Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-28 @ 10:09 PM
Study NCT ID:
NCT00813761
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2008-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems
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': 'kcanava2@its.jnj.com', 'phone': '1-904-443-1474', 'title': 'Kristy Canavan, OD', 'organization': 'Vistakon'}, 'certainAgreement': {'otherDetails': 'Written consent of the sponsor is required for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '02Optix CL and ReNu MPS', 'description': 'O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution', 'otherNumAtRisk': 121, 'otherNumAffected': 0, 'seriousNumAtRisk': 121, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Proclear CL and ReNu MPS', 'description': 'Proclear contact lens and ReNu MultiPlus Multi-Purpose', 'otherNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '02Optix CL and Clear Care LCS', 'description': 'O2Optix contact lens and Clear Care lens care solution', 'otherNumAtRisk': 115, 'otherNumAffected': 0, 'seriousNumAtRisk': 115, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Proclear CL and Clear Care LCS', 'description': 'Proclear contact lens and Clear Care lens care solution', 'otherNumAtRisk': 107, 'otherNumAffected': 0, 'seriousNumAtRisk': 107, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Viral Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Daily Wear Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care Lens Cleaning Solution (LCS)', 'description': 'All subjects assigned to Clear Care LCS'}, {'id': 'OG001', 'title': 'ReNU Multi Purpose Solution (MPS)', 'description': 'All subjects assigned to ReNU MPS'}], 'classes': [{'categories': [{'measurements': [{'value': '13.57', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '13.30', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Average hours per day that contact lens were worn.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Average Daily Comfortable Wear Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '11.96', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '11.39', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Average hours per day that contact lens were worn comfortably.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Lens Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '8.63', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '8.25', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Frequency of Eye Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Frequency of Daily Lens Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Frequency of Eye Burning/Stinging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Frequency of Itching', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Frequency of Tearing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Average Corneal Fluorescein Type Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.36', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Average Corneal Fluorescein Staining Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Limbal Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.44', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Bulbar Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Lower Tarsal Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Upper Tarsal Redness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Tarsal Roughness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '388', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'OG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}], 'classes': [{'categories': [{'measurements': [{'value': '0.75', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency \\& superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Subjects included in analysis were those who completed the study and had complete data available for statistical analysis.'}, {'type': 'SECONDARY', 'title': 'Intensity of Physiological Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS (Stainers)', 'description': "Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}, {'id': 'OG001', 'title': 'Clear Care LCS (Non-Stainers)', 'description': "Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}, {'id': 'OG002', 'title': 'ReNU MPS (Stainers)', 'description': "ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}, {'id': 'OG003', 'title': 'ReNU MPS (Non-Stainers)', 'description': "ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}], 'classes': [{'title': 'Intensity of Discomfort/Pain', 'categories': [{'measurements': [{'value': '2.00', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '2.48', 'spread': '1.09', 'groupId': 'OG002'}, {'value': '2.24', 'spread': '1.17', 'groupId': 'OG003'}]}]}, {'title': 'Intensity of Burning/Stinging', 'categories': [{'measurements': [{'value': '2.24', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '2.35', 'spread': '1.09', 'groupId': 'OG002'}, {'value': '1.76', 'spread': '1.00', 'groupId': 'OG003'}]}]}, {'title': 'Intensity of Dryness', 'categories': [{'measurements': [{'value': '2.20', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '2.69', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '2.40', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '2.25', 'spread': '1.14', 'groupId': 'OG003'}]}]}, {'title': 'Intensity of Itching', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '2.24', 'spread': '1.23', 'groupId': 'OG002'}, {'value': '1.67', 'spread': '0.84', 'groupId': 'OG003'}]}]}, {'title': 'Intensity of Tearing', 'categories': [{'measurements': [{'value': '2.00', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '1.61', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '2.38', 'spread': '1.04', 'groupId': 'OG002'}, {'value': '1.73', 'spread': '0.79', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible to "Solution Induced Corneal Staining (SICS)". These measures are related to intensity of outcomes, i.e. discomfort, burning, dryness, etc. with lower scores being better on a scale of 1-5.