Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-28 @ 2:42 AM
Study NCT ID:
NCT00829751
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2009-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-02-23', 'releaseDate': '2016-01-26'}, {'resetDate': '2020-08-20', 'releaseDate': '2020-08-11'}, {'resetDate': '2022-05-19', 'releaseDate': '2022-03-01'}, {'resetDate': '2025-03-28', 'releaseDate': '2025-03-12'}, {'resetDate': '2025-05-29', 'releaseDate': '2025-05-08'}], 'estimatedResultsFirstSubmitDate': '2016-01-26'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-31', 'studyFirstSubmitDate': '2009-01-23', 'studyFirstSubmitQcDate': '2009-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The level/amount of sodium fluorescein dye in the anterior chamber at post wear timepoints', 'timeFrame': 'On day of experiment'}], 'secondaryOutcomes': [{'measure': 'Corneal staining level post lens wear', 'timeFrame': 'On day of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['staining', 'toxicity', 'fluorometry', 'dye diffusion', 'anterior chamber'], 'conditions': ['Contact Lens Solution Toxicity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to more objectively evaluate potential lens-material/care solution bio-incompatibilities. We will do this by measuring corneal staining and the amount of fluorescein dye diffusion into the eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age.\n* Best correctable vision to 20/40 in each eye.\n* Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and fluorometry measurement period.\n* No known ocular or systemic allergies, which may interfere with contact lens wear.\n* No known systemic disease, or need for medication that may interfere with contact les wear (i.e. antihistamines, beta-blockers, steroids, ect.).\n\nExclusion Criteria:\n\n* Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.\n* Eye (ocular) or systemic allergies that may interfere with contact lens wear.\n* Clinically significant corneal swelling (greater than 3 or 4 on a 0-4 scale), corneal blood vessel growth (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.\n* Are taking part in any other study or have taken part in a study within the last 14 days.\n* Are pregnant, or anticipating to become pregnant during the course of the study.'}, 'identificationModule': {'nctId': 'NCT00829751', 'briefTitle': 'The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility', 'organization': {'class': 'OTHER', 'fullName': 'Southern California College of Optometry at Marshall B. Ketchum University'}, 'officialTitle': 'The Physiological Consequence of Silicone-hydrogel Care-solution Bio-incompatibility', 'orgStudyIdInfo': {'id': '08-8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ReNu Multiplus', 'description': 'Purevision lenses will be soaked in ReNu Multiplus', 'interventionNames': ['Device: PureVision lenses soaked in ReNu Multiplus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OptiFree RePlenish', 'description': 'PureVision lenses will be soaked in OptiFree RePlenish', 'interventionNames': ['Device: PureVision lenses soaked in OptiFree RePlenish']}], 'interventions': [{'name': 'PureVision lenses soaked in ReNu Multiplus', 'type': 'DEVICE', 'description': 'Purevision silicone hydrogel lenses', 'armGroupLabels': ['ReNu Multiplus']}, {'name': 'PureVision lenses soaked in OptiFree RePlenish', 'type': 'DEVICE', 'description': 'Purevision silicone hydrogel lenses soaked in OptiFree RePlenish', 'armGroupLabels': ['OptiFree RePlenish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92831', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Southern California College of Optometry', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}], 'overallOfficials': [{'name': 'Jerry R Paugh, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern California College of Optometry at Marshall B. Ketchum University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern California College of Optometry at Marshall B. Ketchum University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Associate Dean for Research', 'investigatorFullName': 'Jerry R. Paugh, OD, PhD', 'investigatorAffiliation': 'Southern California College of Optometry at Marshall B. Ketchum University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-01-26', 'type': 'RELEASE'}, {'date': '2016-02-23', 'type': 'RESET'}, {'date': '2020-08-11', 'type': 'RELEASE'}, {'date': '2020-08-20', 'type': 'RESET'}, {'date': '2022-03-01', 'type': 'RELEASE'}, {'date': '2022-05-19', 'type': 'RESET'}, {'date': '2025-03-12', 'type': 'RELEASE'}, {'date': '2025-03-28', 'type': 'RESET'}, {'date': '2025-05-08', 'type': 'RELEASE'}, {'date': '2025-05-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jerry Paugh, Professor, Associate Dean for Research, Southern California College of Optometry at Marshall B. Ketchum University'}}}}