Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 1:11 PM
Study NCT ID:
NCT00933166
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2009-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'priya.janakiraman@cibavision.com', 'phone': '1-800-241-7629', 'title': 'Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs', 'organization': 'CIBA VISION'}, 'certainAgreement': {'otherDetails': "For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for the duration of the trial: 4 months, 16 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Lotrafilcon A', 'description': 'Investigational contact lens worn in both eyes for three months', 'otherNumAtRisk': 169, 'otherNumAffected': 0, 'seriousNumAtRisk': 169, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort After Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon A', 'description': 'Investigational contact lens worn in both eyes for three months'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': "Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per protocol and excluded ten major protocol deviations as determined by masked review. Eighteen participants discontinued prior to the Month 3 visit. Nineteen participants responded N/A due to reasons such as continual wear.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lotrafilcon A', 'description': 'Investigational contact lens worn in both eyes for three months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Unavailable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lotrafilcon A', 'description': 'Investigational contact lens worn in both eyes for three months'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '12.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '115', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2009-07-02', 'resultsFirstSubmitDate': '2010-12-02', 'studyFirstSubmitQcDate': '2009-07-06', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-02', 'studyFirstPostDateStruct': {'date': '2009-07-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort After Insertion', 'timeFrame': '3 months', 'description': "Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.\n* Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.\n* Be able to wear the study lenses in the available powers.\n* Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.\n* Other protocol-defined inclusion/exclusion criteria may apply.\n\nExclusion Criteria:\n\n* Eye injury or surgery within twelve weeks of enrollment.\n* Pre-existing ocular irritation that would preclude contact lens fitting.\n* Currently enrolled in an ophthalmic clinical trial.\n* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.\n* History of corneal refractive surgery.\n* Other protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00933166', 'briefTitle': 'Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period', 'orgStudyIdInfo': {'id': 'P-335-C-014v2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lotrafilcon A', 'description': 'Investigational contact lens worn in both eyes for three months', 'interventionNames': ['Device: Lotrafilcon A contact lens']}], 'interventions': [{'name': 'Lotrafilcon A contact lens', 'type': 'DEVICE', 'description': 'Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months', 'armGroupLabels': ['Lotrafilcon A']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}