Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-31 @ 6:18 PM
Study NCT ID:
NCT01125306
Status:
UNKNOWN
Last Update Posted:
2012-03-16
First Post:
2010-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency of XAL-EASE Device in Glaucoma and/or Ocular Hypertension (OHT) Patients, Treated With Xalatan or Xalacom
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-15', 'studyFirstSubmitDate': '2010-05-16', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consumption of Xalatan/Xalacom bottles per year per patient.', 'timeFrame': '12 months.'}], 'secondaryOutcomes': [{'measure': 'Evaluating cost of Xalatan/Xalacom eye drops use per year with Xal-Ease', 'timeFrame': '12 months'}, {'measure': 'Characterizing the optimal conditions for proper usage of the Xal-Ease device', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug consumption', 'The Xal-Ease device', "Patient's compliance", 'Using a novel Pfizer-Pharmacia device to facilitate the Xalatan/Xalacom instillation and to avoid loss of eye drops'], 'conditions': ['Glaucoma', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '17208672', 'type': 'BACKGROUND', 'citation': 'Semes L, Shaikh AS. Evaluation of the Xal-Ease latanoprost delivery system. Optometry. 2007 Jan;78(1):30-3. doi: 10.1016/j.optm.2006.06.016.'}, {'pmid': '19882583', 'type': 'RESULT', 'citation': 'Nordmann JP, Baudouin C, Bron A, Denis P, Rouland JF, Sellem E, Renard JP. Xal-Ease: impact of an ocular hypotensive delivery device on ease of eyedrop administration, patient compliance, and satisfaction. Eur J Ophthalmol. 2009 Nov-Dec;19(6):949-56. doi: 10.1177/112067210901900609.'}], 'seeAlsoLinks': [{'url': 'http://www.xalatan.com/tools/xal-ease.aspx', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Xal-Ease is a novel Pfizer-Pharmacia device aimed to significantly facilitate the Xalatan/Xalacom instillation and to avoid loss of Xalatan/Xalacom eye drops due to incorrect instillation.\n\nPatients on Xalatan/Xalacom who have consumed more than one bottle per month within a year according to consumption data drawn from the Clalit Health Services database, will use the Xal-Ease device for a year. The device is expected to reduce consumption of bottles and result in saving money for both patients and medical care providers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with glaucoma or hypertension treated with Xalatan/Xalacom who have consumed more than one bottle per month within a year prior to initiation of the study.\n\nExclusion Criteria:\n\n* Patients younger than 18 years,\n* Patients with severe manual disabilities,\n* Patients with impaired cognition and mentality.'}, 'identificationModule': {'nctId': 'NCT01125306', 'briefTitle': 'Efficiency of XAL-EASE Device in Glaucoma and/or Ocular Hypertension (OHT) Patients, Treated With Xalatan or Xalacom', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'orgStudyIdInfo': {'id': 'GLAUCOMA/XAL EASE 1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Xal-Ease', 'type': 'DEVICE', 'otherNames': ['Xal-Ease as a Pfizer-Pharmacia device.'], 'description': 'Xal-Ease device used to facilitate application of Xalatan/Xalacom eye drops.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44281', 'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ronit Nesher, MD', 'role': 'CONTACT', 'email': 'nesher.ronit@clalit.org.il', 'phone': '972-9747555', 'phoneExt': '2774'}, {'name': 'Ronit Nesher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ophthalmology department, Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}