Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT00584727
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2007-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '904-443-3088', 'title': 'Kurt Moody, OD, FAAO', 'organization': 'Vistakon'}, 'certainAgreement': {'otherDetails': 'The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Senofilcon A/Alphafilcon A/Etafilcon A', 'description': 'First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Alphafilcon A/Etafilcon A/Senofilcon A', 'description': 'First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Etafilcon A/Senofilcon A/Alphafilcon A', 'description': 'First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Senofilcon A/Etafilcon A/Alphafilcon A', 'description': 'First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Alphafilcon A/Senofilcon A/Etafilcon A', 'description': 'First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Etafilcon A/Alphafilcon A/Senofilcon A', 'description': 'First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A Toric'}, {'id': 'OG001', 'title': 'Alphafilcon A Toric'}, {'id': 'OG002', 'title': 'Etafilcon A Sphere'}], 'classes': [{'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere by having more eyes see 20/20', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '15-20 minutes', 'description': 'Number of eyes with Distance Visual Acuity 20/20 or better', 'unitOfMeasure': 'Eyes with Snellen VA 20/20 or better', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol (n=88 subjects,176 eyes)'}, {'type': 'PRIMARY', 'title': 'Patient Reported Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A Toric'}, {'id': 'OG001', 'title': 'Alphafilcon A Toric'}, {'id': 'OG002', 'title': 'Etafilcon A Sphere'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2845', 'spread': '0.098', 'groupId': 'OG000'}, {'value': '0.1332', 'spread': '0.098', 'groupId': 'OG001'}, {'value': '-0.4310', 'spread': '0.097', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.7155', 'ciLowerLimit': '0.3625', 'ciUpperLimit': '0.7155', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1334', 'estimateComment': 'Mean difference was senofilcon A toric minus etafilcon A sphere.', 'groupDescription': 'Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '15-20 minutes', 'description': 'A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. \\>0=greater vision, \\<0=lesser vision.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol (n=88)'}, {'type': 'PRIMARY', 'title': 'Lens Orientation Within 5 Degrees', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A Toric'}, {'id': 'OG001', 'title': 'Alphafilcon A Toric'}], 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2161', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Aletrnative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 minute', 'description': 'Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.', 'unitOfMeasure': 'degrees', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)'}, {'type': 'PRIMARY', 'title': 'Lens Stability Within 5 Degrees', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A Toric'}, {'id': 'OG001', 'title': 'Alphafilcon A Toric'}], 'classes': [{'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1328', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 minute', 'description': 'Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.', 'unitOfMeasure': 'degrees', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol (n=88 subjects, 176 eyes)'}, {'type': 'PRIMARY', 'title': 'Patient Reported Comfort.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A Toric'}, {'id': 'OG001', 'title': 'Alphafilcon A Toric'}, {'id': 'OG002', 'title': 'Etafilcon A Sphere'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1425', 'spread': '0.1034', 'groupId': 'OG000'}, {'value': '-0.3464', 'spread': '0.1035', 'groupId': 'OG001'}, {'value': '0.2176', 'spread': '0.1028', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.4890', 'ciLowerLimit': '0.1529', 'ciUpperLimit': '0.4890', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1393', 'estimateComment': 'Mean difference was senofilcon A toric minus alphafilcon A toric', 'groupDescription': 'Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '15-20 minutes', 'description': 'A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \\>0=comfortable, \\<0=uncomfortable', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol (n=88)'}, {'type': 'PRIMARY', 'title': 'Patient Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A Toric'}, {'id': 'OG001', 'title': 'Alphafilcon A Toric'}, {'id': 'OG002', 'title': 'Etafilcon A Sphere'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'end of study', 'description': 'This outcome measures which lens the subjects preferred to wear.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes participants who completed the study per protocol (n=88)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Senofilcon A/Alphafilcon A/Etafilcon A', 'description': 'First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses'}, {'id': 'FG001', 'title': 'Alphafilcon A/Etafilcon A/Senofilcon A', 'description': 'First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses'}, {'id': 'FG002', 'title': 'Etafilcon A/Senofilcon A/Alphafilcon A', 'description': 'First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses'}, {'id': 'FG003', 'title': 'Senofilcon A/Etafilcon A/Alphafilcon A', 'description': 'First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses'}, {'id': 'FG004', 'title': 'Alphafilcon A/Senofilcon A/Etafilcon A', 'description': 'First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere'}, {'id': 'FG005', 'title': 'Etafilcon A/Alphafilcon A/Senofilcon A', 'description': 'First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Discontinuation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Completed Population', 'description': 'Only participants that completed the study are included (n=88)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '5.96', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', '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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2007-12-20', 'resultsFirstSubmitDate': '2008-12-05', 'studyFirstSubmitQcDate': '2007-12-31', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-22', 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': '15-20 minutes', 'description': 'Number of eyes with Distance Visual Acuity 20/20 or better'}, {'measure': 'Patient Reported Vision', 'timeFrame': '15-20 minutes', 'description': 'A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. \\>0=greater vision, \\<0=lesser vision.'}, {'measure': 'Lens Orientation Within 5 Degrees', 'timeFrame': '1 minute', 'description': 'Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.'}, {'measure': 'Lens Stability Within 5 Degrees', 'timeFrame': '1 minute', 'description': 'Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.'