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '4.70', 'groupId': 'OG001'}]}]}, {'title': '2 months', 'categories': [{'measurements': [{'value': '-2.00', 'spread': '5.42', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '4.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null Hypothesis: There is no significant difference in tear break-up time between the group "New to Meds" and the group "Currently on Xalatan" at two months.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': 'Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both eyes combined change from baseline.'}, {'type': 'SECONDARY', 'title': 'Tear Production', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (New to Meds)', 'description': 'Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.\n\nXalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime\n\nTravatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime'}, {'id': 'OG001', 'title': 'Group 2 (Currently on Xalatan)', 'description': 'Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.\n\nXalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime\n\nTravatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.4', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': '1 month', 'categories': [{'measurements': [{'value': '21.1', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '9.0', 'groupId': 'OG001'}]}]}, {'title': '2 months', 'categories': [{'measurements': [{'value': '23.0', 'spread': '9.35', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': 'Tear production, measured by Schirmer test in millimeters', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Conjunctival Hyperemia Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Xalatan', 'description': '28 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)'}, {'id': 'OG001', 'title': 'Group 1 Travatan Z', 'description': '28 patients - Eye using Travatan Z (travoprost with SofZia)'}, {'id': 'OG002', 'title': 'Group 2 Xalatan', 'description': '27 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)'}, {'id': 'OG003', 'title': 'Group 2 Travatan Z', 'description': '27 patients - Eye using Travatan Z (travoprost with SofZia)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '2.6', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '3.2', 'groupId': 'OG003'}]}]}, {'title': '1 month', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '3.2', 'groupId': 'OG003'}]}]}, {'title': '2 months', 'categories': [{'measurements': [{'value': '4.0', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '3.3', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '3.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': 'Conjunctival hyperemia is the amount of redness on the white part of the eye. A total score was obtained by the sum of assessments in 6 areas of each eye are which are scored from 0 to 3 (0 = no redness; 3 = severe redness), then summed per eye for a total score range of 0-18 (0 = no redness; 18 = severe redness).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One eye per participant in each Arm'}, {'type': 'SECONDARY', 'title': 'Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Xalatan', 'description': '28 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)'}, {'id': 'OG001', 'title': 'Group 1 Travatan Z', 'description': '28 patients - Eye using Travatan Z (travoprost with SofZia)'}, {'id': 'OG002', 'title': 'Group 2 Xalatan', 'description': '27 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)'}, {'id': 'OG003', 'title': 'Group 2 Travatan Z', 'description': '27 patients - Eye using Travatan Z (travoprost with SofZia)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.9', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '20.1', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '14.8', 'spread': '2.7', 'groupId': 'OG002'}, {'value': '15.0', 'spread': '3.3', 'groupId': 'OG003'}]}]}, {'title': '1 month', 'categories': [{'measurements': [{'value': '15.6', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '15.1', 'spread': '2.8', 'groupId': 'OG002'}, {'value': '14.5', 'spread': '2.8', 'groupId': 'OG003'}]}]}, {'title': '2 months', 'categories': [{'measurements': [{'value': '14.6', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '14.6', 'spread': '3.3', 'groupId': 'OG002'}, {'value': '14.3', 'spread': '3.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': 'Intraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ocular Surface Disease Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Xalatan', 'description': '28 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)'}, {'id': 'OG001', 'title': 'Group 1 Travatan Z', 'description': '28 patients - Eye using Travatan Z (travoprost with SofZia)'}, {'id': 'OG002', 'title': 'Group 2 Xalatan', 'description': '27 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)'}, {'id': 'OG003', 'title': 'Group 2 Travatan Z', 'description': '27 patients - Eye using Travatan Z (travoprost with SofZia)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.8', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '11.4', 'groupId': 'OG002'}, {'value': '14.2', 'spread': '17.7', 'groupId': 'OG003'}]}]}, {'title': '1 month', 'categories': [{'measurements': [{'value': '10.8', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '6.9', 'groupId': 'OG002'}, {'value': '8.1', 'spread': '7.7', 'groupId': 'OG003'}]}]}, {'title': '2 months', 'categories': [{'measurements': [{'value': '11.1', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '8.7', 'groupId': 'OG002'}, {'value': '11.2', 'spread': '18.