Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-17 @ 11:56 PM
Study NCT ID:
NCT01319604
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2011-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SENSIMED Triggerfish
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-07', 'studyFirstSubmitDate': '2011-03-18', 'studyFirstSubmitQcDate': '2011-03-18', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between study device signal and tonometer reading', 'timeFrame': 'during 24 hours of study device wear'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.', 'detailedDescription': '60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent for the investigation\n* Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes\n* Age 18-85\n* Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation\n\nExclusion Criteria:\n\n* Patients not able to understand the character and individual consequences of the investigation\n* Patients with contraindications for silicone contact lens wear\n* Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring\n* Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma\n* Severe dry eye\n* Patients who have had ocular surgery within the last 3 months\n* Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation\n* Allergy to corneal anaesthesia\n* Simultaneous participation in other clinical research'}, 'identificationModule': {'nctId': 'NCT01319604', 'briefTitle': 'SENSIMED Triggerfish', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sensimed AG'}, 'officialTitle': 'Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring', 'orgStudyIdInfo': {'id': '10/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study device during 3 hours', 'interventionNames': ['Device: SENSIMED Triggerfish']}, {'type': 'EXPERIMENTAL', 'label': 'Study device during 6 hours', 'interventionNames': ['Device: SENSIMED Triggerfish']}, {'type': 'EXPERIMENTAL', 'label': 'Study device during 9 hours', 'interventionNames': ['Device: SENSIMED Triggerfish']}, {'type': 'EXPERIMENTAL', 'label': 'Study device during 12 hours', 'interventionNames': ['Device: SENSIMED Triggerfish']}, {'type': 'EXPERIMENTAL', 'label': 'Study device during 15 hours', 'interventionNames': ['Device: SENSIMED Triggerfish']}, {'type': 'EXPERIMENTAL', 'label': 'Study device during 18 hours', 'interventionNames': ['Device: SENSIMED Triggerfish']}, {'type': 'EXPERIMENTAL', 'label': 'Study device during 21 hours', 'interventionNames': ['Device: SENSIMED Triggerfish']}, {'type': 'EXPERIMENTAL', 'label': 'Study device during 24 hours', 'interventionNames': ['Device: SENSIMED Triggerfish']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tonometric assessment during 24 hours', 'interventionNames': ['Device: Tonometer']}], 'interventions': [{'name': 'SENSIMED Triggerfish', 'type': 'DEVICE', 'description': 'Soft contact lens-based device for the continuous monitoring of IOP fluctuations', 'armGroupLabels': ['Study device during 12 hours', 'Study device during 15 hours', 'Study device during 18 hours', 'Study device during 21 hours', 'Study device during 24 hours', 'Study device during 3 hours', 'Study device during 6 hours', 'Study device during 9 hours']}, {'name': 'Tonometer', 'type': 'DEVICE', 'description': 'Tonometric assessment of IOP', 'armGroupLabels': ['Tonometric assessment during 24 hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'University Hospital Glostrup', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politècnic la Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Milko Iliev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sensimed AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}