Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-31 @ 1:39 PM
Study NCT ID:
NCT01240135
Status:
COMPLETED
Last Update Posted:
2012-07-12
First Post:
2010-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A
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': 'medinfo@alconlabs.com', 'phone': '1-888-451-3937', 'title': 'Director of Alcon Clinical', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Alcon reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study: 11 October 2010 through 2 February 2011.', 'description': 'All subjects who used study treatment or potentially used study treatment were evaluated for safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'FID 114576A', 'description': 'FID 114675A used for contact lens care per protocol-specified instructions for 14 days.', 'otherNumAtRisk': 89, 'otherNumAffected': 0, 'seriousNumAtRisk': 89, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Renu Fresh', 'description': 'Renu fresh used for contact lens care per protocol-specified instructions for 14 days.', 'otherNumAtRisk': 89, 'otherNumAffected': 0, 'seriousNumAtRisk': 89, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lens Fit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 114576A', 'description': 'FID 114675A used for contact lens care per protocol-specified instructions for 14 days.'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Renu fresh used for contact lens care per protocol-specified instructions for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14 of lens wear', 'description': 'As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.', 'unitOfMeasure': 'percentage of acceptable fit', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 114576A', 'description': 'FID 114675A used for contact lens care per protocol-specified instructions for 14 days.'}, {'id': 'OG001', 'title': 'Renu Fresh', 'description': 'Renu fresh used for contact lens care per protocol-specified instructions for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '2.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 of lens wear', 'description': 'The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: All randomized subjects with at least one post-baseline assessment after dispensing, according to randomized treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FID 114576A / Renu Fresh', 'description': 'FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.'}, {'id': 'FG001', 'title': 'Renu Fresh / FID 114675A', 'description': 'Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.'}], 'periods': [{'title': 'Period One, 14 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period Two, 14 Days of Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited from 5 US study centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FID 114576A / Renu Fresh', 'description': 'FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.'}, {'id': 'BG001', 'title': 'Renu Fresh / FID 114675A', 'description': 'Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'spread': '11.44', 'groupId': 'BG000'}, {'value': '31.4', 'spread': '9.71', 'groupId': 'BG001'}, {'value': '32.8', 'spread': '10.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-08', 'studyFirstSubmitDate': '2010-11-10', 'resultsFirstSubmitDate': '2012-06-08', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-08', 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Fit', 'timeFrame': 'Day 14 of lens wear', 'description': 'As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score', 'timeFrame': 'Day 14 of lens wear', 'description': 'The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contact Lens Wear', 'Contact Lens Solution', 'Multi-purpose disinfecting solution', 'Myopia'], 'conditions': ['Contact Lens Fit', 'Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older.\n* History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.\n* Wear contact lenses a minimum of 8 hours per day prior to Visit 1.\n* Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.\n* Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.\n* History of intolerance or known sensitivity to any component of the treatments.\n* Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01240135', 'briefTitle': 'Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A', 'orgStudyIdInfo': {'id': 'C-10-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FID 114576A / renu fresh', 'description': 'FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.', 'interventionNames': ['Device: FID 114675A multi-purpose disinfecting solution (MPDS)', 'Device: renu fresh Multi-Purpose Solution (MPS)', 'Device: Galyfilcon A contact lenses (Acuvue Advance)']}, {'type': 'OTHER', 'label': 'renu fresh / FID 114675A', 'description': 'Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.', 'interventionNames': ['Device: FID 114675A multi-purpose disinfecting solution (MPDS)', 'Device: renu fresh Multi-Purpose Solution (MPS)', 'Device: Galyfilcon A contact lenses (Acuvue Advance)']}], 'interventions': [{'name': 'FID 114675A multi-purpose disinfecting solution (MPDS)', 'type': 'DEVICE', 'otherNames': ['Alcon Multi-Purpose Disinfecting Solution (MPDS)'], 'description': 'Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.', 'armGroupLabels': ['FID 114576A / renu fresh', 'renu fresh / FID 114675A']}, {'name': 'renu fresh Multi-Purpose Solution (MPS)', 'type': 'DEVICE', 'otherNames': ['Bausch + Lomb renu® fresh™ Multi-Purpose Solution'], 'description': 'Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.', 'armGroupLabels': ['FID 114576A / renu fresh', 'renu fresh / FID 114675A']}, {'name': 'Galyfilcon A contact lenses (Acuvue Advance)', 'type': 'DEVICE', 'otherNames': ['Acuvue® Advance®'], 'description': "A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.", 'armGroupLabels': ['FID 114576A / renu fresh', 'renu fresh / FID 114675A']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}