Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-04-14 @ 3:24 PM
Study NCT ID:
NCT01635933
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2012-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS
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': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Sharon Holden Thomas, O.D., Sr. Principal Clinical Scientist', '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 (AE) were collected for the duration of the study (3 months). AEs were obtained as solicited comments from subjects and as observations by the study Investigator as outlined in the study protocol.', 'description': 'The analysis population includes all participants exposed to the study product. An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings), whether or not related to the investigational medical device.', 'eventGroups': [{'id': 'EG000', 'title': 'AIR OPTIX® COLORS', 'description': 'Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.', 'otherNumAtRisk': 178, 'otherNumAffected': 0, 'seriousNumAtRisk': 178, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'FRESHLOOK® COLORBLENDS', 'description': 'Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.', 'otherNumAtRisk': 185, 'otherNumAffected': 0, 'seriousNumAtRisk': 185, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Corneal abrasion', 'notes': 'Not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Injury', 'notes': 'Injuries due to a car accident. Not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cholecystitis infective', 'notes': 'Not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 178, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 185, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Rating of Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIR OPTIX® COLORS', 'description': 'Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.'}, {'id': 'OG001', 'title': 'FRESHLOOK® COLORBLENDS', 'description': 'Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.'}], 'classes': [{'title': 'Day 14 (n=175,181)', 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (n=176,176)', 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 28', 'description': 'Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group.'}, {'type': 'SECONDARY', 'title': 'Subjective Rating of Overall Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIR OPTIX® COLORS', 'description': 'Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.'}, {'id': 'OG001', 'title': 'FRESHLOOK® COLORBLENDS', 'description': 'Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.'}], 'classes': [{'title': 'Day 14 (n=175,181)', 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28 (n=176,177)', 'categories': [{'measurements': [{'value': '8.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 28', 'description': 'Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AIR OPTIX® COLORS', 'description': 'Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.'}, {'id': 'OG001', 'title': 'FRESHLOOK® COLORBLENDS', 'description': 'Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000'}, {'value': '45.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': "Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes all enrolled and dispensed participants who had at least 1 study visit after being dispensed the study lenses. No imputation was used for missing values.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AIR OPTIX® COLORS', 'description': 'Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.'}, {'id': 'FG001', 'title': 'FRESHLOOK® COLORBLENDS', 'description': 'Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '177'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Subject decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No longer had transportation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited from 24 study centers located in the United States.', 'preAssignmentDetails': 'Of the 370 participants enrolled and randomized, 4 did not meet inclusion/exclusion criteria, 2 were lost to follow-up, and 1 declined participation. This reporting group includes all participants exposed to the study product (363).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '178', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '363', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AIR OPTIX® COLORS', 'description': 'Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.'}, {'id': 'BG001', 'title': 'FRESHLOOK® COLORBLENDS', 'description': 'Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '16-17 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': '18-64 years', 'categories': [{'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '330', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The analysis population includes all participants exposed to the study product (363).'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-25', 'studyFirstSubmitDate': '2012-07-05', 'resultsFirstSubmitDate': '2014-02-18', 'studyFirstSubmitQcDate': '2012-07-09', 'lastUpdatePostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-18', 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Rating of Overall Comfort', 'timeFrame': 'Up to Day 28', 'description': 'Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.'}], 'secondaryOutcomes': [{'measure': 'Subjective Rating of Overall Vision', 'timeFrame': 'Up to Day 28', 'description': 'Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.'}, {'measure': 'Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)', 'timeFrame': 'Day 28', 'description': "Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contact lenses', 'color contact lenses', 'myopia'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the overall comfort of AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS in habitual wearers of the FRESHLOOK® COLORBLENDS .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able and willing to sign the Informed Consent document. If under legal age of consent, legally authorized representative must sign also Informed Consent document.\n* Able to achieve visual acuity of at least 20/30 (Snellen) in each eye at distance with contact lenses and best corrected visual acuity (BCVA) ≥ 20/25 in each eye.\n* Manifest cylinder less than or equal to 0.75 diopters (within the previous year) in each eye.\n* Successful wear of FRESHLOOK® COLORBLENDS spherical soft contact lenses in both eyes (in the protocol-specified colors) during the past three months for a minimum of 5 days per week and 8 hours per day.\n* History of at least 5 days of successful use with both lenses (minimum of 8 hours/day) of one of the protocol-specified lens care solutions/multi-purpose solutions (MPS).\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of this study.\n* Wears habitual lenses in an extended wear modality (sleeping in lenses overnight / not removing lenses on a daily basis).\n* Monovision, monocular (only one eye with functional vision) or fit with only one lens.\n* History of intolerance or hypersensitivity to any component of the test articles.\n* Use of any over-the-counter or prescribed topical ocular medications within the previous 7 days (excluding rewetting drops).\n* Moderate or severe corneal edema, corneal vascularization, corneal staining, injection, tarsal abnormalities, "other" complications; and any corneal infiltrates.\n* Current or history of ocular infection, severe inflammation, or disease within previous 6 months.\n* Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions.\n* Participation in any investigational clinical study within previous 30 days.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01635933', 'briefTitle': 'A Comparison of AIR OPTIX® COLORS Versus FRESHLOOK® COLORBLENDS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'A Comparison of a Colored Silicone Hydrogel Lens Versus a Colored HEMA Lens', 'orgStudyIdInfo': {'id': 'C-12-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AIR OPTIX® COLORS', 'description': 'Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.', 'interventionNames': ['Device: Lotrafilcon B contact lens with color']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FRESHLOOK® COLORBLENDS', 'description': 'Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.', 'interventionNames': ['Device: Phemfilcon A contact lens with color']}], 'interventions': [{'name': 'Lotrafilcon B contact lens with color', 'type': 'DEVICE', 'otherNames': ['AIR OPTIX® COLORS'], 'description': 'Silicone hydrogel contact lens with color.', 'armGroupLabels': ['AIR OPTIX® COLORS']}, {'name': 'Phemfilcon A contact lens with color', 'type': 'DEVICE', 'otherNames': ['FRESHLOOK® COLORBLENDS'], 'description': 'Hydrogel contact lens with color.', 'armGroupLabels': ['FRESHLOOK® COLORBLENDS']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sharon Holden Thomas, O.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}