Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT01744457
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2012-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-05', 'studyFirstSubmitDate': '2012-12-05', 'studyFirstSubmitQcDate': '2012-12-05', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coefficient of variation of tear film osmolarity after repeated measurements', 'timeFrame': 'Measurement of tear film osmolarity 3 times daily within 30 minutes for 3 consecutive days'}], 'secondaryOutcomes': [{'measure': 'Subjective symptoms assessed using the OSDI test', 'timeFrame': 'on the screening day'}, {'measure': 'Tear break up time', 'timeFrame': 'on 3 consecutive study days once a day'}, {'measure': 'Schirmer I test', 'timeFrame': 'on 3 consecutive study days once a day'}, {'measure': 'OSI (Objective Scattering Index)', 'timeFrame': 'on 3 consecutive study days once a day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tear film osmolarity', 'objective scattering index', 'tear break up time', 'Schirmer I test'], 'conditions': ['Dry Eye Syndrome']}, 'descriptionModule': {'briefSummary': 'Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged 45 and older. Although several clinical tests for the diagnosis and monitoring of DES are available, currently no gold standard for the assessment of DES exists. It has, however, been hypothesized that the assessment of tear film osmolarity may be a new and promising approach of an objective and non-invasive method for diagnosis and monitoring of treatment success.\n\nRecently, a new commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA) for the assessment of tear film osmolarity has been introduced. This instrument allows for the easy and non-invasive determination of tear film osmolarity. Unfortunately, no data about reproducibility are yet available. Consequently, the current study sets out to investigate the short time reproducibility of tear film osmolarity measurements using the TearLab® instrument.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with dry eye syndrome (DES):\n\n* Men and Women aged between 45 and 80 years, with DES defined as a pathological Schirmer I test and / or a pathological break-up time test. Schirmer I test and break up time will be tested and analyzed according to the guidelines published in the Report of the International Dry EyeWorkShop (DEWS) 2007\n* normal findings in the ophthalmic examination other than DES\n\nHealthy control group:\n\n* Men and Women aged between 45 and 80 years,\n* normal findings in the medical history and ophthalmic examination\n\nExclusion Criteria:\n\n* Abuse of drugs or alcoholic beverages\n* Participation in a clinical trial\n* Symptoms of a clinically relevant illness'}, 'identificationModule': {'nctId': 'NCT01744457', 'briefTitle': 'Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects', 'orgStudyIdInfo': {'id': 'OPHT-161009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '20 patients with dry eye syndrome', 'description': 'Patients with dry eye syndrome defined as outlined in the inclusion and exclusion criteria', 'interventionNames': ['Device: Measurement of tear film osmolarity with the TearLab® instrument', 'Other: Schirmer I test', 'Other: Tear break up time', 'Device: Optical Quality Analysis System', 'Other: Ocular Surface Disease Index']}, {'type': 'OTHER', 'label': '20 healthy control subjects', 'description': 'age- and sex-matched controls', 'interventionNames': ['Device: Measurement of tear film osmolarity with the TearLab® instrument', 'Other: Schirmer I test', 'Other: Tear break up time', 'Device: Optical Quality Analysis System', 'Other: Ocular Surface Disease Index']}], 'interventions': [{'name': 'Measurement of tear film osmolarity with the TearLab® instrument', 'type': 'DEVICE', 'armGroupLabels': ['20 healthy control subjects', '20 patients with dry eye syndrome']}, {'name': 'Schirmer I test', 'type': 'OTHER', 'armGroupLabels': ['20 healthy control subjects', '20 patients with dry eye syndrome']}, {'name': 'Tear break up time', 'type': 'OTHER', 'armGroupLabels': ['20 healthy control subjects', '20 patients with dry eye syndrome']}, {'name': 'Optical Quality Analysis System', 'type': 'DEVICE', 'description': 'Measurement of the objective scattering index (OSI)', 'armGroupLabels': ['20 healthy control subjects', '20 patients with dry eye syndrome']}, {'name': 'Ocular Surface Disease Index', 'type': 'OTHER', 'armGroupLabels': ['20 healthy control subjects', '20 patients with dry eye syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Department of Clinical Pharmacology, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. PD Dr.', 'investigatorFullName': 'Gerhard Garhofer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}