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': "Ocular Surface Disease Index Scores (OSDI) were obtained from a 12-item validated OSDI questionnaire completed by each participant. This is an assessment related to eye comfort. Each question's score ranges from 0 = no disability to 4 = greatest disability. The total score is multiplied by 25 then divided by the number of questions answered then matched to a grid ranging from 0 to 100 with 0 having symptoms reported none of the time versus 100 having disability symptoms reported all of the time.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Staining Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Xalatan', 'description': '28 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)'}, {'id': 'OG001', 'title': 'Group 1 Travatan Z', 'description': '28 patients - Eye using Travatan Z (travoprost with SofZia)'}, {'id': 'OG002', 'title': 'Group 2 Xalatan', 'description': '27 patients - Eye using Xalatan (latanoprost with benzalkonium chloride)'}, {'id': 'OG003', 'title': 'Group 2 Travatan Z', 'description': '27 patients - Eye using Travatan Z (travoprost with SofZia)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '1.8', 'groupId': 'OG003'}]}]}, {'title': '1 month', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': '2 months', 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '0.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': 'Corneal staining is an indication of the amount of dryness of the cornea (front clear part of the eye). A total score was obtained by the sum of assessments in five areas of each eye which are scored from 0 to 3 (0 = no dryness; 3 = severe dryness), then summed per eye for a total score range of 0-15 (0 = no dryness; 15 = severe dryness).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One eye from each patient per arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 (New to Meds)', 'description': 'Naive to glaucoma therapy medical or surgical. These patients have never used eye drops to lower eye pressure. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.\n\nXalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime\n\nTravatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime'}, {'id': 'FG001', 'title': 'Group 2 (Currently on Xalatan)', 'description': 'Patients currently on Xalatan at least one month. These patients have been using Xalatan at least one month to lower their eye pressure. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.\n\nXalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime\n\nTravatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 (New to Meds)', 'description': 'Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.\n\nXalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime\n\nTravatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime'}, {'id': 'BG001', 'title': 'Group 2 (Currently on Xalatan)', 'description': 'Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.\n\nXalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime\n\nTravatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.6', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '61.2', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': "58 patients were enrolled. 2 patients did not return for follow-up and 1 patient's intraocular pressure was not controlled adequately on one eye drop. That patient was discontinued when a second eye drop was added to lower their eye pressure."}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Doctors assessing patients were masked to treatment. Patients used open label Xalantan in the right eye and Travatan Z in the left eye.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2008-11-25', 'resultsFirstSubmitDate': '2016-01-07', 'studyFirstSubmitQcDate': '2008-11-25', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-11', 'studyFirstPostDateStruct': {'date': '2008-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Tear Break up Time (TBUT)', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': 'Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment.'}], 'secondaryOutcomes': [{'measure': 'Tear Production', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': 'Tear production, measured by Schirmer test in millimeters'}, {'measure': 'Conjunctival Hyperemia Score', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': 'Conjunctival hyperemia is the amount of redness on the white part of the eye. A total score was obtained by the sum of assessments in 6 areas of each eye are which are scored from 0 to 3 (0 = no redness; 3 = severe redness), then summed per eye for a total score range of 0-18 (0 = no redness; 18 = severe redness).'