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification."}, {'type': 'SECONDARY', 'title': 'Wearing Time and Comfortable Wearing Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS (Stainers)', 'description': "Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}, {'id': 'OG001', 'title': 'Clear Care LCS (Non-Stainers)', 'description': "Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}, {'id': 'OG002', 'title': 'ReNU MPS (Stainers)', 'description': "ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}, {'id': 'OG003', 'title': 'ReNU MPS (Non-Stainers)', 'description': "ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}], 'classes': [{'title': 'Average Wearing Time', 'categories': [{'measurements': [{'value': '14.06', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '13.63', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '13.49', 'spread': '2.67', 'groupId': 'OG002'}, {'value': '13.33', 'spread': '2.28', 'groupId': 'OG003'}]}]}, {'title': 'Average Comfortable Wearing Time', 'categories': [{'measurements': [{'value': '12.42', 'spread': '3.17', 'groupId': 'OG000'}, {'value': '11.93', 'spread': '3.47', 'groupId': 'OG001'}, {'value': '11.35', 'spread': '3.35', 'groupId': 'OG002'}, {'value': '11.75', 'spread': '3.67', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Average wearing time and average comfortable wearing time.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported per this stratification."}, {'type': 'SECONDARY', 'title': 'Physiological Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clear Care LCS (Stainers)', 'description': "Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}, {'id': 'OG001', 'title': 'Clear Care LCS (Non-Stainers)', 'description': "Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}, {'id': 'OG002', 'title': 'ReNU MPS (Stainers)', 'description': "ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}, {'id': 'OG003', 'title': 'ReNU MPS (Non-Stainers)', 'description': "ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'."}], 'classes': [{'title': 'Corneal Staining', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.52', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '0.32', 'spread': '0.38', 'groupId': 'OG003'}]}]}, {'title': 'Limbal Hyperemia', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.46', 'spread': '0.58', 'groupId': 'OG002'}, {'value': '0.43', 'spread': '0.51', 'groupId': 'OG003'}]}]}, {'title': 'Bulbar Hyperemia', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '0.53', 'spread': '0.62', 'groupId': 'OG002'}, {'value': '0.52', 'spread': '0.59', 'groupId': 'OG003'}]}]}, {'title': 'Lower Tarsal Hyperemia', 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '0.59', 'spread': '0.61', 'groupId': 'OG003'}]}]}, {'title': 'Upper Tarsal Hyperemia', 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '0.60', 'groupId': 'OG002'}, {'value': '0.59', 'spread': '0.61', 'groupId': 'OG003'}]}]}, {'title': 'Tarsal Roughness', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.75', 'groupId': 'OG001'}, {'value': '0.90', 'spread': '0.77', 'groupId': 'OG002'}, {'value': '0.84', 'spread': '0.89', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Physiological findings are done through a slit lamp examination and are known as biomicroscopy measurements. Measures are given in terms of average score with a minimum of zero and a worse grade the higher the value with a range of 0 to 4, (tarsal roughness is 0-7 scale).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All subjects, enrolled, randomized, and completed the study. Subjects where identified as 'stainers' or 'non-stainers' and outcomes were reported by this stratification."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '02Optix CL and ReNu MPS', 'description': 'O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution'}, {'id': 'FG001', 'title': 'Proclear CL and ReNu MPS', 'description': 'Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution'}, {'id': 'FG002', 'title': '02Optix CL and Clear Care LCS', 'description': 'O2Optix contact lens and Clear Care lens care solution'}, {'id': 'FG003', 'title': 'Proclear CL and Clear Care LCS', 'description': 'Proclear contact lens and Clear Care lens care solution'}], 'periods': [{'title': 'Phase 1 (Baseline to 4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '115'}, {'groupId': 'FG003', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'poor vision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'poor comfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Phase 2 (4 Weeks to 24 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '100'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '105'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '94'}, {'groupId': 'FG003', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Poor