Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-31 @ 6:38 PM
Study NCT ID:
NCT00597467
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2007-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Soft Contact Lens Use With 7 Day Extended Wear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2007-12-27', 'studyFirstSubmitQcDate': '2008-01-09', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of serious and significant AEs', 'timeFrame': '1 Year', 'description': 'Frequency of serious and significant AEs defined as a composite of infiltrates of higher than grade 2 and/or infiltrates with any overlying staining, peripheral ulcer, and loss of two or more lines of visual acuity at any time during the trial'}], 'secondaryOutcomes': [{'measure': 'Contact Lens Visual Acuity', 'timeFrame': '1 Year', 'description': 'Contact lens visual acuity was assessed using LogMAR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['myopia', 'hyperopia', 'extended wear', 'ametropia'], 'conditions': ['Ametropia']}, 'descriptionModule': {'briefSummary': 'To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.', 'detailedDescription': 'To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses in this open-labeled randomized study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Be at least 18 years of age as of the date of evaluation.\n2. Require lens powers between -0.50 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear lenses in both eyes.\n3. Be correctable to visual acuities of at least 20/25 in each eye with spectacles.\n4. Be in good general health, based on his/her knowledge.\n5. Be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments.\n6. Possess wearable and visually functional eyeglasses.\n\nExclusion Criteria:\n\n1. Previously unsuccessful with contact lens wear.\n2. Rigid gas permeable contact lens wear within the past 12 months.\n3. Previous refractive surgery; current or previous orthokeratology treatment.\n4. Subject is wearing lenses in a modified monovision modality (multifocal lens in one eye). NOTE: subjects may not wear monovision lenses at any time during the study unless they are wearing spherical monovision lenses prior to enrollment.\n5. Aphakia, keratoconus or an irregular cornea.\n6. A known history of corneal hypoesthesia\n7. Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.\n8. Ocular or systemic disease or need for medication which might interfere with contact lens wear. i.e., Sjögren's syndrome, type II diabetes, etc.\n9. Slit lamp findings that would contraindicate contact lens wear, including but not limited to:\n\n * History of corneal ulcer, corneal infiltrates or fungal infections.\n * Pterygium, pinguecula or corneal scars within the visual axis\n * Pathological dry eye or associated findings (examples: Sjögren's syndrome, lupus erythematosus, sclerodermia)\n * Neovascularization or ghost vessels \\> 1mm in from the limbus\n * Seborrheic eczema, seborrheic conjunctivitis\n * History of papillary conjunctivitis greater than Grade 2 (Mild)\n * Anterior uveitis or iritis (past or present)\n10. Known sensitivity to the care systems used in this study.\n11. Poor personal hygiene\n12. Current pregnancy or is lactating (to the best of the subject's knowledge) or subject is planning pregnancy within the next 13 months.\n13. Any active participation in another clinical study within 30 days prior to this study.\n14. Subject is a member, relative or household member of the office staff, including the investigator(s).\n\nSubjects must read, indicate understanding of, and sign the Informed Consent Form."}, 'identificationModule': {'nctId': 'NCT00597467', 'briefTitle': 'Study of Soft Contact Lens Use With 7 Day Extended Wear', 'organization': {'class': 'INDUSTRY', 'fullName': 'CooperVision International Limited (CVIL)'}, 'officialTitle': 'An Open-Labeled, Multi-Center, Randomized Investigation of the VISA (Comfilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens for Use in a 7 Day Extended Wear Regimen', 'orgStudyIdInfo': {'id': 'CVI060105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Contact Lenses', 'description': 'VISA (comfilcon A) Silicone Hydrogel Soft contact lens', 'interventionNames': ['Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Contact Lenses', 'description': 'Acuvue 2 Soft Contact Lens', 'interventionNames': ['Device: Acuvue 2 Soft Contact Lens']}], 'interventions': [{'name': 'VISA (comfilcon A) Silicone Hydrogel Soft contact lens', 'type': 'DEVICE', 'otherNames': ['Biofinity (comfilcon A)'], 'description': 'Test device', 'armGroupLabels': ['Test Contact Lenses']}, {'name': 'Acuvue 2 Soft Contact Lens', 'type': 'DEVICE', 'description': 'Control device', 'armGroupLabels': ['Control Contact Lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91941', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'La Mesa Vision Care Center', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': '(Private Practice)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92129', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Drs. Cook, Reeder and Associates', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': '(Private Practice)', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80521', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Eye Care Associates, P.C.', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Eola Eyes', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': '(Private Practice)', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96815', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Kato & Shoji Optometrists', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96797', 'city': 'Waipahu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Eye Care Associates of Hawaii', 'geoPoint': {'lat': 21.38667, 'lon': -158.00917}}, {'zip': '60453', 'city': 'Oak Lawn', 'state': 'Illinois', 'country': 'United States', 'facility': 'Davis Eyecare Associates', 'geoPoint': {'lat': 41.71087, 'lon': -87.75811}}, {'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': '(Private Practice)', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}, {'zip': '48823', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Vision Care Associates', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '63144', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Koetting Associates Inc.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '03301', 'city': 'Concord', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Concord Ophthalmological Associates', 'geoPoint': {'lat': 43.20814, 'lon': -71.53757}}, {'zip': '14482', 'city': 'Le Roy', 'state': 'New York', 'country': 'United States', 'facility': 'Place Optical Company Inc', 'geoPoint': {'lat': 42.97839, 'lon': -77.98418}}, {'zip': '45701', 'city': 'Athens', 'state': 'Ohio', 'country': 'United States', 'facility': 'Quinn Quinn & Associates', 'geoPoint': {'lat': 39.32924, 'lon': -82.10126}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Western Reserve Vision Care', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Professional Eye Care Associates', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37027', 'city': 'Brentwood', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Primary Eyecare Group, P.C.', 'geoPoint': {'lat': 36.03312, 'lon': -86.78278}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': '(Private Practice)', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98023', 'city': 'Federal Way', 'state': 'Washington', 'country': 'United States', 'facility': 'Twin Lakes Vision', 'geoPoint': {'lat': 47.32232, 'lon': -122.31262}}, {'zip': '82070', 'city': 'Laramie', 'state': 'Wyoming', 'country': 'United States', 'facility': 'Snowy Range Vision Center', 'geoPoint': {'lat': 41.31137, 'lon': -105.5911}}], 'overallOfficials': [{'name': 'William Gleason, OD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'FRS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CooperVision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}