Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT01526902
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2012-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Proclear 1-D Multifocal Nondispensing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kollbaum@indiana.edu', 'phone': '812-856-0108', 'title': 'Pete Kollbaum, OD, PhD, FAAO, FBCLA, Principal Investigator', 'organization': 'Indiana University'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Omafilcon A / PC1DMF L2A (TEST)', 'description': 'Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lotrafilcon B / Air Optix MF (CONTROL)', 'description': 'Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Vision Assessments: High Contrast Distance Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PC1DMF', 'description': '(Test Lens) omafilcon A Proclear 1-D multifocal lens'}, {'id': 'OG001', 'title': 'Air Optix MF', 'description': '(Control Lens) lotrafilcon B Air Optix Aqua Multifocal'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.', 'unitOfMeasure': 'logMAR units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}, {'type': 'SECONDARY', 'title': 'Subjective Overall Vision: High Contrast Distance Visual Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PC1DMF', 'description': '(Test Lens) omafilcon A Proclear 1-D multifocal lens'}, {'id': 'OG001', 'title': 'Air Optix MF', 'description': '(Control Lens) lotrafilcon B Air Optix Aqua Multifocal'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'spread': '16', 'groupId': 'OG000'}, {'value': '88', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}, {'type': 'SECONDARY', 'title': 'Subjective Vision Assessments: High Contrast Intermediate Visual Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PC1DMF', 'description': '(Test Lens) omafilcon A Proclear 1-D multifocal lens'}, {'id': 'OG001', 'title': 'Air Optix MF', 'description': '(Control Lens) lotrafilcon B Air Optix Aqua Multifocal'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'spread': '15', 'groupId': 'OG000'}, {'value': '85', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}, {'type': 'PRIMARY', 'title': 'Objective Vision Assessments: High Contrast Intermediate Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PC1DMF', 'description': '(Test Lens) omafilcon A Proclear 1-D multifocal lens'}, {'id': 'OG001', 'title': 'Air Optix MF', 'description': '(Control Lens) lotrafilcon B Air Optix Aqua Multifocal'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.', 'unitOfMeasure': 'logMAR units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}, {'type': 'PRIMARY', 'title': 'Objective Vision Assessments: High Contrast Near Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PC1DMF', 'description': '(Test Lens) omafilcon A Proclear 1-D multifocal lens'}, {'id': 'OG001', 'title': 'Air Optix MF', 'description': '(Control Lens) lotrafilcon B Air Optix Aqua Multifocal'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.', 'unitOfMeasure': 'logMAR units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}, {'type': 'SECONDARY', 'title': 'Subjective Vision Assessments: High Contrast Near Visual Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PC1DMF', 'description': '(Test Lens) omafilcon A Proclear 1-D multifocal lens'}, {'id': 'OG001', 'title': 'Air Optix MF', 'description': '(Control Lens) lotrafilcon B Air Optix Aqua Multifocal'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'spread': '18', 'groupId': 'OG000'}, {'value': '80', 'spread': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omafilcon A (PC 1-D MF) / Lotrafilcon B (AIR OPTIX MF)', 'description': 'Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).'}, {'id': 'FG001', 'title': 'Lotrafilcon B (AIR OPTIX MF) / Omafilcon A (PC 1-D MF)', 'description': 'Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment was open between 06FEB2012 and 28FEB2012', 'preAssignmentDetails': 'The subjects who are current contact lens wearers should attend the first visit wearing their habitual lenses and having worn them that day for at least 2 hours prior to the visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Population', 'description': 'Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-07', 'studyFirstSubmitDate': '2012-02-02', 'resultsFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2012-02-02', 'lastUpdatePostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-03', 'studyFirstPostDateStruct': {'date': '2012-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Vision Assessments: High Contrast Distance Visual Acuity', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.'}, {'measure': 'Objective Vision Assessments: High Contrast Intermediate Visual Acuity', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.'}, {'measure': 'Objective Vision Assessments: High Contrast Near Visual Acuity', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.'}], 'secondaryOutcomes': [{'measure': 'Subjective Overall Vision: High Contrast Distance Visual Quality', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.'}, {'measure': 'Subjective Vision Assessments: High Contrast Intermediate Visual Quality', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.'}, {'measure': 'Subjective Vision Assessments: High Contrast Near Visual Quality', 'timeFrame': 'After 1 hour of lens wear', 'description': 'Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contact lenses'], 'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.', 'detailedDescription': 'The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the nondominant eye compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between 40 and 65 years of age (inclusive)\n* Require a reading addition of +1.25 to +2.50D (inclusive)\n* Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)\n* Spectacle cylinder less than or equal to 0.75D in both eyes.\n* Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)\n* Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)\n* Have a minimum 2 weeks soft contact lens experience\n* Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study)\n* Able to read, comprehend and sign an informed consent\n* Willing to comply with the wear and study visit schedule\n* Monocular best-corrected distance visual acuity ≥ 20/25 in each eye\n* No gas permeable contact lens wear for 1 month prior to the study\n\nExclusion Criteria:\n\nTo be eligible for the study, each candidate must not present with any of the following\n\n* Any active corneal infection, injury, inflammation, or ocular abnormality\n* Systemic or ocular allergies, which might interfere with contact lens wear\n* Systemic disease, which might interfere with contact lens wear\n* Ocular disease, which might interfere with contact lens wear\n* Pregnant or lactating\n* Strabismus/amblyopia\n* Habitually uncorrected anisometropia greater than or equal to 2.00 D\n* Subjects who have undergone corneal refractive surgery\n* Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear'}, 'identificationModule': {'nctId': 'NCT01526902', 'briefTitle': 'Proclear 1-D Multifocal Nondispensing Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'Proclear 1-D Multifocal Nondispensing Study', 'orgStudyIdInfo': {'id': 'CV-12-02A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'omafilcon A / PC 1-D MF', 'description': 'omafilcon A (PC 1-D MF) / lotrafilcon B (AIR OPTIX MF)\n\nSubjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.', 'interventionNames': ['Device: omafilcon A / PC 1-D MF', 'Device: lotrafilcon B / Air Optix MF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lotrafilcon B / Air Optix MF', 'description': 'lotrafilcon B (AIR OPTIX MF) / omafilcon A (PC 1-D MF)\n\nSubjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.', 'interventionNames': ['Device: omafilcon A / PC 1-D MF', 'Device: lotrafilcon B / Air Optix MF']}], 'interventions': [{'name': 'omafilcon A / PC 1-D MF', 'type': 'DEVICE', 'otherNames': ['Proclear Multifocal daily wear soft contact lenses'], 'description': 'Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.', 'armGroupLabels': ['lotrafilcon B / Air Optix MF', 'omafilcon A / PC 1-D MF']}, {'name': 'lotrafilcon B / Air Optix MF', 'type': 'DEVICE', 'otherNames': ['Air OPtix Aqua Multifocal extended wear soft contact lenses'], 'description': 'Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses', 'armGroupLabels': ['lotrafilcon B / Air Optix MF', 'omafilcon A / PC 1-D MF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Clinical Optics Research Lab, Indiana University,', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}], 'overallOfficials': [{'name': 'Peter Kollbaum, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}