Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00584220
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2007-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear
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': {'email': 'kmoody1@its.jnj.com', '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', 'description': 'senofilcon A toric silicone hydrogel contact lenses worn', 'otherNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Alphafilcon A', 'description': 'alphafilcon A toric hydrogel contact lenses worn', 'otherNumAtRisk': 96, 'otherNumAffected': 0, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Reported Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A Toric', 'description': 'contact lenses'}, {'id': 'OG001', 'title': 'Alphafilcon A Toric', 'description': 'contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'spread': '0.795', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.788', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 week', 'description': 'A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score \\>0 then greater vision, if \\<0 then lesser vision.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes only participants who completed the study per protocol and had no missing data.'}, {'type': 'PRIMARY', 'title': 'Subject Reported Lens Comfort.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Senofilcon A Toric', 'description': 'contact lenses'}, {'id': 'OG001', 'title': 'Alphafilcon A Toric', 'description': 'contact lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '0.37', 'spread': '0.730', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.723', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '1 week', 'description': 'A weighted combined score of one week and two week data 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 estimates for senofilcon A and alphafilcon A, respectively. Interpretation is \\>0 indicates comfortable and \\<0 indicates uncomfortable.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes only participants who completed the study per protocol and had no missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Senofilcon A / Alphafilcon A', 'description': 'senofilcon A toric silicone hydrogel contact lenses worn first, then alphafilcon A toric hydrogel contact lenses worn second'}, {'id': 'FG001', 'title': 'Alphafilcon A / Senofilcon A', 'description': 'alphafilcon A toric hydrogel contact lenses worn first, then senofilcon A toric silicone hydrogel contact lenses worn second'}], 'periods': [{'title': 'First Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of those 96 enrolled subjects in the study, 7 did not meet the study eligibility criteria and 1 did not receive the study lenses. One enrolled subject was discontinued from the study leaving n=87 who completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'Subjects who enrolled and completed the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '5.98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline summary was conducted on enrolled subjects who completed the study.'}}, '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': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2007-12-20', 'resultsFirstSubmitDate': '2009-08-21', 'studyFirstSubmitQcDate': '2007-12-31', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-28', 'studyFirstPostDateStruct': {'date': '2008-01-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Reported Vision', 'timeFrame': '1 week', 'description': 'A weighted combined score of one week and two week data calculated from individual vision-related questions asked on a 1-5 scale, 1 = most negative response to 5 = most positive, was used to derive vision outcomes. The analysis shows the outcome for both senofilcon A and alphafilcon A. If score \\>0 then greater vision, if \\<0 then lesser vision.'}, {'measure': 'Subject Reported Lens Comfort.', 'timeFrame': '1 week', 'description': 'A weighted combined score of one week and two week data 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 estimates for senofilcon A and alphafilcon A, respectively. Interpretation is \\>0 indicates comfortable and \\<0 indicates uncomfortable.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Astigmatism', 'vision', 'comfort', 'satisfaction', 'contact lenses'], '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 contact lens currently available in market, specifically with regards to the comfort and vision after two weeks of use.', 'detailedDescription': 'Dispensing, single-masked (subject-masked), randomized, 2-visit controlled study of two-weeks duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: Prior to being considered eligible to participate in this study, subjects MUST\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': 'NCT00584220', 'briefTitle': 'Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'officialTitle': 'Evaluation of Fit and Visual Acuity of the Investigational Toric Lens in Two Phases: Part B: A Dispensing Cross-over Comparison to SofLens66 Toric', 'orgStudyIdInfo': {'id': 'CR-0714B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'senofilcon A toric / alphafilcon A toric', 'description': 'senofilcon A toric contact lenses worn daily during the first period, then alphafilcon A toric contact lenses worn daily during the second period', 'interventionNames': ['Device: senofilcon A toric', 'Device: alphafilcon A toric']}, {'type': 'OTHER', 'label': 'alphafilcon A toric / senofilcon A toric', 'description': 'alphafilcon A toric contact lenses worn daily during the first period, then senofilcon A toric contact lenses worn daily during the second period', 'interventionNames': ['Device: senofilcon A toric', 'Device: alphafilcon A toric']}], 'interventions': [{'name': 'senofilcon A toric', 'type': 'DEVICE', 'description': 'contact lens', 'armGroupLabels': ['alphafilcon A toric / senofilcon A toric', 'senofilcon A toric / alphafilcon A toric']}, {'name': 'alphafilcon A toric', 'type': 'DEVICE', 'otherNames': ['SofLens66 Toric'], 'description': 'contact lens', 'armGroupLabels': ['alphafilcon A toric / senofilcon A toric', 'senofilcon A toric / alphafilcon A toric']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jason Chin, O.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'James Fujimoto, O.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Weslie Hamada, O.D.', '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', 'affiliation': 'Unaffilliated'}, {'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'}}}}