Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-29 @ 8:52 AM
Study NCT ID:
NCT01912768
Status:
COMPLETED
Last Update Posted:
2015-07-09
First Post:
2013-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D006956', 'term': 'Hyperopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003263', 'term': 'Contact Lenses, Hydrophilic'}], 'ancestors': [{'id': 'D003261', 'term': 'Contact Lenses'}, {'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Clinical Project Lead, GCRA', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'An Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device. AEs are reported as pre-treatment and treatment-emergent.', 'description': 'AEs were collected for the duration of the study (Dec 2013-May 2014). AEs were obtained as solicited and volunteered comments from subjects and as observations by the Investigator as outlined in the protocol. One subject was randomized but never received investigational product and was excluded from the safety dataset.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-treatment', 'description': 'All subjects who consented to participate in the study prior to exposure to investigational product', 'otherNumAtRisk': 362, 'otherNumAffected': 0, 'seriousNumAtRisk': 362, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'FID 120947A', 'description': 'All subjects who were exposed to FID 120947A', 'otherNumAtRisk': 238, 'otherNumAffected': 0, 'seriousNumAtRisk': 238, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Renu Fresh', 'description': 'All subjects who were exposed to renu fresh', 'otherNumAtRisk': 113, 'otherNumAffected': 0, 'seriousNumAtRisk': 113, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 362, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 238, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Visibly Clean Lenses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'title': 'Day 7, n=236, 113', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000'}, {'value': '39.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, n=234, 112', 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '31.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, n=232, 110', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}, {'value': '32.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, n=229, 109', 'categories': [{'measurements': [{'value': '41.9', 'groupId': 'OG000'}, {'value': '33.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Crystalline Deposits by Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'title': 'Day 7, Type II, n=55,32', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}, {'value': '65.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Type III, n=55,32', 'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Type IV, n=55,32', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Type II, n=74, 37', 'categories': [{'measurements': [{'value': '70.3', 'groupId': 'OG000'}, {'value': '59.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Type III, n=74, 37', 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000'}, {'value': '16.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Type IV, n=74, 37', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}, {'value': '24.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Type II, n=73, 36', 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Type III, n=73, 36', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Type IV, n=73, 36', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Type II, n=69, 42', 'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000'}, {'value': '59.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Type III, n=69, 42', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '19.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Type IV, n=69, 42', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Film Deposits by Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'title': 'Day 7, Type II, n=114, 56', 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000'}, {'value': '58.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Type III, n=114, 56', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Type IV, n=114, 56', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Type II, n=125, 66', 'categories': [{'measurements': [{'value': '62.4', 'groupId': 'OG000'}, {'value': '62.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Type III, n=125, 66', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Type IV, n=125, 66', 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Type II, n=114, 63', 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}, {'value': '55.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Type III, n=114, 63', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Type IV, n=114, 63', 'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000'}, {'value': '36.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Type II, n=114, 59', 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000'}, {'value': '50.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Type III, n=114, 59', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Type IV, n=114, 59', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '35.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with film deposits in each treatment group, respectively, by visit.'}, {'type': 'PRIMARY', 'title': 'Average Residual Lens Lysozyme', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'categories': [{'measurements': [{'value': '70.2', 'spread': '192.1', 'groupId': 'OG000'}, {'value': '114.5', 'spread': '295.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30/Early Exit', 'description': 'Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.', 'unitOfMeasure': 'micrograms per lens', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all subjects with data at visit.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'title': 'Day 7, 2 Line Increase from Baseline, n=236, 112', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, 1 Line Increase from Baseline, n=236, 112', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, No Change from Baseline, n=236, 112', 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000'}, {'value': '99.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, 1 Line Decrease from Baseline, n=236, 112', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, 2 Line Decrease, n=236, 112', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, 2 Line Increase from Baseline, n=234, 112', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, 1 Line Increase from Baseline, n=234, 112', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, No Change from Baseline, n=234, 112', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000'}, {'value': '99.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, 1 Line Decrease from Baseline, n=234, 112', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, 2 Line Decrease from Baseline, n=234, 112', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, 2 Line Increase from Baseline, n=232, 110', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, 1 Line Increase from Baseline, n=232, 110', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, No Change from Baseline, n=232, 110', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000'}, {'value': '98.