Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-28 @ 12:27 PM
Study NCT ID:
NCT01055457
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2010-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vistakon Investigational Multi-purpose Contact Lens Care Solution.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'KCANAVA2@its.jnj.com', 'phone': '904-443-3500', 'title': 'Kristy Canavan, O.D.- PRINCIPAL RESEARCH OPTOMETRIST, Clin Ops', 'organization': 'Johson & Johnson Vision Care Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the duration of the study. Approximately 3 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Solution1 (Etafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Solution1 (Comfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Solution1 (Balafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.', 'otherNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Solution1 (Lotrafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Solution1 (Galyfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.', 'otherNumAtRisk': 41, 'otherNumAffected': 2, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Solution2 (Etafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Solution2 (Comfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.', 'otherNumAtRisk': 19, 'otherNumAffected': 1, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Solution2 (Balafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.', 'otherNumAtRisk': 19, 'otherNumAffected': 1, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Solution2 (Lotrafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Solution2 (Galyfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjunctivitis - Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Symptoms/ Complaints', 'notes': 'Symptoms and complaints requiring treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}], 'seriousEvents': [{'term': 'Vitreous Hemorrhage / Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Slit Lamp Findings (SLF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}, {'units': 'Subject eyes', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '36', 'groupId': 'OG007'}, {'value': '40', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Solution1 (Etafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'OG001', 'title': 'Solution1 (Comfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'OG002', 'title': 'Solution1 (Balafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'OG003', 'title': 'Solution1 (Lotrafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'OG004', 'title': 'Solution1 (Galyfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'OG005', 'title': 'Solution2 (Etafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'OG006', 'title': 'Solution2 (Comfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'OG007', 'title': 'Solution2 (Balafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'OG008', 'title': 'Solution2 (Lotrafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'OG009', 'title': 'Solution2 (Galyfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}], 'classes': [{'title': 'Edema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Corneal Neovascularization', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Corneal Staining', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}]}]}, {'title': 'Injection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}]}, {'title': 'Tarsal Abnormalities', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '9', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Other Findings', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months Post Lens Wear', 'description': 'Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.', 'unitOfMeasure': 'eyes (2 per subject)', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject eyes', 'denomUnitsSelected': 'Subject eyes', 'populationDescription': 'All subjects that completed the study.'}, {'type': 'PRIMARY', 'title': 'Distance Visual Acuity (LogMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '18', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}, {'value': '19', 'groupId': 'OG009'}]}, {'units': 'Subjects Eyes', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}, {'value': '76', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}, {'value': '36', 'groupId': 'OG007'}, {'value': '40', 'groupId': 'OG008'}, {'value': '38', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Solution1 (Etafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'OG001', 'title': 'Solution1 (Comfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'OG002', 'title': 'Solution1 (Balafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'OG003', 'title': 'Solution1 (Lotrafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'OG004', 'title': 'Solution1 (Galyfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'OG005', 'title': 'Solution2 (Etafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'OG006', 'title': 'Solution2 (Comfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'OG007', 'title': 'Solution2 (Balafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'OG008', 'title': 'Solution2 (Lotrafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'OG009', 'title': 'Solution2 (Galyfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}], 'classes': [{'title': '1-week', 