}, {'measure': 'Patient Reported Comfort.', 'timeFrame': '15-20 minutes', 'description': 'A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \\>0=comfortable, \\<0=uncomfortable'}, {'measure': 'Patient Preference', 'timeFrame': 'end of study', 'description': 'This outcome measures which lens the subjects preferred to wear.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['astigmatism', 'visual acuity', 'fit', 'comfort', 'satisfaction', 'contact lens'], 'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric and a spherical contact lens currently available in market, specifically with regards to the fit and visual acuity as well as the comfort, vision and satisfaction while in the practitioner's office. Approximately 2 hours duration.", 'detailedDescription': 'Non-dispensing, single-masked (subject-masked), randomised, controlled study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed).\n2. be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy\n3. have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.\n4. be able and willing to adhere to the instructions set forth in the protocol.\n5. agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.\n6. have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes\n7. have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.\n8. be in good general health, based on his/her knowledge.\n9. read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.\n\nExclusion Criteria:\n\n1. The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.\n2. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.\n3. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).\n4. Slit lamp findings that would contraindicate contact lens wear such as:\n\n * Pathological dry eye or associated findings\n * Pterygium or corneal scars within the visual axis\n * Neovascularization \\>1mm in from the limbus\n * History of giant papillary conjunctivitis (GPC) worse than Grade 2\n * Anterior uveitis or iritis (past or present)\n * Seborrhoeic eczema, seborrhoeic conjunctivitis\n5. A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.\n6. A known history of corneal hypoesthesia (reduced corneal sensitivity.)\n7. Aphakia, keratoconus or a highly irregular cornea.\n8. Current pregnancy or lactation (to the best of the subject's knowledge).\n9. Active participation in another clinical study at any time during this study."}, 'identificationModule': {'nctId': 'NCT00584727', 'briefTitle': 'In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'Evaluation of Fit and Visual Acuity of the Cypress Toric Lens in Two Phases: Part A: A Non-Dispensing Comparison to SofLens66® Toric and Acuvue® 2', 'orgStudyIdInfo': {'id': 'CR-0714A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'senofilcon A/alphafilcon A/etafilcon A', 'description': 'First intervention:senofilcon A toric contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses', 'interventionNames': ['Device: senofilcon A toric contact lens', 'Device: alphafilcon A toric', 'Device: etafilcon A sphere']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'alphafilcon A/etafilcon A/senofilcon A', 'description': 'First intervention: alphafilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: senofilcon A toric contact lenses', 'interventionNames': ['Device: senofilcon A toric contact lens', 'Device: alphafilcon A toric', 'Device: etafilcon A sphere']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'etafilcon A/senofilcon A/alphafilcon A', 'description': 'First intervention: etafilcon A sphere contact lenses Second intervention:senofilcon A toric contact lenses Third intervention: alphafilcon A toric contact lenses', 'interventionNames': ['Device: senofilcon A toric contact lens', 'Device: alphafilcon A toric', 'Device: etafilcon A sphere']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'senofilcon A/etafilcon A/alphafilcon A', 'description': 'First intervention: senofilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: alphafilcon A toric contact lenses', 'interventionNames': ['Device: senofilcon A toric contact lens', 'Device: alphafilcon A toric', 'Device: etafilcon A sphere']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'alphafilcon A/senofilcon A/etafilcon A', 'description': 'First intervention: alphafilcon A toric contact lenses Second intervention: senofilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses', 'interventionNames': ['Device: senofilcon A toric contact lens', 'Device: alphafilcon A toric', 'Device: etafilcon A sphere']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'etafilcon A/alphafilcon A/senofilcon A', 'description': 'First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses', 'interventionNames': ['Device: senofilcon A toric contact lens', 'Device: alphafilcon A toric', 'Device: etafilcon A sphere']}], 'interventions': [{'name': 'senofilcon A toric contact lens', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['alphafilcon A/etafilcon A/senofilcon A', 'alphafilcon A/senofilcon A/etafilcon A', 'etafilcon A/alphafilcon A/senofilcon A', 'etafilcon A/senofilcon A/alphafilcon A', 'senofilcon A/alphafilcon A/etafilcon A', 'senofilcon A/etafilcon A/alphafilcon A']}, {'name': 'alphafilcon A toric', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['alphafilcon A/etafilcon A/senofilcon A', 'alphafilcon A/senofilcon A/etafilcon A', 'etafilcon A/alphafilcon A/senofilcon A', 'etafilcon A/senofilcon A/alphafilcon A', 'senofilcon A/alphafilcon A/etafilcon A', 'senofilcon A/etafilcon A/alphafilcon A']}, {'name': 'etafilcon A sphere', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['alphafilcon A/etafilcon A/senofilcon A', 'alphafilcon A/senofilcon A/etafilcon A', 'etafilcon A/alphafilcon A/senofilcon A', 'etafilcon A/senofilcon A/alphafilcon A', 'senofilcon A/alphafilcon A/etafilcon A', 'senofilcon A/etafilcon A/alphafilcon A']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jason Chin, O.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'James Fujimoto, O.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Weslie Hamada, OlD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arthur T. Kobayashi, O.D., Inc.'}, {'name': 'Dennis Kuwuabara, O.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Care Associates of Hawaii'}, {'name': 'Mark Nakano, O.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mark E. Nakano Optometric Corp.'}, {'name': 'Ikuko Sugimoto, O.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kevin Rosin, O.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drs. Farkas, Kassalow, Resnick & Associates'}, {'name': 'Jennifer Kao, O.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Foresight Regulatory Strategies, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Kurt Moody, OD, FAAO./ Manager, Clinical Research', 'oldOrganization': 'Vistakon'}}}}