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, 1 Line Decrease from Baseline, n=232, 110', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, 2 Line Decrease from Baseline, n=232, 110', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, 2 Line Increase from Baseline, n=229, 109', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, 1 Line Increase from Baseline, n=229, 109', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, No Change from Baseline, n=229, 109', 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000'}, {'value': '98.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, 1 Line Decrease from Baseline, n=229, 109', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, 2 Line Decrease from Baseline, n=229, 109', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 0), Day 7, Day 30, Day 60, Day 90', 'description': 'Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.'}, {'type': 'PRIMARY', 'title': 'Average Lens Wear Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'title': 'Day 7, n=236, 113', 'categories': [{'measurements': [{'value': '12.9', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, n=234, 112', 'categories': [{'measurements': [{'value': '12.9', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, n=232, 110', 'categories': [{'measurements': [{'value': '13.0', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, n=229, 109', 'categories': [{'measurements': [{'value': '13.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.'}, {'type': 'PRIMARY', 'title': 'Number of Unscheduled Lens Replacements by Reason', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'title': 'Discomfort', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lost', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lens torn on eye', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lens torn while handling', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 90', 'description': 'A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.', 'unitOfMeasure': 'lenses', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects.'}, {'type': 'PRIMARY', 'title': 'Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'title': 'Day 7, Strongly Agree, n=236, 113', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Agree, n=236, 113', 'categories': [{'measurements': [{'value': '55.1', 'groupId': 'OG000'}, {'value': '50.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Undecided, n=236, 113', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Disagree, n=236, 113', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Strongly Disagree, n=236, 113', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Strongly Agree, n=234, 112', 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}, {'value': '24.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Agree, n=234, 112', 'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000'}, {'value': '51.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Undecided, n=234, 112', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Disagree, n=234, 112', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000'}, {'value': '16.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Strongly Disagree, n=234, 112', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Strongly Agree, n=232, 110', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '21.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Agree, n=232, 110', 'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000'}, {'value': '51.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Undecided, n=232, 110', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Disagree, n=232, 110', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Strongly Disagree, n=232, 110', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Strongly Agree, n=229, 109', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '23.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Agree, n=229, 109', 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000'}, {'value': '59.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Undecided, n=229, 109', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Disagree, n=229, 109', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Strongly Disagree, n=229, 109', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.'}, {'type': 'PRIMARY', 'title': 'Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'title': 'Day 7, Strongly Agree, n=236, 113', 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Agree, n=236, 113', 'categories': [{'measurements': [{'value': '57.2', 'groupId': 'OG000'}, {'value': '59.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Undecided, n=236, 113', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Disagree, n=236, 113', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Strongly Disagree, n=236, 113', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Strongly Agree, n=234, 112', 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Agree, n=234, 112', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '59.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Undecided, n=234, 112', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Disagree, n=234, 112', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Strongly Disagree, n=234, 112', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Strongly Agree, n=232, 110', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Agree, n=232, 110', 'categories': [{'measurements': [{'value': '62.1', 'groupId': 'OG000'}, {'value': '61.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Undecided, n=232, 110', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Disagree, n=232, 110', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Strongly Disagree, n=232, 110', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Strongly Agree, n=229, 109', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Agree, n=229, 109', 'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}, {'value': '63.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Undecided, n=229, 109', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Disagree, n=229, 109', 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Strongly Disagree, n=229, 109', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.'}, {'type': 'PRIMARY', 'title': 'Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'title': 'Day 7, Strongly Agree, n=236, 113', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}, {'value': '38.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Agree, n=236, 113', 'categories': [{'measurements': [{'value': '52.1', 'groupId': 'OG000'}, {'value': '47.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Undecided, n=236, 113', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Disagree, n=236, 113', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, Strongly Disagree, n=236, 113', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Strongly Agree, n=234, 112', 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Agree, n=234, 112', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000'}, {'value': '59.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Undecided, n=234, 112', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Disagree, n=234, 112', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, Strongly Disagree, n=234, 112', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Strongly Agree, n=232, 110', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '28.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Agree, n=232, 110', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '51.