Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-01-02 @ 1:19 PM
Study NCT ID:
NCT00732004
Status:
COMPLETED
Last Update Posted:
2009-07-02
First Post:
2008-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-30', 'studyFirstSubmitDate': '2008-08-08', 'studyFirstSubmitQcDate': '2008-08-08', 'lastUpdatePostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Myopia', 'Hyperopia']}, 'descriptionModule': {'briefSummary': 'The principal aim of this project is to determine the time course of development of contact lens and contact lens case contamination during daily wear of silicone hydrogel lenses. The secondary aim of the study is to determine whether the time course of development of contact lens and contact lens case contamination varies between two different contact lens care systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Distance contact lens prescription between +8.00 and -10.00D.\n* Cylindrical component of refractive error no greater than 1.25D in either eye.\n* Vision correctable to 6/12 (0.30 logMAR) or better in each eye.\n* Healthy normal eyes without anterior segment infection, inflammation or abnormality, or significant slitlamp findings.\n\nExclusion Criteria:\n\n* Concurrent ocular medication\n* Eye injury or surgery within twelve weeks immediately prior to enrolment.\n* Current ocular irritation that would preclude contact lens fitting.\n* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.\n* Pregnant, lactating or planning a pregnancy.'}, 'identificationModule': {'nctId': 'NCT00732004', 'briefTitle': 'Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses', 'organization': {'class': 'OTHER', 'fullName': 'University of Melbourne'}, 'orgStudyIdInfo': {'id': 'H08 002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Group 1', 'interventionNames': ['Device: Silicone Hydrogel Contact Lenses']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Group 2', 'interventionNames': ['Device: 1x PMBH preserved MPS']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Group 3', 'interventionNames': ['Device: 1x Polyquad/Aldox MPS']}], 'interventions': [{'name': 'Silicone Hydrogel Contact Lenses', 'type': 'DEVICE', 'armGroupLabels': ['1']}, {'name': '1x PMBH preserved MPS', 'type': 'DEVICE', 'armGroupLabels': ['2']}, {'name': '1x Polyquad/Aldox MPS', 'type': 'DEVICE', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3053', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Clinical Vision Research Australia', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Melbourne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinical Vision Research Australia', 'class': 'OTHER'}, {'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Carol Lakkis', 'oldOrganization': 'Clinical Vision Research Australia'}}}}