Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-29 @ 9:46 AM
Study NCT ID:
NCT01335750
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2010-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand
Sponsor:
Organization:
Raw JSON
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Visit 2: 2 hours, Visit 3: 4 hours', 'description': 'Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)'}, {'type': 'SECONDARY', 'title': 'Subjective Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Multipurpose Solution #1', 'description': 'B\\&L Renu Fresh Multipurpose Solution'}, {'id': 'OG001', 'title': 'Multipurpose Solution #2', 'description': 'Optifree Replenish Multipurpose Solution'}, {'id': 'OG002', 'title': 'Multipurpose Solution #3', 'description': 'Ciba ClearCare Multipurpose Solution'}, {'id': 'OG003', 'title': 'Multipurpose Solution #4', 'description': 'Saline Solution'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '84.9', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '81.1', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '85.0', 'spread': '14.4', 'groupId': 'OG002'}, {'value': '85.1', 'spread': '13.1', 'groupId': 'OG003'}]}]}, {'title': '2 Hour Period', 'categories': [{'measurements': [{'value': '82.8', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '76.9', 'spread': '19.4', 'groupId': 'OG001'}, {'value': '83.0', 'spread': '15.3', 'groupId': 'OG002'}, {'value': '81.7', 'spread': '16.6', 'groupId': 'OG003'}]}]}, {'title': '4 Hour Period', 'categories': [{'measurements': [{'value': '81.4', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '76.2', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '81.9', 'spread': '16.8', 'groupId': 'OG002'}, {'value': '83.1', 'spread': '17.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours', 'description': 'Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)'}, {'type': 'PRIMARY', 'title': 'Corneal Staining Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Mutlipurpose Solution #1', 'description': 'Optifree Replenish Multipurpose Solution'}, {'id': 'OG001', 'title': 'Multipurpose Solution #2', 'description': 'B\\&L Renu Fresh Multipurpose Solution'}, {'id': 'OG002', 'title': 'Multipurpose Solution #3', 'description': 'Ciba ClearCare Multipurpose Solution'}, {'id': 'OG003', 'title': 'Multipurpose Solution #4', 'description': 'Saline solution'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.01', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': '2 Hour Period', 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.76', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.06', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': '3 Hour Period', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.59', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.06', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 Hour Period, 4 Hour Period', 'description': "Severity of staining was recorded for each region using a scale of 0-none to 4-patch \\>/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Severity of staining was recorded for each region using a scale of 0-none to 4-patch \\>/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit."}, {'type': 'PRIMARY', 'title': 'Corneal Staining Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Multipurpose Solution #1', 'description': 'Optifree Replenish'}, {'id': 'OG001', 'title': 'Multipurpose Solution #2', 'description': 'B\\&L Renu Fresh Multipurpose Solution'}, {'id': 'OG002', 'title': 'Multipurpose Solution #3', 'description': 'Ciba ClearCare Multipurpose Solution'}, {'id': 'OG003', 'title': 'Multipurpose Solution #4', 'description': 'Saline Solution'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0', 'groupId': 'OG003'}]}]}, {'title': '2 Hour Period', 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '1.3', 'groupId': 'OG003'}]}]}, {'title': '3 Hour Period', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.4', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '1.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 Hour Period, 4 Hour Period', 'description': "Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Multipurpose Solution', 'description': 'To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Multipurpose Solution', 'description': 'To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '62'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-17', 'studyFirstSubmitDate': '2010-10-07', 'resultsFirstSubmitDate': '2012-04-30', 'studyFirstSubmitQcDate': '2011-04-13', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-03-04', 'studyFirstPostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal Staining Severity', 'timeFrame': 'Baseline, 2 Hour Period, 4 Hour Period', 'description': "Severity of staining was recorded for each region using a scale of 0-none to 4-patch \\>/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit."}, {'measure': 'Corneal Staining Area', 'timeFrame': 'Baseline, 2 Hour Period, 4 Hour Period', 'description': "Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit."}], 'secondaryOutcomes': [{'measure': 'Subjective Comfort', 'timeFrame': 'Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours', 'description': 'Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)'}, {'measure': 'Subjective Dryness', 'timeFrame': 'Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours', 'description': 'Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['corneal staining'], 'conditions': ['Corneal Staining']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.StainingGrid.com', 'label': 'Click here for more information about similar studies'}]}, 'descriptionModule': {'briefSummary': 'This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent and HIPAA document read, signed, and dated.\n* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.\n* Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.\n\nExclusion Criteria:\n\n* History of hypersensitivity\n* Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye\n* One functional eye or a monofit eye\n* Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis\n* Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period\n* Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period\n* Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period\n* Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period\n* Abnormal lenticular opacity in the visual axis of the lens in either eye\n* Use of concomitant topical Rx or over-the-counter (OTC) ocular medications\n* History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear\n* Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT01335750', 'briefTitle': 'A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand', 'orgStudyIdInfo': {'id': 'CV-09-64, Sterling IRB 3576'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multipurpose Solution #1', 'description': 'B\\&L Renu Fresh Multipurpose Solution', 'interventionNames': ['Other: Multipurpose Solution #1', 'Other: Multipurpose Solution #2', 'Other: Mutlipurpose Solution #3', 'Other: Multipurpose Solution #4']}, {'type': 'EXPERIMENTAL', 'label': 'Multipurpose Solution #2', 'description': 'OptiFree Replenish Multipurpose Solution', 'interventionNames': ['Other: Multipurpose Solution #1', 'Other: Multipurpose Solution #2', 'Other: Mutlipurpose Solution #3', 'Other: Multipurpose Solution #4']}, {'type': 'EXPERIMENTAL', 'label': 'Multipurpose Solution #3', 'description': 'Ciba ClearCare Multipurpose Solution', 'interventionNames': ['Other: Multipurpose Solution #1', 'Other: Multipurpose Solution #2', 'Other: Mutlipurpose Solution #3', 'Other: Multipurpose Solution #4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multipurpose Solution #4', 'description': 'Saline Solution', 'interventionNames': ['Other: Multipurpose Solution #1', 'Other: Multipurpose Solution #2', 'Other: Mutlipurpose Solution #3', 'Other: Multipurpose Solution #4']}], 'interventions': [{'name': 'Multipurpose Solution #1', 'type': 'OTHER', 'description': 'B\\&L Renu Fresh Multipurpose Solution', 'armGroupLabels': ['Multipurpose Solution #1', 'Multipurpose Solution #2', 'Multipurpose Solution #3', 'Multipurpose Solution #4']}, {'name': 'Multipurpose Solution #2', 'type': 'OTHER', 'description': 'Optifree Replenish Multipurpose Solution', 'armGroupLabels': ['Multipurpose Solution #1', 'Multipurpose Solution #2', 'Multipurpose Solution #3', 'Multipurpose Solution #4']}, {'name': 'Mutlipurpose Solution #3', 'type': 'OTHER', 'description': 'Ciba ClearCare Multipurpose Solution', 'armGroupLabels': ['Multipurpose Solution #1', 'Multipurpose Solution #2', 'Multipurpose Solution #3', 'Multipurpose Solution #4']}, {'name': 'Multipurpose Solution #4', 'type': 'OTHER', 'description': 'Saline Solution', 'armGroupLabels': ['Multipurpose Solution #1', 'Multipurpose Solution #2', 'Multipurpose Solution #3', 'Multipurpose Solution #4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Erdey/Searcy Eye Group', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Gary Andrasko, OD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erdey/Searcy Eye Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}