Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-29 @ 6:35 AM
Study NCT ID:
NCT03897751
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Johnson.Varughese@bauschhealth.com', 'phone': '9089271162', 'title': 'Johnson Varughese', 'organization': 'Bausch & Lomb'}, 'certainAgreement': {'otherDetails': 'Please contact sponsor for details.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'ABT12 Multi-Purpose Solution', 'description': 'Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nABT12 Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 0, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'COMPLETE Multi-Purpose Solution', 'description': 'Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nCOMPLETE Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 0, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT12 Multi-Purpose Solution', 'description': 'Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nABT12 Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}, {'id': 'OG001', 'title': 'COMPLETE Multi-Purpose Solution', 'description': 'Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nCOMPLETE Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'spread': '11.49', 'groupId': 'OG000'}, {'value': '87.5', 'spread': '12.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Randomized participants who attended the 3-month visit and did not have major protocol deviations'}, {'type': 'PRIMARY', 'title': 'Eye Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT12 Multi-Purpose Solution', 'description': 'Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nABT12 Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}, {'id': 'OG001', 'title': 'COMPLETE Multi-Purpose Solution', 'description': 'Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nCOMPLETE Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.2', 'spread': '15.15', 'groupId': 'OG000'}, {'value': '83.1', 'spread': '14.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Randomized participants who attended the 3-month visit and did not have major protocol deviations'}, {'type': 'PRIMARY', 'title': 'Degree Of Lens Deposits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT12 Multi-Purpose Solution', 'description': 'Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nABT12 Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}, {'id': 'OG001', 'title': 'COMPLETE Multi-Purpose Solution', 'description': 'Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nCOMPLETE Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}], 'classes': [{'categories': [{'title': 'None or Light', 'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}, {'title': 'Medium or Heavy', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Month 3', 'description': 'Degree of lens deposits will be assessed for each eye as none, light, medium, or heavy.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Randomized participants who attended the 3-month visit and did not have major protocol deviations'}, {'type': 'PRIMARY', 'title': 'Proportion Of Participants With Eyes With Grade >2 Slit Lamp Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT12 Multi-Purpose Solution', 'description': 'Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nABT12 Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}, {'id': 'OG001', 'title': 'COMPLETE Multi-Purpose Solution', 'description': 'Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nCOMPLETE Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 (post-dispensing) through Month 3', 'description': 'Graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Greater than Grade 2 findings (Absent, Present) will be summarized at the eye level by treatment.\n\nGrades are 0(none), 1 (Trace), 2 (Mild), 3 (moderate), 4 (severe)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABT12 Multi-Purpose Solution', 'description': 'Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nABT12 Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}, {'id': 'FG001', 'title': 'COMPLETE Multi-Purpose Solution', 'description': 'Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nCOMPLETE Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ABT12 Multi-Purpose Solution', 'description': 'Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nABT12 Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}, {'id': 'BG001', 'title': 'COMPLETE Multi-Purpose Solution', 'description': 'Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.\n\nCOMPLETE Multi-Purpose Solution: Contact lens cleaning and disinfecting solution\n\nSensitive Eyes® Rewetting Drops: For use as needed during the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.4', 'spread': '9.72', 'groupId': 'BG000'}, {'value': '34.1', 'spread': '9.79', 'groupId': 'BG001'}, {'value': '34.3', 'spread': '9.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-13', 'size': 786585, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-04T11:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'dispFirstSubmitDate': '2020-07-07', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-02', 'studyFirstSubmitDate': '2019-03-29', 'dispFirstSubmitQcDate': '2022-11-08', 'resultsFirstSubmitDate': '2022-05-04', 'studyFirstSubmitQcDate': '2019-03-29', 'dispFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-08', 'studyFirstPostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Comfort', 'timeFrame': 'Month 3', 'description': 'Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.'}, {'measure': 'Eye Dryness', 'timeFrame': 'Month 3', 'description': 'Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response.'}, {'measure': 'Degree Of Lens Deposits', 'timeFrame': 'Month 3', 'description': 'Degree of lens deposits will be assessed for each eye as none, light, medium, or heavy.'}, {'measure': 'Proportion Of Participants With Eyes With Grade >2 Slit Lamp Findings', 'timeFrame': 'Day 0 (post-dispensing) through Month 3', 'description': 'Graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Greater than Grade 2 findings (Absent, Present) will be summarized at the eye level by treatment.\n\nGrades are 0(none), 1 (Trace), 2 (Mild), 3 (moderate), 4 (severe)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Contact Lens Cleaning Solution', 'Disinfectants, Contact Lens', 'Soft Contact Lens'], 'conditions': ['Contact Lens Wear']}, 'referencesModule': {'references': [{'pmid': '40216672', 'type': 'DERIVED', 'citation': 'Schaeffer M, Shahidi A, Mosehauer G, Rah M, Reindel W. Clinical Evaluation of Biotrue Hydration Plus Multipurpose Solution in Daily Use with Planned Replacement Soft Contact Lenses. Ophthalmol Ther. 2025 Jun;14(6):1249-1260. doi: 10.1007/s40123-025-01123-0. Epub 2025 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and effectiveness of ABT12 Multi-Purpose solution (Test) compared to COMPLETE® Multi-Purpose Solution Easy Rub® Formula ("COMPLETE Multi-Purpose Solution") when used by participants who are habitual contact lens wearers.', 'detailedDescription': 'Eligible participants will be enrolled from 1 of 5 lens groups based on their habitual contact lenses. Participants will be randomized on a 1:1 basis within each group per site to receive either ABT12 Multi-Purpose solution or COMPLETE Multi-Purpose Solution. The 5 lens groups will be comprised of