Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-01 @ 12:30 PM
Study NCT ID:
NCT03392532
Status:
COMPLETED
Last Update Posted:
2019-01-29
First Post:
2018-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Silicone Hydrogel Toric Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'CDMA Project Lead, CDMA Vision Care', 'organization': 'Alcon, A Novartis Division'}, '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': 'Dispense through study completion, approximately 2 hours', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the protocol. This analysis population includes all subjects/eyes exposed to any study lenses evaluated.', 'eventGroups': [{'id': 'EG000', 'title': 'AOHG Toric', 'description': 'All subjects exposed to lotrafilcon B toric contact lenses with HYDRAGLYDE® in Period 1 or Period 2, as randomized', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AO Toric', 'description': 'All subjects exposed to lotrafilcon B toric contact lenses in Period 1 or Period 2, as randomized', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AOHG Toric', 'description': 'Lotrafilcon B toric contact lenses with HYDRAGLYDE® worn in both eyes for approximately 30 minutes during either Period 1 or Period 2, as randomized'}, {'id': 'OG001', 'title': 'AO Toric', 'description': 'Lotrafilcon B toric contact lenses worn in both eyes for approximately 30 minutes in either Period 1 or Period 2, as randomized'}], 'classes': [{'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000'}, {'value': '95.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, 10 minutes after lens insertion, each product', 'description': 'Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.', 'unitOfMeasure': 'percentage of lenses', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AOHG Toric, Then AO Toric', 'description': 'Lotrafilcon B toric contact lenses with HYDRAGLYDE®, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.'}, {'id': 'FG001', 'title': 'AO Toric, Then AOHG Toric', 'description': 'Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE®, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.'}], 'periods': [{'title': 'Period 1, FIrst 30 Minutes of Wear', 'milestones': [{'type': 'STARTED', 'comment': 'As randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2, Second 30 Minutes of Wear', 'milestones': [{'type': 'STARTED', 'comment': 'As randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from one investigative site located in the US.', 'preAssignmentDetails': 'This reporting group includes all enrolled subjects (36).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'Lotrafilcon B toric contact lenses with HYDRAGLYDE® and lotrafilcon B toric contact lenses worn during Period 1 and Period 2 in a crossover assignment'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'spread': '13.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized subjects exposed to any study lenses evaluated in this study (Full Analysis Set).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-17', 'size': 4456346, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-04T08:17', 'hasProtocol': True}, {'date': '2017-12-11', 'size': 1682618, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-04T08:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2018-01-02', 'resultsFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-07', 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)', 'timeFrame': 'Day 1, 10 minutes after lens insertion, each product', 'description': 'Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Astigmatism', 'Axis orientation'], 'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to compare the performance of two different types of Alcon soft toric study contact lenses to obtain information on study lens orientation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Successful wear of soft contact lenses for vision correction in both eyes during the past 3 months for a minimum of 3 days per week and 8 hours per day\n* Astigmatism\n* Requires contact lenses\n* Best corrected visual acuity of 20/25 or better in each eye\n* Other protocol-specified inclusion criteria may apply\n\nExclusion Criteria:\n\n* Any eye condition that contraindicates contact lens wear, as determined by the Investigator\n* Any eye surgery that contraindicates contact lens wear, as determined by the Investigator\n* Other protocol-specified exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03392532', 'briefTitle': 'Comparison of Two Silicone Hydrogel Toric Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses', 'orgStudyIdInfo': {'id': 'CLC127-C001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'AOHG toric, then AO toric', 'description': 'Lotrafilcon B toric contact lenses with HYDRAGLYDE, followed by lotrafilcon B toric contact lenses, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.', 'interventionNames': ['Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE', 'Device: Lotrafilcon B toric contact lenses']}, {'type': 'OTHER', 'label': 'AO toric, then AOHG toric', 'description': 'Lotrafilcon B toric contact lenses, followed by lotrafilcon B toric contact lenses with HYDRAGLYDE, as randomized. Each product worn in both eyes for approximately 30 minutes, with a 30-45 minute washout between the removal of Pair 1 and insertion of Pair 2.', 'interventionNames': ['Device: Lotrafilcon B toric contact lenses with HYDRAGLYDE', 'Device: Lotrafilcon B toric contact lenses']}], 'interventions': [{'name': 'Lotrafilcon B toric contact lenses with HYDRAGLYDE', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX® plus HYDRAGLYDE® for Astigmatism contact lenses', 'AOHG for Astigmatism'], 'description': 'Silicone hydrogel soft contact lenses for astigmatism', 'armGroupLabels': ['AO toric, then AOHG toric', 'AOHG toric, then AO toric']}, {'name': 'Lotrafilcon B toric contact lenses', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX® for Astigmatism contact lenses', 'AO for Astigmatism'], 'description': 'Silicone hydrogel soft contact lenses for astigmatism', 'armGroupLabels': ['AO toric, then AOHG toric', 'AOHG toric, then AO toric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30097', 'city': 'Johns Creek', 'state': 'Georgia', 'country': 'United States', 'facility': 'Alcon Investigative Site', 'geoPoint': {'lat': 34.02893, 'lon': -84.19858}}], 'overallOfficials': [{'name': 'Alcon, A Novartis Division', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon, A Novartis Division'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}