Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-04 @ 9:58 PM
Study NCT ID:
NCT00441233
Status:
COMPLETED
Last Update Posted:
2008-01-09
First Post:
2007-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance of Extended Wear Silicone Hydrogel Lenses
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': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-27', 'studyFirstSubmitDate': '2007-02-27', 'studyFirstSubmitQcDate': '2007-02-27', 'lastUpdatePostDateStruct': {'date': '2008-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens over a period of 6 months of extended wear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is correctable to at least 6/9 distance visual acuity in each eye with spherical contact lenses.\n* Is a current daily wear 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': 'NCT00441233', 'briefTitle': 'Clinical Performance of Extended Wear Silicone Hydrogel Lenses', 'organization': {'class': 'OTHER', 'fullName': 'University of Melbourne'}, 'orgStudyIdInfo': {'id': 'H07 001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Silicone hydrogel contact lens', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3053', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Clinical Vision Research Australia', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Carol Lakkis, BScOptom, PhD, PGCertOcTher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Vision Research Australia, University of Melbourne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Melbourne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Menicon Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Clinical Vision Research Australia', 'class': 'OTHER'}]}}}