Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT00724269
Status:
COMPLETED
Last Update Posted:
2012-10-01
First Post:
2008-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of OPTI-FREE RepleniSH and ReNu Multi-Plus Lens Care Regimens on Corneal Epithelium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-28', 'studyFirstSubmitDate': '2008-07-25', 'studyFirstSubmitQcDate': '2008-07-28', 'lastUpdatePostDateStruct': {'date': '2012-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confocal microscopy analysis of Corneal Epithelium', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Patient comfort', 'timeFrame': '2 weeks'}, {'measure': 'Corneal Staining', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contact lens wear', 'multi-purpose solution', 'corneal staining'], 'conditions': ['Contact Lens Wear']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the corneal epithelium after soft contact lens wear and use of two marketed multi-purpose solutions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Successful contact lens wear on a daily wear basis\n* Wear contact lenses at least 8 hours/day\n* Vision correctable to at least 20/30\n* Normal Eyes\n* Other protocol-defined inclusion criteria may apply\n\nExclusion:\n\n* Topical ocular medication use\n* Other protocol-defined inclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00724269', 'briefTitle': 'Comparison of OPTI-FREE RepleniSH and ReNu Multi-Plus Lens Care Regimens on Corneal Epithelium', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'SMA-08-04 / BP-08-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Opti Free RepliniSH', 'description': 'Opti Free RepliniSH', 'interventionNames': ['Device: OPTI-FREE RepleniSH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ReNu Multi-Plus', 'description': 'ReNu Multi-Plus', 'interventionNames': ['Device: ReNu MultiPlus MPS']}], 'interventions': [{'name': 'OPTI-FREE RepleniSH', 'type': 'DEVICE', 'description': 'Multi-Purpose Solution for soft contact lenses', 'armGroupLabels': ['Opti Free RepliniSH']}, {'name': 'ReNu MultiPlus MPS', 'type': 'DEVICE', 'description': 'Multi-Purpose Solution for soft contact lenses', 'armGroupLabels': ['ReNu Multi-Plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center for Study Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}