habitual wearers of soft lenses based on the following lens material:\n\n* Etaficon A, Acuvue2, Vistakon\n* Balafilcon A, PureVision2, Bausch + Lomb\n* Samfilcon A, Ultra, Bausch + Lomb\n* Lotrafilcon B, Optix Aqua, Alcon\n* Senofilcon C, Vita, Vistakon'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate local privacy regulations\n* Is a habitual wearer (at least 3 months) of one of the following lens types: 1) Etaficon A, Acuvue2, Vistakon; 2) Balafilcon A, PureVision2, Bausch + Lomb; 3) Samfilcon A, Ultra, Bausch + Lomb; 4) Lotrafilcon B, Optix Aqua, Alcon; 5) Senofilcon C, Vita, Vistakon\n* Vision is correctable through spherocylindrical refraction to 32 letters (0.3 logarithm of the minimum angle of resolution \\[logMAR\\]) or better (distance, high contrast) in each eye with soft spherical contact lenses\n* Has clear central corneas and is free of any anterior segment disorders\n* Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses\n* Requires lens correction in both eyes\n* Wears the same manufacturer and brand of lens in both eyes\n* Agrees to wear study lenses on a daily wear basis for approximately 3 months\n* Is willing and able to comply with all treatment and follow-up/study procedures\n\nExclusion Criteria:\n\n* Participants who currently use a hydrogen-peroxide cleaning and disinfecting solution\n* Participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation\n* Females of childbearing potential (those who are not surgically sterilized or postmenopausal), if they are currently pregnant, plan to become pregnant during the study, or are breastfeeding\n* Has worn gas permeable (GP) lenses within the last 30 days.\n* Has worn polymethylmethacrylate (PMMA) lenses within the last 3 months\n* Has any systemic disease currently affecting ocular health or which in the Investigator\'s opinion may have an effect on ocular health during the course of the study\n* Has any ocular disease or is using any ocular medication\n* Is using any systemic or topical medications that will, in the Investigator\'s opinion, affect ocular physiology or lens performance\n* Currently wears monovision, multifocal, or toric contact lenses\n* Has ocular astigmatism of 1.00 diopter (D) or greater in either eye\n* Vision is not correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye with soft spherical contact lenses\n* Has anisometropia (spherical equivalent) of greater than 2.00D\n* Has any Grade 2 or greater finding during the slit lamp examination\n* Has corneal infiltrates, of any grade\n* Participants with any "Present" finding during the slit lamp examination that, in the Investigator\'s judgment, interferes with contact lens wear\n* Has any scar or neovascularization within the central 6 millimeters (mm) of the cornea. Note that participants with minor peripheral corneal scarring (that does not extend into the central area), that, in the Investigator\'s judgment, does not interfere with contact lens wear, are eligible for this study\n* Is aphakic\n* Is amblyopic\n* Has had any corneal surgery (for example, refractive surgery)\n* Is allergic to any component in the study care products\n* Is an employee of any of the study investigative sites or a family member of an employee of the investigative site, including family members living outside of the employee\'s household\n* Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or currently resides with a person with any of these specialties\n* Is an employee of a manufacturer of contact lenses or contact lens care products (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Vistakon, or Johnson \\& Johnson) or currently resides with a person employed by any of these manufacturers'}, 'identificationModule': {'nctId': 'NCT03897751', 'briefTitle': 'A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution', 'orgStudyIdInfo': {'id': '932'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABT12 Multi-Purpose Solution', 'description': 'Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.', 'interventionNames': ['Device: ABT12 Multi-Purpose Solution', 'Device: Sensitive Eyes® Rewetting Drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'COMPLETE Multi-Purpose Solution', 'description': 'Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study.', 'interventionNames': ['Device: COMPLETE Multi-Purpose Solution', 'Device: Sensitive Eyes® Rewetting Drops']}], 'interventions': [{'name': 'ABT12 Multi-Purpose Solution', 'type': 'DEVICE', 'description': 'Contact lens cleaning and disinfecting solution', 'armGroupLabels': ['ABT12 Multi-Purpose Solution']}, {'name': 'COMPLETE Multi-Purpose Solution', 'type': 'DEVICE', 'otherNames': ['COMPLETE® Multi-Purpose Solution Easy Rub® Formula'], 'description': 'Contact lens cleaning and disinfecting solution', 'armGroupLabels': ['COMPLETE Multi-Purpose Solution']}, {'name': 'Sensitive Eyes® Rewetting Drops', 'type': 'DEVICE', 'description': 'For use as needed during the study.', 'armGroupLabels': ['ABT12 Multi-Purpose Solution', 'COMPLETE Multi-Purpose Solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Bausch Site 1', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Bausch Site 2', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94112', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Bausch Site 3', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80246', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Bausch Site 4', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Bausch Site 5', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30035', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Bausch Site 6', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Bausch Site 7', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '66048', 'city': 'Leavenworth', 'state': 'Kansas', 'country': 'United States', 'facility': 'Bausch Site 9', 'geoPoint': {'lat': 39.31111, 'lon': -94.92246}}, {'zip': '66762', 'city': 'Pittsburg', 'state': 'Kansas', 'country': 'United States', 'facility': 'Bausch Site 8', 'geoPoint': {'lat': 37.41088, 'lon': -94.70496}}, {'zip': '04101', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Bausch Site 10', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '48823', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bausch Site 11', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '63144', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Bausch Site 12', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14701', 'city': 'Jamestown', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch Site 13', 'geoPoint': {'lat': 42.097, 'lon': -79.23533}}, {'zip': '13850', 'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'facility': 'Bausch Site 14', 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'zip': '16801', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bausch Site 15', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': '37027', 'city': 'Brentwood', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Bausch Site 17', 'geoPoint': {'lat': 36.03312, 'lon': -86.78278}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Bausch Site 16', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Johnson Varughese', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch & Lomb Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}