vision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Poor comfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Randomization strata filled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited in both the US and UK and were screened, randomized, and assigned to a study arm.', 'preAssignmentDetails': 'A total of 473 subjects were attempted to be enrolled. There were 27 disqualified, 2 due to incorrect care system, 1 due to non-compliance, and 24 due to non-compliance from investigator, leaving 446 subjects recruited to participate.Of those remaining, 21 failed to meet inclusion or were excluded for a total of 425 subjects who started the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '425', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clear Care LCS', 'description': 'Subjects assigned to Clear Care lens care solution'}, {'id': 'BG001', 'title': 'ReNU MPS', 'description': 'Subjects assigned to ReNU multi purpose solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '33.4', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '33.6', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 473}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2009-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2008-12-17', 'resultsFirstSubmitDate': '2011-10-24', 'studyFirstSubmitQcDate': '2008-12-22', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-10-24', 'studyFirstPostDateStruct': {'date': '2008-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Daily Wear Time', 'timeFrame': '24 weeks', 'description': 'Average hours per day that contact lens were worn.'}, {'measure': 'Average Daily Comfortable Wear Time', 'timeFrame': '24 weeks', 'description': 'Average hours per day that contact lens were worn comfortably.'}, {'measure': 'Lens Comfort', 'timeFrame': '24 weeks', 'description': 'Lens comfort at time of month 6 visit, using a scale of 0 to 10, where 10=excellent.'}, {'measure': 'Frequency of Eye Discomfort', 'timeFrame': '24 weeks', 'description': 'Subjective measure of typical daily eye discomfort reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.'}, {'measure': 'Frequency of Daily Lens Dryness', 'timeFrame': '24 weeks', 'description': 'Subjective measure of typical daily contact lens dryness reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.'}, {'measure': 'Frequency of Eye Burning/Stinging', 'timeFrame': '24 weeks', 'description': 'Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.'}, {'measure': 'Frequency of Itching', 'timeFrame': '24 weeks', 'description': 'Subjective measure of typical daily eye burning and stinging reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.'}, {'measure': 'Frequency of Tearing', 'timeFrame': '24 weeks', 'description': 'Subjective measure of typical daily tearing related to lens wear reported at month 6 visit using a scale of 0 to 3. 0=Never, 1=Infrequently, 2=Frequently, 3=Constantly.'}, {'measure': 'Average Corneal Fluorescein Type Staining', 'timeFrame': '24 weeks', 'description': 'staining measured over five sectors of the cornea and classified as a type of staining on a scale of 0 to 4. 0=None, 1=Micropunctate, 2=Macropunctate, 3=Coalesced Macropunctate, 4=Patch.'}, {'measure': 'Average Corneal Fluorescein Staining Area', 'timeFrame': '24 weeks', 'description': 'corneal staining measured over 5 areas, averaged, and graded as a single score average on a scale of 0 to 10, 0=0%, 1=10%, 2=20%, 3=30%, 4=40%, 5=50%, 6=60%, 7=70%, 8=80%, 9=90%, 10=100%.'}, {'measure': 'Limbal Redness', 'timeFrame': '24 weeks', 'description': 'Redness at the transition zone between the white of the eye and the clear window of the eye, the cornea, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe'}, {'measure': 'Bulbar Redness', 'timeFrame': '24 weeks', 'description': 'Redness of the blood vessels in the tissues overlaying the white of the eye, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe'}, {'measure': 'Lower Tarsal Redness', 'timeFrame': '24 weeks', 'description': 'Redness of the blood vessels in the inner lining of the lower eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe'}, {'measure': 'Upper Tarsal Redness', 'timeFrame': '24 weeks', 'description': 'Redness of the blood vessels in the inner lining of the upper eyelid, on a scale of 0 to 4. 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe'}, {'measure': 'Tarsal Roughness', 'timeFrame': '24 weeks', 'description': 'The roughness of the inner lining of the eyelids, measured on a 0 to 7 scale. 0=Smooth, 1=Slightly uneven, 2=Uneven surface, 3=Uneven surface with loss of transparency \\& superficial vessels, 4=Small papillae, poor transparency, 5=Papillae greater than 0.5mm in size, no transparency, 6=Papillae greater than 0.5mm in size, vessels inside papillae, 7=Large papillae'}], 'secondaryOutcomes': [{'measure': 'Intensity of Physiological Outcomes', 'timeFrame': '24 weeks', 'description': 'Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible to "Solution Induced Corneal Staining (SICS)". These measures are related to intensity of outcomes, i.e. discomfort, burning, dryness, etc. with lower scores being better on a scale of 1-5.'}, {'measure': 'Wearing Time and Comfortable Wearing Time', 'timeFrame': '24 weeks', 'description': 'Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Average wearing time and average comfortable wearing time.'