Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01491867
Status:
COMPLETED
Last Update Posted:
2013-03-22
First Post:
2011-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Intraocular Pressure (IOP) Measurement and Ability to Detect Treatment Effect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-20', 'studyFirstSubmitDate': '2011-12-12', 'studyFirstSubmitQcDate': '2011-12-13', 'lastUpdatePostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuous intraocular pressure (IOP) measurement', 'timeFrame': '3 months', 'description': '24-h intraocular pressure (IOP) decrease induced by travoprost 0.003% 1/day as measured with Goldmann tonometry and Sensimed contact lens sensor'}], 'secondaryOutcomes': [{'measure': 'Continuous intraocula pressure (IOP) Measurement', 'timeFrame': '3 months', 'description': 'Reproducibility of intraocular pressure measurements with the Sensimed contact lens sensor methods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intraocular pressure'], 'conditions': ['Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'Continuous intraocular pressure (IOP) measurement with a contact lens sensor may provide more information on the drug-related IOP change than 24-hour IOP measurement with Goldmann applanation tonometry (GAT.', 'detailedDescription': '* Participants are washed ot from all glaucoma medication for 6 weeks\n* one eye per participant is investigated (study eye)\n* 24-h intraocular pressure (IOP) curve is obtained with Goldmann tonometry and Sensimed contact lens sensor tonometry twice, in 14 days\n* for Sensimed contact lens curves median values (in arbitrary units), for Goldmann applanation tonometry, mean and SD values are used to characterize the curves, for comparisions % changes are used for the corresponding time periods\n* treatment (travoprost 0.005% 1/day) is given to all eyes for 3 months 24-h Goldmann and Sensimed IOP curves are repeated\n* IOP curves are determined in arbitrary units and mmHg, respectively, and compared for reproducibility (untreated phase) and relative (%)change (untreated curve vs. under treatment curve) with both methods, respectively'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary open-angle glaucoma (POAG), ocular hypertension(OHT)\n* 18 years or older\n* C/D \\<= 0.7\n* no risk for visual field damage\n* IOP \\> 22 mmHg\n\nExclusion Criteria:\n\n* Pregnancy and lactation\n* Known intolerance to travoprost, topical anesthetic\n* Previous ocular surgery at any time\n* Previous ocular laser treatment within 1 year'}, 'identificationModule': {'nctId': 'NCT01491867', 'briefTitle': 'Continuous Intraocular Pressure (IOP) Measurement and Ability to Detect Treatment Effect', 'organization': {'class': 'OTHER', 'fullName': 'Semmelweis University'}, 'officialTitle': 'Evaluation of Continuous IOP Measurement and the Influence of Drug Induced IOP Decrease on the Measurement', 'orgStudyIdInfo': {'id': '4481/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Travoprost arm', 'description': 'All individuals receive travoprost 0.003% 1/day in both eyes after 6 weeks wash-out for 3 months', 'interventionNames': ['Drug: travoprost 0.003%']}], 'interventions': [{'name': 'travoprost 0.003%', 'type': 'DRUG', 'description': 'Instillation of travoprost 0.003% 1/die in both eyes for 3 months', 'armGroupLabels': ['Travoprost arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1083', 'city': 'Budapest', 'state': 'Pest County', 'country': 'Hungary', 'facility': 'Departement of Ophthalmology'}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Gabor Hollo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Semmelweis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Gabor Hollo', 'investigatorAffiliation': 'Semmelweis University'}}}}