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Undecided, n=232, 110', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Disagree, n=232, 110', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, Strongly Disagree, n=232, 110', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Strongly Agree, n=229, 109', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '28.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Agree, n=229, 109', 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000'}, {'value': '56.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Undecided, n=229, 109', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Disagree, n=229, 109', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, Strongly Disagree, n=229, 109', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.'}, {'type': 'PRIMARY', 'title': 'Crystalline Deposit Area Covered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'title': 'Day 7, n=55, 32', 'categories': [{'measurements': [{'value': '12.5', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '18.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, n=74, 37', 'categories': [{'measurements': [{'value': '12.1', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '16.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, n=73, 36', 'categories': [{'measurements': [{'value': '13.0', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, n=69, 42', 'categories': [{'measurements': [{'value': '12.2', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.', 'unitOfMeasure': 'percentage of lens area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.'}, {'type': 'PRIMARY', 'title': 'Film Deposit Area Covered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'classes': [{'title': 'Day 7, n=114, 56', 'categories': [{'measurements': [{'value': '18.7', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '12.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 30, n=125, 66', 'categories': [{'measurements': [{'value': '18.9', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '20.5', 'spread': '14.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 60, n=114, 63', 'categories': [{'measurements': [{'value': '21.0', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 90, n=114, 59', 'categories': [{'measurements': [{'value': '17.3', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '20.9', 'spread': '14.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.', 'unitOfMeasure': 'percentage of lens area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with film deposits in each treatment group, respectively, by visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'FG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '239'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Randomized in error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 17 study centers located in the US.', 'preAssignmentDetails': 'Of the 362 enrolled, 10 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (352).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FID 120947A', 'description': 'Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'BG001', 'title': 'Renu Fresh', 'description': 'Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '35.3', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '34.8', 'spread': '11.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population includes all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-10', 'studyFirstSubmitDate': '2013-07-29', 'resultsFirstSubmitDate': '2015-05-26', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-26', 'studyFirstPostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Visibly Clean Lenses', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.'}, {'measure': 'Percentage of Subjects With Crystalline Deposits by Type', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.'}, {'measure': 'Percentage of Subjects With Film Deposits by Type', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.'}, {'measure': 'Average Residual Lens Lysozyme', 'timeFrame': 'Day 30/Early Exit', 'description': 'Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.'}, {'measure': 'Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change', 'timeFrame': 'Baseline (Day 0), Day 7, Day 30, Day 60, Day 90', 'description': 'Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.'}, {'measure': 'Average Lens Wear Time', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours.'}, {'measure': 'Number of Unscheduled Lens Replacements by Reason', 'timeFrame': 'Up to Day 90', 'description': 'A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.'}, {'measure': 'Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.'}, {'measure': 'Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.'}, {'measure': 'Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.'}, {'measure': 'Crystalline Deposit Area Covered', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.'}, {'measure': 'Film Deposit Area Covered', 'timeFrame': 'Day 7, Day 30, Day 60, Day 90', 'description': 'Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['contact lenses', 'contact lens solution', 'soft contact lenses'], 'conditions': ['Myopia', 'Astigmatism', 'Hyperopia', 'Refractive Error']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.', 'detailedDescription': 'Subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal eyes (other than correction for visual acuity);\n* Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;\n* Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;\n* Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;\n* Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;\n* History of intolerance or hypersensitivity to any component of the investigational products;\n* Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;\n* Moderate, severe, abnormal, or other ocular findings;\n* Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;\n* Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;\n* Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;\n* Ocular surgery within the last 12 months;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01912768', 'briefTitle': 'Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution', 'orgStudyIdInfo': {'id': 'C-13-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FID 120947A', 'description': 'FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days', 'interventionNames': ['Device: FID 120947A contact lens disinfecting solution', 'Device: Soft contact lenses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'renu fresh', 'description': 'Renu fresh multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days', 'interventionNames': ['Device: renu fresh multi-purpose solution', 'Device: Soft contact lenses']}], 'interventions': [{'name': 'FID 120947A contact lens disinfecting solution', 'type': 'DEVICE', 'otherNames': ['Clear Care® Plus'], 'description': 'Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses', 'armGroupLabels': ['FID 120947A']}, {'name': 'renu fresh multi-purpose solution', 'type': 'DEVICE', 'description': 'Commercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses', 'armGroupLabels': ['renu fresh']}, {'name': 'Soft contact lenses', 'type': 'DEVICE', 'description': 'Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.', 'armGroupLabels': ['FID 120947A', 'renu fresh']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Monica Studzinski, Lead CSM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}