'categories': [{'measurements': [{'value': '-0.033', 'spread': '0.0601', 'groupId': 'OG000'}, {'value': '-0.042', 'spread': '0.0630', 'groupId': 'OG001'}, {'value': '-0.037', 'spread': '0.0563', 'groupId': 'OG002'}, {'value': '-0.040', 'spread': '0.0665', 'groupId': 'OG003'}, {'value': '-0.029', 'spread': '0.0615', 'groupId': 'OG004'}, {'value': '-0.055', 'spread': '0.0580', 'groupId': 'OG005'}, {'value': '-0.033', 'spread': '0.0601', 'groupId': 'OG006'}, {'value': '-0.040', 'spread': '0.0540', 'groupId': 'OG007'}, {'value': '-0.045', 'spread': '0.0685', 'groupId': 'OG008'}, {'value': '-0.012', 'spread': '0.0619', 'groupId': 'OG009'}]}]}, {'title': '2-week', 'categories': [{'measurements': [{'value': '-0.045', 'spread': '0.0642', 'groupId': 'OG000'}, {'value': '-0.041', 'spread': '0.0663', 'groupId': 'OG001'}, {'value': '-0.047', 'spread': '0.0592', 'groupId': 'OG002'}, {'value': '-0.039', 'spread': '0.0649', 'groupId': 'OG003'}, {'value': '-0.037', 'spread': '0.0594', 'groupId': 'OG004'}, {'value': '-0.058', 'spread': '0.0585', 'groupId': 'OG005'}, {'value': '-0.045', 'spread': '0.0642', 'groupId': 'OG006'}, {'value': '-0.051', 'spread': '0.0625', 'groupId': 'OG007'}, {'value': '-0.031', 'spread': '0.0551', 'groupId': 'OG008'}, {'value': '-0.030', 'spread': '0.0595', 'groupId': 'OG009'}]}]}, {'title': '1-Month', 'categories': [{'measurements': [{'value': '-0.045', 'spread': '0.0623', 'groupId': 'OG000'}, {'value': '-0.042', 'spread': '0.0644', 'groupId': 'OG001'}, {'value': '-0.033', 'spread': '0.0658', 'groupId': 'OG002'}, {'value': '-0.040', 'spread': '0.0628', 'groupId': 'OG003'}, {'value': '-0.037', 'spread': '0.0595', 'groupId': 'OG004'}, {'value': '-0.068', 'spread': '0.0541', 'groupId': 'OG005'}, {'value': '-0.045', 'spread': '0.0623', 'groupId': 'OG006'}, {'value': '-0.026', 'spread': '0.0534', 'groupId': 'OG007'}, {'value': '-0.031', 'spread': '0.0626', 'groupId': 'OG008'}, {'value': '-0.032', 'spread': '0.0610', 'groupId': 'OG009'}]}]}, {'title': '3-Month', 'categories': [{'measurements': [{'value': '-0.045', 'spread': '0.0673', 'groupId': 'OG000'}, {'value': '-0.031', 'spread': '0.0609', 'groupId': 'OG001'}, {'value': '-0.039', 'spread': '0.0617', 'groupId': 'OG002'}, {'value': '-0.038', 'spread': '0.0607', 'groupId': 'OG003'}, {'value': '-0.031', 'spread': '0.0613', 'groupId': 'OG004'}, {'value': '-0.051', 'spread': '0.0668', 'groupId': 'OG005'}, {'value': '-0.045', 'spread': '0.0673', 'groupId': 'OG006'}, {'value': '-0.034', 'spread': '0.0567', 'groupId': 'OG007'}, {'value': '-0.014', 'spread': '0.0618', 'groupId': 'OG008'}, {'value': '-0.040', 'spread': '0.0614', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 3 Months Post Lens Wear', 'description': 'Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subjects Eyes', 'denomUnitsSelected': 'Subjects Eyes', 'populationDescription': 'All subjects that completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Solution1 (Etafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'FG001', 'title': 'Solution1 (Comfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'FG002', 'title': 'Solution1 (Balafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'FG003', 'title': 'Solution1 (Lotrafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'FG004', 'title': 'Solution1 (Galyfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.'}, {'id': 'FG005', 'title': 'Solution2 (Etafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'FG006', 'title': 'Solution2 (Comfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'FG007', 'title': 'Solution2 (Balafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'FG008', 'title': 'Solution2 (Lotrafilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}, {'id': 'FG009', 'title': 'Solution2 (Galyfilcon A)', 'description': 'Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '41'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '19'}, {'groupId': 'FG007', 'numSubjects': '19'}, {'groupId': 'FG008', 'numSubjects': '20'}, {'groupId': 'FG009', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '38'}, {'groupId': 'FG005', 'numSubjects': '15'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '18'}, {'groupId': 'FG008', 'numSubjects': '20'}, {'groupId': 'FG009', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Subject Disinterest', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Subject Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Discomfort', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 315 subjects were enrolled in this study. Of the enrolled subjects 20 did not meet the eligibility criteria and 295 subjects were randomized to treatment.Of the randomized subjects 16 were discontinued from the study, while 279 completed the study.', 'preAssignmentDetails': 'Allocation of subjects to the 5 contact lenses was fairly balanced ranging from 57 to 61 subjects per lens, while the allocation of subjects to solution was 2:1 for the test and control solution respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}, {'value': '295', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Solution 1 (Etafilcon A)', 'description': 'All subjects that were dispensed solution 1 and the etafilcon A lens.'}, {'id': 'BG001', 'title': 'Solution 1 (Comfilcon A)', 'description': 'All subjects that were dispensed solution 1 and the comfilcon A study lens.'