Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-03-03 @ 6:45 PM
Study NCT ID:
NCT02298400
Status:
WITHDRAWN
Last Update Posted:
2024-04-25
First Post:
2014-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study Comparing the Comfort of Three Commercially Available Contact Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study terminated by Sponsor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2014-11-19', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contact lens wear comfort, as assessed by subject reported symptoms in diaries.', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Contact Lens Complication']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the comfort of three commercially available contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 18 years old\n* Have provided written informed consent\n* Have discomfort when wearing contact lenses\n\nExclusion Criteria:\n\n* Have an active ocular infection or significant slit lamp findings\n* Participated in any other studies in the past 30 days'}, 'identificationModule': {'nctId': 'NCT02298400', 'briefTitle': 'A Clinical Study Comparing the Comfort of Three Commercially Available Contact Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'ORA, Inc.'}, 'officialTitle': 'A Single-Center, Cross-over, Pilot Study Evaluating Acuvue® Oasys® Lenses (Senofilcon A), 30-Day Bausch + Lomb PureVision (Balafilcon A), and Clariti® 1-Day (Somofilcon A) Lenses, for Their Impact on Ocular Discomfort Induced by Exposure to the Turbo Controlled Adverse Environment™', 'orgStudyIdInfo': {'id': '14-270-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acuvue®Oasys® Lenses(senofilcon A)', 'description': 'Acuvue® Oasys® Lenses (senofilcon A) contact lenses', 'interventionNames': ['Device: Acuvue® Oasys® Lenses (senofilcon A)', 'Device: 30-Day Bausch + Lomb PureVision (balafilcon A)', 'Device: Clariti® 1-Day (Somofilcon A)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bausch + Lomb PureVision (balafilcon A)', 'description': '30-Day Bausch + Lomb PureVision (balafilcon A) contact lenses', 'interventionNames': ['Device: Acuvue® Oasys® Lenses (senofilcon A)', 'Device: 30-Day Bausch + Lomb PureVision (balafilcon A)', 'Device: Clariti® 1-Day (Somofilcon A)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clariti® 1-Day (Somofilcon A)', 'description': 'Clariti® 1-Day (Somofilcon A) contact lenses', 'interventionNames': ['Device: Acuvue® Oasys® Lenses (senofilcon A)', 'Device: 30-Day Bausch + Lomb PureVision (balafilcon A)', 'Device: Clariti® 1-Day (Somofilcon A)']}], 'interventions': [{'name': 'Acuvue® Oasys® Lenses (senofilcon A)', 'type': 'DEVICE', 'description': 'Contact lenses placed in each eye during the day for about 8 hours', 'armGroupLabels': ['Acuvue®Oasys® Lenses(senofilcon A)', 'Bausch + Lomb PureVision (balafilcon A)', 'Clariti® 1-Day (Somofilcon A)']}, {'name': '30-Day Bausch + Lomb PureVision (balafilcon A)', 'type': 'DEVICE', 'description': 'Contact lenses placed in each eye during the day for about 8 hours', 'armGroupLabels': ['Acuvue®Oasys® Lenses(senofilcon A)', 'Bausch + Lomb PureVision (balafilcon A)', 'Clariti® 1-Day (Somofilcon A)']}, {'name': 'Clariti® 1-Day (Somofilcon A)', 'type': 'DEVICE', 'description': 'Contact lenses placed in each eye during the day for about 8 hours', 'armGroupLabels': ['Acuvue®Oasys® Lenses(senofilcon A)', 'Bausch + Lomb PureVision (balafilcon A)', 'Clariti® 1-Day (Somofilcon A)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Andover Eye Associates', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ORA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}