Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-27 @ 10:29 AM
Study NCT ID:
NCT00346593
Status:
COMPLETED
Last Update Posted:
2007-02-12
First Post:
2006-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2007-02-08', 'studyFirstSubmitDate': '2006-06-29', 'studyFirstSubmitQcDate': '2006-06-29', 'lastUpdatePostDateStruct': {'date': '2007-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens during continuous wear (up to 30 nights) over a period of 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has had an oculo-visual examination in the last 2 years.\n* Is correctable to at least 6/7.5 distance visual acuity in each eye with spherical contact lenses.\n* Is a current soft contact lens wearer.\n* Has no clinically significant anterior eye findings.\n* Has no other active ocular disease.\n\nExclusion Criteria:\n\n* Has any systemic disease that might interfere with contact lens wear\n* Is using any systemic or topical medications that will affect ocular health.\n* Has any pre-existing ocular irritation that would preclude contact lens fitting.\n* Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.\n* Has undergone corneal refractive surgery.\n* Is pregnant, lactating or planning a pregnancy.'}, 'identificationModule': {'nctId': 'NCT00346593', 'briefTitle': 'Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear', 'organization': {'class': 'OTHER', 'fullName': 'University of Melbourne'}, 'orgStudyIdInfo': {'id': 'H03 010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Silicone hydrogel contact lens', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3053', 'city': 'Carlton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Clinical Vision Research Australia', 'geoPoint': {'lat': -37.8, 'lon': 144.96667}}], 'overallOfficials': [{'name': 'Carol Lakkis, BScOptom PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Vision Research Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Melbourne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Vision Research Australia', 'class': 'OTHER'}, {'name': 'Cooper Companies', 'class': 'INDUSTRY'}]}}}