Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-02 @ 9:12 PM
Study NCT ID:
NCT00885092
Status:
COMPLETED
Last Update Posted:
2012-03-27
First Post:
2009-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '1-888-451-3937', 'title': 'Director of Alcon Clinical', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the duration of the study: 24 March 2009 to 5 May 2009.', 'description': 'This reporting group includes all participants enrolled and exposed to test regimen.', 'eventGroups': [{'id': 'EG000', 'title': 'FID 114675A', 'description': 'FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'RepleniSH', 'description': 'Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Ex-Vivo Wetting Angle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 114675A', 'description': 'FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.'}, {'id': 'OG001', 'title': 'RepleniSH', 'description': 'Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.1', 'spread': '32.7', 'groupId': 'OG000'}, {'value': '59.6', 'spread': '38.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, Hour 14', 'description': 'Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.', 'unitOfMeasure': 'Degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.'}, {'type': 'SECONDARY', 'title': 'Mean Lens Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 114675A', 'description': 'FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.'}, {'id': 'OG001', 'title': 'RepleniSH', 'description': 'Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7, Hour 14', 'description': 'Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, "My lenses feel comfortable right now," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Solution-Related Corneal Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FID 114675A', 'description': 'FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.'}, {'id': 'OG001', 'title': 'RepleniSH', 'description': 'Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7, Hour 14', 'description': 'Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes and is reported as a percentage of total participants.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat: All participants who received regimen and had at least one on-therapy visit. Cross-over study design.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FID 114675A / RepleniSH', 'description': 'FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.'}, {'id': 'FG001', 'title': 'RepleniSH / FID 114675A', 'description': 'RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.'}], 'periods': [{'title': 'Period 1, 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2, 7 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from one US study center.', 'preAssignmentDetails': '40 participants with normal eyes (other than vision correction) were enrolled in the trial. After the screening visit, participants discontinued contact lens wear and wore their glasses for at least 2 days as a washout prior to Period 1. A similar washout occurred prior to Period 2. Cross-over study design.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FID 114675A / RepleniSH', 'description': 'FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.'}, {'id': 'BG001', 'title': 'RepleniSH / FID 114675A', 'description': 'RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '42.4', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '42.6', 'spread': '10.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-21', 'studyFirstSubmitDate': '2009-04-17', 'resultsFirstSubmitDate': '2012-02-24', 'studyFirstSubmitQcDate': '2009-04-20', 'lastUpdatePostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-02-24', 'studyFirstPostDateStruct': {'date': '2009-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Ex-Vivo Wetting Angle', 'timeFrame': 'Day 7, Hour 14', 'description': 'Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.'}], 'secondaryOutcomes': [{'measure': 'Mean Lens Comfort', 'timeFrame': 'Day 7, Hour 14', 'description': 'Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, "My lenses feel comfortable right now," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.'}, {'measure': 'Percentage of Participants With Solution-Related Corneal Staining', 'timeFrame': 'Day 7, Hour 14', 'description': 'Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes and is reported as a percentage of total participants.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contact lenses', 'Disinfecting solutions'], 'conditions': ['Contact Lens Care']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to clinically evaluate an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older.\n* Must be successfully wearing assigned study lens brand (either ACUVUE® OASYS™ or PureVision® contact lenses) for at least 7-10 days, minimum 8 hours a day, prior to Visit 1 (screening).\n* Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1 (screening).\n* Must have discontinued contact lens wear for at least two consecutive days before Visit 2 (baseline).\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.\n* Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).\n* Monocular vision (only one eye with functional vision) or fit with only one contact lens.\n* Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.\n* Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.\n* Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months.\n* Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits.\n* Corneal staining area assessment ≥ 20% in any corneal region in either eye at screening or baseline visit.\n* Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit.\n* Participation in any investigational clinical study within 30 days of baseline visit.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00885092', 'briefTitle': 'Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Wettability of Silicone Hydrogel Lenses With SiH MPDS FID 114675A vs. A Marketed Multi-Purpose Solution', 'orgStudyIdInfo': {'id': 'C-08-082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'FID 114675A / RepleniSH', 'description': 'FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.', 'interventionNames': ['Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)', 'Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)', 'Device: Senofilcon A contact lens (ACUVUE® Oasys™)', 'Device: Balafilcon A contact lens (PureVision®)']}, {'type': 'OTHER', 'label': 'RepleniSH / FID 114675A', 'description': 'RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.', 'interventionNames': ['Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)', 'Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)', 'Device: Senofilcon A contact lens (ACUVUE® Oasys™)', 'Device: Balafilcon A contact lens (PureVision®)']}], 'interventions': [{'name': 'FID 114675A Multi-Purpose Disinfecting Solution (MPDS)', 'type': 'DEVICE', 'description': 'Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.', 'armGroupLabels': ['FID 114675A / RepleniSH', 'RepleniSH / FID 114675A']}, {'name': 'RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)', 'type': 'DEVICE', 'otherNames': ['(OPTI-FREE® RepleniSH®)'], 'description': 'Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.', 'armGroupLabels': ['FID 114675A / RepleniSH', 'RepleniSH / FID 114675A']}, {'name': 'Senofilcon A contact lens (ACUVUE® Oasys™)', 'type': 'DEVICE', 'otherNames': ['ACUVUE® Oasys™'], 'description': 'Commercially marketed silicone hydrogel contact lens for daily wear use', 'armGroupLabels': ['FID 114675A / RepleniSH', 'RepleniSH / FID 114675A']}, {'name': 'Balafilcon A contact lens (PureVision®)', 'type': 'DEVICE', 'otherNames': ['PureVision®'], 'description': 'Commercially marketed silicone hydrogel contact lens for daily wear use', 'armGroupLabels': ['FID 114675A / RepleniSH', 'RepleniSH / FID 114675A']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}