Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT00520351
Status:
COMPLETED
Last Update Posted:
2010-09-16
First Post:
2007-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cawoods@sciborg.uwaterloo.ca', 'phone': '519-888-4567', 'title': 'Craig A Woods, Research Manager', 'phoneExt': '36547', 'organization': 'Centre for Contact Lens Research'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'An adverse event included any undesirable clinical occurrence in a participant, whether it was considered to be device-related or not.', 'eventGroups': [{'id': 'EG000', 'title': 'ClearCare First, Then Optifree Replenish', 'description': 'In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Optifree Replenish First, Then ClearCare', 'description': 'In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'High Contrast Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ClearCare First, Then Optifree Replenish', 'description': 'In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.'}, {'id': 'OG001', 'title': 'Optifree Replenish First, Then ClearCare', 'description': 'In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': "High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.\n\n10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.", 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Low Contrast Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ClearCare First, Then Optifree Replenish', 'description': 'In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.'}, {'id': 'OG001', 'title': 'Optifree Replenish First, Then ClearCare', 'description': 'In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': "Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.\n\n10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step.", 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per protocol'}, {'type': 'PRIMARY', 'title': 'In-vivo Wettability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ClearCare First, Then Optifree Replenish', 'description': 'In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.'}, {'id': 'OG001', 'title': 'Optifree Replenish First, Then ClearCare', 'description': 'In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.06', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '8.3'}, {'value': '6.54', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '7.4'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '2 weeks', 'description': 'Pre-lens non-invasive tear breakup time', 'unitOfMeasure': 'Seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subjective Comfort Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ClearCare First, Then Optifree Replenish', 'description': 'In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.'}, {'id': 'OG001', 'title': 'Optifree Replenish First, Then ClearCare', 'description': 'In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.5', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '94.8'}, {'value': '81.3', 'groupId': 'OG001', 'lowerLimit': '64.9', 'upperLimit': '97.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks', 'description': 'Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ClearCare First, Then Optifree Replenish', 'description': 'In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.'}, {'id': 'FG001', 'title': 'Optifree Replenish First, Then ClearCare', 'description': 'In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Start date is Sep.06, 2007', 'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'Start date is Sep.06, 2007', 'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'End date is Feb.25, 2008', 'groupId': 'FG000', 'numSubjects': '14'}, {'comment': 'End date is Feb.25, 2008', 'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study completion date is August 2008', 'preAssignmentDetails': 'Washout for 2 to 3 days following screening (wear spectacles only).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ClearCare First, Then Optifree Replenish', 'description': 'In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.'}, {'id': 'BG001', 'title': 'Optifree Replenish First, Then ClearCare', 'description': 'In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.'}, {'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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', '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': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '24.1', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '24.3', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-20', 'studyFirstSubmitDate': '2007-08-21', 'resultsFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2007-08-23', 'lastUpdatePostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-08-20', 'studyFirstPostDateStruct': {'date': '2007-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High Contrast Visual Acuity', 'timeFrame': '2 weeks', 'description': "High Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.\n\n10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step."}, {'measure': 'Low Contrast Visual Acuity', 'timeFrame': '2 weeks', 'description': "Low Contrast Visual Acuity with contact lenses, was measured using standardized and computer generated logMAR chart.\n\n10 Sloan letters adopted. VA chart's target size varied from logMAR 1.0 to -0.40 in 0.1 logMAR step."}, {'measure': 'In-vivo Wettability', 'timeFrame': '2 weeks', 'description': 'Pre-lens non-invasive tear breakup time'}, {'measure': 'Subjective Comfort Rating', 'timeFrame': '2 weeks', 'description': 'Numeric rating scale was administered. Comfort ratings (0 - 100), 0 = Very poor comfort and 100 = Excellent comfort.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.', 'detailedDescription': 'The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms by observing changes within the cornea and collecting subjective ratings'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA person is eligible for inclusion in the study if he/she:\n\n1. Is at least 17 years of age and has full legal capacity to volunteer.\n2. Has read, understood and signed an information consent letter.\n3. Is willing and able to follow instructions and maintain the appointment schedule.\n4. Is presently using either bi-weekly or monthly replacement lenses.\n5. Has symptoms of ocular dryness as determined by specific pre-screening criteria.\n6. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.\n7. Has clear corneas and no active ocular disease.\n8. Has had an ocular examination in the last two years.\n\nExclusion Criteria:\n\nA person will be excluded from the study if he/she:\n\n1. Is an asymptomatic lens wearer.\n2. Is a daily disposable contact lens wearer.\n3. Is a current extended wear contact lens wearer.\n4. Currently uses one of the study lens care regimens.\n5. Has any clinically significant blepharitis.\n6. Has undergone corneal refractive surgery.\n7. Is aphakic.\n8. Has any active ocular disease.\n9. Has any systemic disease affecting ocular health.\n10. Is using any systemic or topical medications that may affect ocular health.\n11. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.\n12. Is participating in any other type of clinical or research study.'}, 'identificationModule': {'nctId': 'NCT00520351', 'briefTitle': 'Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)', 'organization': {'class': 'OTHER', 'fullName': 'University of Waterloo'}, 'officialTitle': 'Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)', 'orgStudyIdInfo': {'id': 'P/265/07/L'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: ClearCare']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Optifree Replenish']}], 'interventions': [{'name': 'ClearCare', 'type': 'DRUG', 'description': 'contact lens care system', 'armGroupLabels': ['1']}, {'name': 'Optifree Replenish', 'type': 'DRUG', 'description': 'contact lens care system', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Contact Lens Research, School of Optometry, University of Waterloo.', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Desmond Fonn, M. Optom', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Waterloo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Waterloo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Craig Woods, Research Manager', 'oldOrganization': 'CCLR'}}}}