Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
Study NCT ID:
NCT00691457
Status:
COMPLETED
Last Update Posted:
2012-10-01
First Post:
2008-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-28', 'studyFirstSubmitDate': '2008-06-03', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2012-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in corneal fluorescein staining as evaluated at Day 30', 'timeFrame': '30 Days'}], 'secondaryOutcomes': [{'measure': 'Confocal evaluation variables as measured at Days 0, 14, and 30', 'timeFrame': 'Day 0, 14, 30'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contact lens', 'solution', 'confocal microscope'], 'conditions': ['Contact Lens Solution']}, 'descriptionModule': {'briefSummary': 'Three arm study comparing three novel contact lens solutions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Stable distance contact lens prescription between -0.50 D and 9.00 D and astigmatism less than or equal to -1.00 D cylindrical (cyl).\n* Stable correction is defined as longer than six months.\n* Worn a single brand of disposable silicone hydrogel contact lenses successfully (i.e., without complications or discomfort) for a minimum of six months\n\nExclusion:\n\n* Known sensitivity to the contact lens disinfecting solutions or fluorescein dye.\n* Any systemic or ocular disease that could affect contact lens wear.\n* Women who are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT00691457', 'briefTitle': 'Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina', 'orgStudyIdInfo': {'id': 'SMA-08-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Opti-Free contact lens solution', 'interventionNames': ['Device: Opti-Free contact lens solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'ReNu Multiplus contact lens solution', 'interventionNames': ['Device: ReNu Multiplus contact lens solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Clear Care contact lens solution', 'interventionNames': ['Device: Clear Care contact lens solution']}], 'interventions': [{'name': 'Opti-Free contact lens solution', 'type': 'DEVICE', 'description': 'Solution', 'armGroupLabels': ['1']}, {'name': 'ReNu Multiplus contact lens solution', 'type': 'DEVICE', 'description': 'Solution', 'armGroupLabels': ['2']}, {'name': 'Clear Care contact lens solution', 'type': 'DEVICE', 'description': 'Solution', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23462', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Beach, VA', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}