}, {'measure': 'Physiological Responses', 'timeFrame': '24 weeks', 'description': 'Mean of physiological outcomes for those subjects who are identified as susceptible versus non-susceptible for "Solution Induced Corneal Staining (SICS)". Physiological findings are done through a slit lamp examination and are known as biomicroscopy measurements. Measures are given in terms of average score with a minimum of zero and a worse grade the higher the value with a range of 0 to 4, (tarsal roughness is 0-7 scale).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two marketed contact lens care solutions in regards to comfort and ocular health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 18 years old.\n* Signed Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.\n* Require a visual correction in both eyes (monovision allowed but not monofit).\n* Have a contact lens spherical distance requirement between +6.00D and -9.00D in both eyes.\n* Astigmatism of 1.00D or less in the better eye and 1.50D or less in the other eye.\n* Be correctable to a visual acuity of 20/30 (6/9) or better in each eye.\n* Have normal eyes with no evidence of abnormality or disease.\n\nExclusion Criteria:\n\n* Requires concurrent ocular medication.\n* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.\n* Clinically significant corneal edema, corneal vascularisation, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.\n* Worn lenses on an extended wear basis in the last 3 months.\n* Diabetic.\n* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).\n* Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.\n* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.\n* Abnormal lacrimal secretions.'}, 'identificationModule': {'nctId': 'NCT00813761', 'briefTitle': 'Clinical Evaluation of the Long-Term Effects of Contact Lens Care Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-4522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '02Optix CL and ReNu MPS with SICS', 'description': 'O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution', 'interventionNames': ['Device: O2Optix contact lens', 'Device: ReNu MultiPlus Multi-Purpose Solution']}, {'type': 'OTHER', 'label': 'Proclear CL and ReNu MPS with SICS', 'description': 'Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution', 'interventionNames': ['Device: Proclear contact lens', 'Device: ReNu MultiPlus Multi-Purpose Solution']}, {'type': 'OTHER', 'label': '02Optix CL and Clear Care LCS with SICS', 'description': 'O2Optix contact lens and Clear Care lens care solution subject', 'interventionNames': ['Device: O2Optix contact lens', 'Device: Clear Care Cleaning and Disinfecting Solution']}, {'type': 'OTHER', 'label': 'Proclear CL and Clear Care LCS with SICS', 'description': 'Proclear contact lens and Clear Care lens care solution', 'interventionNames': ['Device: Proclear contact lens', 'Device: Clear Care Cleaning and Disinfecting Solution']}, {'type': 'OTHER', 'label': '02Optix CL and ReNu MPS without SICS', 'description': 'O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution', 'interventionNames': ['Device: O2Optix contact lens', 'Device: ReNu MultiPlus Multi-Purpose Solution']}, {'type': 'OTHER', 'label': 'Proclear CL and ReNu MPS without SICS', 'description': 'Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution', 'interventionNames': ['Device: Proclear contact lens', 'Device: ReNu MultiPlus Multi-Purpose Solution']}, {'type': 'OTHER', 'label': '02Optix CL and Clear Care LCS without SICS', 'description': 'O2Optix contact lens and Clear Care lens care solution', 'interventionNames': ['Device: O2Optix contact lens', 'Device: Clear Care Cleaning and Disinfecting Solution']}, {'type': 'OTHER', 'label': 'Proclear CL and Clear Care LCS without SICS', 'description': 'Proclear contact lens and Clear Care lens care solution', 'interventionNames': ['Device: Proclear contact lens', 'Device: Clear Care Cleaning and Disinfecting Solution']}], 'interventions': [{'name': 'O2Optix contact lens', 'type': 'DEVICE', 'description': 'control contact lens to be worn daily for approximately 7 months for entire length of study.', 'armGroupLabels': ['02Optix CL and Clear Care LCS with SICS', '02Optix CL and Clear Care LCS without SICS', '02Optix CL and ReNu MPS with SICS', '02Optix CL and ReNu MPS without SICS']}, {'name': 'Proclear contact lens', 'type': 'DEVICE', 'description': 'control contact lens to be worn for entire length of study.', 'armGroupLabels': ['Proclear CL and Clear Care LCS with SICS', 'Proclear CL and Clear Care LCS without SICS', 'Proclear CL and ReNu MPS with SICS', 'Proclear CL and ReNu MPS without SICS']}, {'name': 'ReNu MultiPlus Multi-Purpose Solution', 'type': 'DEVICE', 'description': 'lens solution for overnight lens disinfection', 'armGroupLabels': ['02Optix CL and ReNu MPS with SICS', '02Optix CL and ReNu MPS without SICS', 'Proclear CL and ReNu MPS with SICS', 'Proclear CL and ReNu MPS without SICS']}, {'name': 'Clear Care Cleaning and Disinfecting Solution', 'type': 'DEVICE', 'description': 'lens solution for overnight lens disinfection', 'armGroupLabels': ['02Optix CL and Clear Care LCS with SICS', '02Optix CL and Clear Care LCS without SICS', 'Proclear CL and Clear Care LCS with SICS', 'Proclear CL and Clear Care LCS without SICS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.76954, 'lon': 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