}, {'id': 'BG002', 'title': 'Solution 1 (Balafilcon A)', 'description': 'All subjects that were dispensed solution 1 and the balafilcon A study lens.'}, {'id': 'BG003', 'title': 'Solution 1 (Lotrafilcon A)', 'description': 'All subjects that were dispensed solution 1 and the lotrafilcon A study lens.'}, {'id': 'BG004', 'title': 'Solution 1 (Galyfilcon A)', 'description': 'All subjects that were dispensed solution 1 and the galyfilcon A study lens.'}, {'id': 'BG005', 'title': 'Solution 2 (Etafilcon A)', 'description': 'All subjects that were dispensed solution 2 and etafilcon A study lens.'}, {'id': 'BG006', 'title': 'Solution 2 (Comfilcon A)', 'description': 'All subjects that were dispensed solution 2 and the comfilcon A study lens.'}, {'id': 'BG007', 'title': 'Solution 2 (Balafilcon A)', 'description': 'All subjects that were dispensed solution 2 and balafilcon A study lens.'}, {'id': 'BG008', 'title': 'Solution 2 (Lotrafilcon A)', 'description': 'All subjects that were dispensed solution 2 and the lotrafilcon A study lens.'}, {'id': 'BG009', 'title': 'Solution 2 (Galyfilcon A)', 'description': 'All subjects that were dispensed solution 2 and the galyfilcon A study lens.'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Solution 1(etafilcon A)', 'categories': [{'measurements': [{'value': '30.17', 'spread': '8.692', 'groupId': 'BG000'}, {'value': '31.58', 'spread': '9.459', 'groupId': 'BG001'}, {'value': '32.16', 'spread': '8.526', 'groupId': 'BG002'}, {'value': '29.45', 'spread': '9.333', 'groupId': 'BG003'}, {'value': '29.10', 'spread': '7.993', 'groupId': 'BG004'}, {'value': '32.48', 'spread': '7.845', 'groupId': 'BG005'}, {'value': '29.95', 'spread': '6.417', 'groupId': 'BG006'}, {'value': '34.26', 'spread': '8.738', 'groupId': 'BG007'}, {'value': '30.10', 'spread': '9.554', 'groupId': 'BG008'}, {'value': '32.15', 'spread': '8.079', 'groupId': 'BG009'}, {'value': '30.89', 'spread': '9.012', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}, {'value': '9', 'groupId': 'BG009'}, {'value': '189', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '11', 'groupId': 'BG009'}, {'value': '106', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}, {'value': '20', 'groupId': 'BG009'}, {'value': '295', 'groupId': 'BG010'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All subjects that were dispensed a study lens and solution.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2010-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2010-01-22', 'resultsFirstSubmitDate': '2016-08-10', 'studyFirstSubmitQcDate': '2010-01-22', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-28', 'studyFirstPostDateStruct': {'date': '2010-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Slit Lamp Findings (SLF)', 'timeFrame': 'Up to 3 months Post Lens Wear', 'description': 'Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.'}, {'measure': 'Distance Visual Acuity (LogMAR)', 'timeFrame': 'Up to 3 Months Post Lens Wear', 'description': 'Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Contact Lens Wear']}, 'descriptionModule': {'briefSummary': 'This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must be an adapted contact lens wearer\n* best corrected distance visual acuity must be 20/25 or better in each eye\n* must be wearing their habitual lenses on a daily wear basis\n* must be willing to refrain from swimming during the study\n\nExclusion Criteria:\n\n* any systemic diseases that may interfere with contact lens wear\n* any clinically significant ocular disease\n* any ocular infection\n* use of certain medications\n* any grade 2 or greater slit lamp findings\n* any know sensitivity to marketed contact lens care solutions\n* currently pregnant or lactating\n* monovision corrected'}, 'identificationModule': {'nctId': 'NCT01055457', 'briefTitle': 'Vistakon Investigational Multi-purpose Contact Lens Care Solution.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Vision Care, Inc.'}, 'orgStudyIdInfo': {'id': 'CR-1650'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Multi-Purpose Solution', 'description': 'contact lens care solution', 'interventionNames': ['Device: Vistakon Investigational Multi-Purpose Solution II']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ReNu MultiPlus Multi-Purpose Solution', 'description': 'contact lens care solution', 'interventionNames': ['Device: ReNu MultiPlus Multi-Purpose Solution']}], 'interventions': [{'name': 'Vistakon Investigational Multi-Purpose Solution II', 'type': 'DEVICE', 'description': 'contact lens care solution', 'armGroupLabels': ['Experimental Multi-Purpose Solution']}, {'name': 'ReNu MultiPlus Multi-Purpose Solution', 'type': 'DEVICE', 'description': 'contact lens care solution', 'armGroupLabels': ['ReNu MultiPlus Multi-Purpose Solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'city': 'Jamestown', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.097, 'lon': -79.23533}}, {'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'city': 'Athens', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.32924, 'lon': -82.10126}}, {'city': 'Moon Township', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.50896, 'lon': -80.23923}}, {'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'city': 'Katy', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Vision Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}