}, {'measure': 'Intraocular Pressure', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': 'Intraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged.'}, {'measure': 'Ocular Surface Disease Index Score', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': "Ocular Surface Disease Index Scores (OSDI) were obtained from a 12-item validated OSDI questionnaire completed by each participant. This is an assessment related to eye comfort. Each question's score ranges from 0 = no disability to 4 = greatest disability. The total score is multiplied by 25 then divided by the number of questions answered then matched to a grid ranging from 0 to 100 with 0 having symptoms reported none of the time versus 100 having disability symptoms reported all of the time."}, {'measure': 'Corneal Staining Score', 'timeFrame': 'Baseline, 1 month, 2 months', 'description': 'Corneal staining is an indication of the amount of dryness of the cornea (front clear part of the eye). A total score was obtained by the sum of assessments in five areas of each eye which are scored from 0 to 3 (0 = no dryness; 3 = severe dryness), then summed per eye for a total score range of 0-15 (0 = no dryness; 15 = severe dryness).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glaucoma', 'impression cytology', 'ocular surface changes', 'prostaglandins'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Gupta SR, Ichhpujani P, Wizov SS, Wittpenn JR, Moster MR, Pro MJ, Rapuano CJ, Cruz-Colon C, Myers JS, Katz LJ. Effects of Latanoprost Versus Travoprost with Sofzia on Ocular Surface. ARVO E-abstract 168/A391 2010'}, {'pmid': '28617732', 'type': 'RESULT', 'citation': 'Rahmatnejad K, Rapuano CJ, Ichhpujani P, Wizov SS, Moster MR, Hark LA, Katz LJ. The Effects of Latanoprost With Benzalkonium Chloride Versus Travoprost With SofZia on the Ocular Surface. Eye Contact Lens. 2018 Nov;44 Suppl 2:S93-S98. doi: 10.1097/ICL.0000000000000405.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether one glaucoma eye drop is less likely to cause changes to the surface of the eye (conjunctiva) than another. The two different prostaglandins are Xalatan and Travatan Z.', 'detailedDescription': 'Two groups will be entered into this study: group 1 will be naive to treatment and group 2 will be using Xalatan for at least one month before enrollment. Both groups will be using one drop at bedtime of Xalatan in the right eye and one drop at bedtime of Travatan Z in the left eye. Both of these drops are presently on the market and approved by the FDA for treatment of lowering eye pressure. Because this study will be masked, the examining clinician will not know what study drop each patient has been using.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 or older\n* Able to understand protocol and agree to 3 visits\n* Any type of glaucoma\n* Selective laser trabeculoplasty, Argon laser trabeculoplasty, peripheral iridotomy accepted\n* Naïve: No prior glaucoma treatment (medical or surgical)\n* If patient non-compliant, must be off meds 3 months\n* Xalatan: At least one month use\n\nExclusion Criteria:\n\n* Both Groups: Any history of ocular surface disease\n* Dry eye syndrome or prior Restasis use\n* Prior ocular surgery other than cataract extractions\n* Uveitis or other inflammatory disease of the eye or adnexa\n* Systemic medications that might influence ocular inflammation\n* Any active inflammation or infection\n* Pregnancy or intention to become pregnant\n* Naïve: Prior use of topical glaucoma medication unless off for 3 months.\n* Use of preserved artificial tear preparations in last 30 days and more than one year history of chronic use\n* Xalatan: Prior use of Travatan or Travatan Z'}, 'identificationModule': {'nctId': 'NCT00798694', 'briefTitle': 'How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'Ocular Surface Changes With Topical Prostaglandin Analog Therapy', 'orgStudyIdInfo': {'id': '08-875'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'New to Meds', 'description': 'Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.', 'interventionNames': ['Drug: Xalatan', 'Drug: Travatan Z']}, {'type': 'OTHER', 'label': 'Currently on Xalatan', 'description': 'Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.', 'interventionNames': ['Drug: Xalatan', 'Drug: Travatan Z']}], 'interventions': [{'name': 'Xalatan', 'type': 'DRUG', 'otherNames': ['prostaglandin analog'], 'description': 'one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime', 'armGroupLabels': ['Currently on Xalatan', 'New to Meds']}, {'name': 'Travatan Z', 'type': 'DRUG', 'otherNames': ['prostaglandin analog'], 'description': 'one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime', 'armGroupLabels': ['Currently on Xalatan', 'New to Meds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Glaucoma Service', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Leslie J Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Glaucoma Service'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'A manuscript has been published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wills Eye', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'L. Jay Katz MD', 'investigatorAffiliation': 'Wills Eye'}}}}