Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT01300767
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2011-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Four Week Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-241-7629', 'title': 'Director of Clinical Trials', 'organization': 'Alcon Research'}, '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 events were collected for the duration of the trial: 09 FEB 2011 to 07 APR 2011.', 'description': 'This reporting group includes all enrolled and dispensed participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.', 'otherNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.', 'otherNumAtRisk': 74, 'otherNumAffected': 0, 'seriousNumAtRisk': 74, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Comfort on Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded 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 conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.'}, {'type': 'PRIMARY', 'title': 'Comfort During the Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Comfort at End of Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Daytime Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Low Light Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Handling on Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Handling at Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Delivers a Healthy, Natural Feeling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lens Awareness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Purchase Intent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.'}, {'id': 'OG001', 'title': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}, {'value': '35.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, "How likely would you be to purchase these lenses?" Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses.', 'unitOfMeasure': 'Percent likely to purchase', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lotrafilcon B /Balafilcon A', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Discomfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Biomicroscopy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Unacceptable fit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from 5 US study centers.', 'preAssignmentDetails': '• One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is included in the Actual Enrollment calculation, but not in the Participant Flow or Baseline Characteristics calculations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lotrafilcon B /Balafilcon A', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2011-02-18', 'resultsFirstSubmitDate': '2012-04-11', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-11', 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort on Insertion', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Comfort During the Day', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Comfort at End of Day', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Overall Comfort', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Daytime Vision', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Low Light Vision', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Handling on Insertion', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.'}, {'measure': 'Handling at Removal', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.'}, {'measure': 'Delivers a Healthy, Natural Feeling', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Lens Awareness', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.'}, {'measure': 'Overall Satisfaction', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.'}, {'measure': 'Purchase Intent', 'timeFrame': '4 weeks', 'description': 'As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, "How likely would you be to purchase these lenses?" Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to 4 weeks in a daily wear modality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater.\n* Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.\n* Willing and able to wear spherical contact lenses within the available range of powers.\n* Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Eye injury or surgery within twelve weeks prior to enrollment.\n* Currently enrolled in any clinical trial.\n* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.\n* Astigmatism of 1.00D or more.\n* Currently wearing contact lenses in a daily disposable modality.\n* Currently wearing AIR OPTIX AQUA or PureVision 2 contact lenses\n* Currently sleeping overnight in contact lenses on an occasional or extended wear basis.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01300767', 'briefTitle': 'Four Week Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': '4 Week Performance Comparison Between 2 Commercially Available Silicone Hydrogel Lenses', 'orgStudyIdInfo': {'id': 'P-336-C-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lotrafilcon B', 'description': 'Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.', 'interventionNames': ['Device: Lotrafilcon B contact lens (AIR OPTIX® AQUA)', 'Device: Contact lens solution (Clear Care®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Balafilcon A', 'description': 'Balafilcon A commercially marketed contact lens randomly assigned to one eye, with lotrafilcon B commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks in a daily wear (DW) modality.', 'interventionNames': ['Device: Balafilcon A contact lens (PureVision® 2)', 'Device: Contact lens solution (Clear Care®)']}], 'interventions': [{'name': 'Lotrafilcon B contact lens (AIR OPTIX® AQUA)', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX® AQUA'], 'description': 'Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.', 'armGroupLabels': ['Lotrafilcon B']}, {'name': 'Balafilcon A contact lens (PureVision® 2)', 'type': 'DEVICE', 'otherNames': ['PureVision® 2'], 'description': 'Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.', 'armGroupLabels': ['Balafilcon A']}, {'name': 'Contact lens solution (Clear Care®)', 'type': 'DEVICE', 'otherNames': ['Clear Care®'], 'description': 'Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.', 'armGroupLabels': ['Balafilcon A', 'Lotrafilcon B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CIBA VISION', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}