Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-01 @ 11:30 PM
Study NCT ID:
NCT01362868
Status:
TERMINATED
Last Update Posted:
2011-11-09
First Post:
2011-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'whyStopped': 'Too low effect on the output and low rate of responders', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-08', 'studyFirstSubmitDate': '2011-05-27', 'studyFirstSubmitQcDate': '2011-05-27', 'lastUpdatePostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT', 'timeFrame': '30-45 min after WDT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Triggerfish', 'Water drinking test'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.', 'detailedDescription': "32 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 4-6-hour continuous IOP monitoring with SENSIMED Triggerfish® following water drinking test (WDT). SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Sensor fitting in the eye will then be evaluated every 60 minutes, until no more spontaneous Sensor movement and rotation are observed. Then IOP will be measured on the contra lateral eye using Goldmann tonometer and the subjects will be asked to drink 1 liter of water within 5 minutes.\n\nAfter the water drinking, IOP will be measured on the contra lateral eye 10 minutes after the beginning of the test then every 5 minutes until returned to normal. The IOP will be measured again every 20 minutes until 2 hours after the water drinking."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer without previous ocular medical history\n* 18 years or more at inclusion\n* Maximal weight: 100kg\n* BMI lower or equal to 30 kg/m2\n* Subjects having provided informed consent\n\nExclusion Criteria:\n\n* Silicone allergy\n* Cardiovascular disease\n* Diabetes\n* Narrow or closed iridocorneal angle'}, 'identificationModule': {'nctId': 'NCT01362868', 'briefTitle': 'Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sensimed AG'}, 'officialTitle': 'Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation', 'orgStudyIdInfo': {'id': '1012'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SENSIMED Triggerfish®', 'type': 'DEVICE', 'description': 'Soft contact lens-based device for the continuous monitoring of IOP fluctuations'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1006', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Unité de Glaucome, Clinique de Montchoisi', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'André Mermoud, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique de Montchoisi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sensimed AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Pr. André Mermoud', 'oldOrganization': 'Clinique de Montchoisi'}}}}