Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-30 @ 4:34 PM
Study NCT ID:
NCT01863368
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
2013-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Global Brand Med Affairs Lead, Pharma, GCRA', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected for the duration of the study (Sep 2013 - Jun 2014). AEs are reported as pre-treatment and treatment-emergent. One subject was randomized to Optive, but was never exposed to product.', 'description': 'An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the product. AEs were obtained as solicited and spontaneous comments from the study subjects, and as observations by the Investigator, as outlined in the protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-treatment', 'description': 'All subjects who consented to participate in the study prior to exposure to investigational product', 'otherNumAtRisk': 105, 'otherNumAffected': 1, 'seriousNumAtRisk': 105, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Systane Ultra', 'description': 'All subjects who were exposed to Systane Ultra or run-in therapy', 'otherNumAtRisk': 46, 'otherNumAffected': 2, 'seriousNumAtRisk': 46, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Optive', 'description': 'All subjects who were exposed to Optive or run-in therapy', 'otherNumAtRisk': 47, 'otherNumAffected': 3, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Spinal column injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Ultra', 'description': 'Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}, {'id': 'OG001', 'title': 'Optive', 'description': 'Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 35', 'description': 'The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group includes all randomized subjects with data at visit.'}, {'type': 'SECONDARY', 'title': 'Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Ultra', 'description': 'Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}, {'id': 'OG001', 'title': 'Optive', 'description': 'Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}], 'classes': [{'categories': [{'measurements': [{'value': '31.0', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '35.4', 'spread': '17.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 35', 'description': 'The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group includes all subjects with data at visit.'}, {'type': 'SECONDARY', 'title': 'Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Ultra', 'description': 'Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}, {'id': 'OG001', 'title': 'Optive', 'description': 'Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}], 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '27.3', 'groupId': 'OG000'}, {'value': '55.7', 'spread': '29.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 35', 'description': 'The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group includes all subjects with data at visit.'}, {'type': 'SECONDARY', 'title': 'Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane Ultra', 'description': 'Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}, {'id': 'OG001', 'title': 'Optive', 'description': 'Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}], 'classes': [{'categories': [{'measurements': [{'value': '69.5', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '23.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 35', 'description': 'The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis group includes all subjects with data at visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Systane Ultra', 'description': 'Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}, {'id': 'FG001', 'title': 'Optive', 'description': 'Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}], 'periods': [{'title': 'Phase I, Day 0 to Day 35', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by subject prior to treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Phase II, Day 35 to Day 90', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 13 study centers located in France and 3 study centers located in Germany.', 'preAssignmentDetails': 'Of the 105 enrolled, 11 subjects were exited prior to randomization: 9 screen failures, 1 adverse event, and 1 lost to follow-up. This reporting group includes all randomized subjects (94).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Systane Ultra', 'description': 'Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}, {'id': 'BG001', 'title': 'Optive', 'description': 'Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '14.3', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean Total Ocular Surface Staining (TOSS) Score', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '5.5', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '5.5', 'spread': '1.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis. Here, the analysis group includes all randomized subjects with data at visit (46,47 respectively, for a total of 93).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'This analysis group includes all randomized subjects.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-09', 'studyFirstSubmitDate': '2013-05-23', 'resultsFirstSubmitDate': '2015-06-17', 'studyFirstSubmitQcDate': '2013-05-24', 'lastUpdatePostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-17', 'studyFirstPostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)', 'timeFrame': 'Baseline, Day 35', 'description': 'The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.'}], 'secondaryOutcomes': [{'measure': 'Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)', 'timeFrame': 'Day 35', 'description': 'The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.'}, {'measure': 'Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)', 'timeFrame': 'Day 35', 'description': 'The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.'}, {'measure': 'Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)', 'timeFrame': 'Day 35', 'description': 'The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dry eye syndrome', 'Systane Ultra', 'Optive', 'Ocular Surface Staining', 'OSDI', 'Eye drops'], 'conditions': ['Dry Eye Syndrome']}, 'referencesModule': {'references': [{'pmid': '27422973', 'type': 'DERIVED', 'citation': 'Labetoulle M, Messmer EM, Pisella PJ, Ogundele A, Baudouin C. Safety and efficacy of a hydroxypropyl guar/polyethylene glycol/propylene glycol-based lubricant eye-drop in patients with dry eye. Br J Ophthalmol. 2017 Apr;101(4):487-492. doi: 10.1136/bjophthalmol-2016-308608. Epub 2016 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.', 'detailedDescription': 'Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to attend all study visits.\n* Diagnosis of dry eye, as specified in protocol.\n* Uses artificial tears, as specified in protocol.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Poor visual acuity, as specified in protocol.\n* Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.\n* Any hypersensitivity or allergy to the investigational products or ingredients.\n* Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.\n* Contact lens use within 2 weeks of Screening Visit.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01863368', 'briefTitle': 'Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining', 'orgStudyIdInfo': {'id': 'M-12-040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Systane Ultra', 'description': 'Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).', 'interventionNames': ['Other: Preservative-free saline solution eyedrops', 'Other: Systane® ULTRA lubricant eyedrops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Optive', 'description': 'OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).', 'interventionNames': ['Other: Preservative-free saline solution eyedrops', 'Other: OPTIVE® lubricating eyedrops']}], 'interventions': [{'name': 'Preservative-free saline solution eyedrops', 'type': 'OTHER', 'description': '1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.', 'armGroupLabels': ['Optive', 'Systane Ultra']}, {'name': 'Systane® ULTRA lubricant eyedrops', 'type': 'OTHER', 'armGroupLabels': ['Systane Ultra']}, {'name': 'OPTIVE® lubricating eyedrops', 'type': 'OTHER', 'armGroupLabels': ['Optive']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Steve Burmaster', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}