Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-04-15 @ 6:49 PM
Study NCT ID:
NCT02380261
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Study of Systane® Lid Wipes in Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Dir Clinical Operations - LACAR, GCRA', 'organization': 'Alcon, a Novartis company'}, '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 participation in the study (up to 21 days). This analysis group includes all enrolled participants. Ocular AEs are presented for both study eye and non-study eye combined.', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a product and that does not necessarily have a causal relationship with this treatment. All AEs were obtained as solicited and spontaneous comments from the study participants and through regular investigator assessment throughout the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Systane', 'description': 'Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days', 'otherNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Contact-dermatitis Adverse Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane', 'description': 'Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 21', 'description': 'Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all enrolled participants.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Ocular Clinical Signs and Discomfort Sensations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Systane', 'description': 'Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 21', 'description': 'Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all enrolled participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Systane', 'description': 'Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from 1 study center located in Brazil.', 'preAssignmentDetails': 'Thirty-five participants were enrolled in this study. This reporting group includes all enrolled participants (35).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Systane', 'description': 'Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 18-70', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2015-02-27', 'resultsFirstSubmitDate': '2016-08-09', 'studyFirstSubmitQcDate': '2015-03-04', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-29', 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Contact-dermatitis Adverse Reaction', 'timeFrame': 'Day 21', 'description': 'Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.'}, {'measure': 'Number of Participants With Ocular Clinical Signs and Discomfort Sensations', 'timeFrame': 'Day 21', 'description': 'Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ocular Tolerance', 'Skin Tolerance']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must sign informed consent.\n* Agree to adhere to the procedures and requirements of the study.\n* Wears makeup daily.\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Ocular conditions as specified in protocol.\n* Medical conditions as specified in protocol.\n* Skin conditions as specified in protocol.\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02380261', 'briefTitle': 'A Clinical Study of Systane® Lid Wipes in Brazil', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Assessment Of The Skin And Ocular Tolerance Of The Product Systane® Lid Wipes (050343-01) And Assessment Of The Study Subject Acceptance, Under Normal Use Conditions', 'orgStudyIdInfo': {'id': 'EXR338-P001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Systane', 'description': 'Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days', 'interventionNames': ['Other: Systane® Lid Wipes']}], 'interventions': [{'name': 'Systane® Lid Wipes', 'type': 'OTHER', 'description': 'Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning', 'armGroupLabels': ['Systane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04636-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Novartis Biociencias SA', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'NOVARTIS BIOCIENCIAS S/A', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}