Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT00961051
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2009-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of an Investigational Multi-Purpose Solution (MPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eugenia.thomas@amo.abbott.com', 'phone': '714-247-8723', 'title': 'Eugenia Thomas, O.D.', 'organization': 'Abbott Medical Optics'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to publication release and can embargo communications regarding trials results for a period that is more than 90 days but less than or equal to 18 months from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Investigational MPS', 'description': 'Investigational multipurpose disinfecting solution (study MPS)', 'otherNumAtRisk': 177, 'otherNumAffected': 6, 'seriousNumAtRisk': 177, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Predicate MPS', 'description': 'Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)', 'otherNumAtRisk': 93, 'otherNumAffected': 12, 'seriousNumAtRisk': 93, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Red eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal infiltrates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign body sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seasonal eye allergies', 'notes': 'Seasonal eye allergies may also cause dry eyes, redness, blurry vision, and light sensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial punctate keratopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Giant papillary conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Recurrent corneal erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersensitivity to study solution', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 177, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Lens Cleanliness as Measured by Light Reflectance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational MPS', 'description': 'Investigational multipurpose disinfecting solution (study MPS)'}, {'id': 'OG001', 'title': 'Predicate MPS', 'description': 'Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)'}], 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'spread': '13.92', 'groupId': 'OG000'}, {'value': '66.8', 'spread': '14.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 30', 'description': 'Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).', 'unitOfMeasure': 'light reflectance score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Lens cleanliness analysis could only be done on subjects whose lenses were returned for analysis. Out of 270 subjects, 253 returned their study lenses to the sponsor for lab analysis (169 + 84 = 253).'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With no Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational MPS', 'description': 'Investigational multipurpose disinfecting solution (study MPS)'}, {'id': 'OG001', 'title': 'Predicate MPS', 'description': 'Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)'}], 'classes': [{'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 180', 'description': 'Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Investigational MPS', 'description': 'Investigational multipurpose disinfecting solution (study MPS)'}, {'id': 'FG001', 'title': 'Predicate MPS', 'description': 'Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}], 'recruitmentDetails': 'Subjects for this study were chosen from the normal hydrogel contact lens-wearing patient populations at each of the investigational sites according to the following inclusion and exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Investigational MPS', 'description': 'Investigational multipurpose disinfecting solution (study MPS)'}, {'id': 'BG001', 'title': 'Predicate MPS', 'description': 'Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 270}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-06', 'studyFirstSubmitDate': '2009-07-27', 'resultsFirstSubmitDate': '2013-05-16', 'studyFirstSubmitQcDate': '2009-08-17', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-06', 'studyFirstPostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Lens Cleanliness as Measured by Light Reflectance', 'timeFrame': 'Day 30', 'description': 'Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With no Corneal Staining', 'timeFrame': 'Day 180', 'description': 'Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adapted contact lens wearers'], 'conditions': ['Study Focus is Healthy Contact Lens Wearers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.', 'detailedDescription': 'A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have successfully worn hydrogel contact lenses of the same material to be worn during the study\n* Have normal eyes (with the exception of unaided visual acuity)\n* Have successfully used a multi-purpose contact lens care solution\n* Have acceptable visual acuity and lens wearing comfort at time of enrollment\n\nExclusion Criteria:\n\n* Concurrently enrolled another clinical trial\n* Have a known sensitivity to any study product ingredient(s)\n* Have a condition that may put them at significant risk'}, 'identificationModule': {'nctId': 'NCT00961051', 'briefTitle': 'Evaluation of an Investigational Multi-Purpose Solution (MPS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Optics'}, 'officialTitle': 'Evaluation of an Investigational MPS', 'orgStudyIdInfo': {'id': 'COBR-105-9608'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational MPS', 'description': 'Investigational multipurpose disinfecting solution (study MPS)', 'interventionNames': ['Device: Investigational MPS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Predicate MPS', 'description': 'Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)', 'interventionNames': ['Device: Opti-Free']}], 'interventions': [{'name': 'Investigational MPS', 'type': 'DEVICE', 'otherNames': ['Cobra'], 'description': 'Multi-purpose solution', 'armGroupLabels': ['Investigational MPS']}, {'name': 'Opti-Free', 'type': 'DEVICE', 'otherNames': ['RepleniSH'], 'description': 'Multi-purpose solution', 'armGroupLabels': ['Predicate MPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Complete Family Vision Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '96797', 'city': 'Waipahu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Eye Care Associates of Hawaii', 'geoPoint': {'lat': 21.38667, 'lon': -158.00917}}, {'zip': '64093', 'city': 'Warrensburg', 'state': 'Missouri', 'country': 'United States', 'facility': 'Insight Eyecare', 'geoPoint': {'lat': 38.76279, 'lon': -93.73605}}, {'zip': '45701', 'city': 'Athens', 'state': 'Ohio', 'country': 'United States', 'facility': 'Drs. Quinn, Quinn & Associates', 'geoPoint': {'lat': 39.32924, 'lon': -82.10126}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Western Reserve Vision Care', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '43202', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Central Ohio Eyecare', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '18503', 'city': 'Scranton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Northeastern Eye Institute', 'geoPoint': {'lat': 41.40916, 'lon': -75.6649}}, {'zip': '02888', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'West Bay Eye Associates', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '53227', 'city': 'West Allis', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Ziegler Leffingwell Eyecare', 'geoPoint': {'lat': 43.01668, 'lon': -88.00703}}], 'overallOfficials': [{'name': 'Nicholas Tarantino, OD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Medical Optics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Optics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}