Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 12:42 PM
Study NCT ID:
NCT00372034
Status:
COMPLETED
Last Update Posted:
2009-04-07
First Post:
2006-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Punctal Plugs on Tear Volume and Osmolality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-06', 'studyFirstSubmitDate': '2006-09-03', 'studyFirstSubmitQcDate': '2006-09-05', 'lastUpdatePostDateStruct': {'date': '2009-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular comfort after 6 hours of contact lens wear'}, {'measure': 'Dryness sensation after 6 hours of contact lens wear'}, {'measure': 'Tear film volume before and after 6 hours of contact lens wear'}], 'secondaryOutcomes': [{'measure': 'Objective ocular sensitivity after 6 hours of contact lens wear'}, {'measure': 'Tear film and contact lens osmolality after 6 hours of contact lens wear'}]}, 'conditionsModule': {'keywords': ['contact lenses', 'intolerance', 'punctal plugs', 'tear volume', 'Intolerance to contact lens wear due to dryness symptoms'], 'conditions': ['Dry Eye Syndromes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity.', 'detailedDescription': '50% of contact lens wearers have dryness/discomfort during contact lens wear. Significant decreases in lipid layer and tear film break up time during contact lens wear have been reported, leading to excessive evaporation, reduced tear volume and an increase in osmolality.\n\nSimilar tear film changes occur with Dry Eye Disease. A commonly used therapy in treating dry eye is the insertion of punctal plugs to increase tear volume and ease dry eye symptoms. Punctal plugs block the tear drainage system, and often increase tear stability, and improve ocular surface health.\n\nThis study will evaluate the role of tear volume in discomfort and dryness sensations during contact lens wear, and the possible influence on osmolality and ocular surface sensitivity. Collagen punctal plugs will be used for this study, as these allow a temporary (3-14 days) occlusion of the ocular drainage system, are easily removed if necessary and are inserted with minimal risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age\n\nExclusion Criteria:\n\n* Corneal refractive surgery\n* Contraindications to contact lens wear\n* Latex allergy\n* Corneal hypoesthesia\n* Active corneal infection\n* Acute or sub-acute inflammation or infection of the anterior chamber of the eye'}, 'identificationModule': {'nctId': 'NCT00372034', 'briefTitle': 'The Effect of Punctal Plugs on Tear Volume and Osmolality', 'organization': {'class': 'OTHER', 'fullName': 'The University of New South Wales'}, 'orgStudyIdInfo': {'id': 'VRRP2005-018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Temporary Collagen Inserts', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2033', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Vision CRC, Institute for Eye Research, School of Optometry and Vision Science', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Ulrike Stahl, Dipl-Optom', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VisionCRC, School of Optometry and Vision Science, Institute for Eye Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of New South Wales', 'class': 'OTHER'}}}}