Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-27 @ 10:55 AM
Study NCT ID:
NCT01206361
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2010-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real World Data Study Assessing The Persistency Of Xalacom And The Other Fixed Dose Combination Products, Duotrav And Ganfort, In The United Kingdom
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571753', 'term': 'Xalacom'}, {'id': 'C571754', 'term': 'Duotrav'}, {'id': 'C571755', 'term': 'Ganfort'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2015}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2010-08-26', 'studyFirstSubmitQcDate': '2010-09-20', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency distribution of persistent and non-persistent patients across study cohorts', 'timeFrame': '12 months'}, {'measure': 'Frequency distribution of switchers, re-starters and discontinuing patients as well as patients commencing add-on therapy across the study cohorts', 'timeFrame': '12 months'}, {'measure': 'Time to discontinuation of each cohort', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Age and sex: Townsend Score of social deprivation, time since first THIN diagnosis of glaucoma or ocular hypertension', 'timeFrame': '12 months'}, {'measure': 'Procedures: Laser, Trabeculectomy, viscocanalostomy, deep sclerectomy', 'timeFrame': '12 months'}, {'measure': 'Ocular Pharmacological Treatments: Beta-blockers and Alpha-agonists', 'timeFrame': '12 months'}, {'measure': 'Prostaglandin mono-therapies', 'timeFrame': '12 months'}, {'measure': 'The cohort of patients which were evaluated in this study were investigated for the presence of history of disease for asthma, cardiovascular disease, diabetes, renal failure and systemic hypertension. The number of patients in each cohort were', 'timeFrame': '12 months'}, {'measure': 'presented who had had (i) a 12 month history of any of the diseases or (ii) had had a history of any of the diseases.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Real world', 'observational', 'retrospective', 'database analysis'], 'conditions': ['Glaucoma', 'Ocular Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6111145&StudyName=Real%20World%20Data%20Study%20Assessing%20The%20Persistency%20Of%20Xalacom%20And%20The%20Other%20Fixed%20Dose%20Combination%20Products%2C%20Duotrav%20And%20Ganfort%2C%20In%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis is that there is no difference in persistency between Xalacom and the alternative fixed dose combination products (Duotrav and Ganfort) over a 12 month period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who had received a prescription for either Xalacom, Ganfort and DuoTrav, \\> 18 years old, diagnosed with glaucoma or ocular hypertension, registered at the primary care practice for \\> 12 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who had received a prescription for either Xalacom, Ganfort and DuoTrav\n* Greater than 18 years old\n* Diagnosed with glaucoma or ocular hypertension\n* Registered at the primary care practice for \\> 12 months\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01206361', 'briefTitle': 'Real World Data Study Assessing The Persistency Of Xalacom And The Other Fixed Dose Combination Products, Duotrav And Ganfort, In The United Kingdom', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Persistence Of Use Of Topical Prostaglandin Fixed Dose Combination In The United Kingdom Primary Care: An Observational Study In Thin', 'orgStudyIdInfo': {'id': 'A6111145'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'fixed dose prostaglandin combination', 'interventionNames': ['Drug: XALACOM', 'Drug: Duotrav', 'Drug: Ganfort']}], 'interventions': [{'name': 'XALACOM', 'type': 'DRUG', 'description': 'Xalacom eye drops', 'armGroupLabels': ['fixed dose prostaglandin combination']}, {'name': 'Duotrav', 'type': 'DRUG', 'description': 'Duotrav eye drops', 'armGroupLabels': ['fixed dose prostaglandin combination']}, {'name': 'Ganfort', 'type': 'DRUG', 'description': 'Ganfort eye drops', 'armGroupLabels': ['fixed dose prostaglandin combination']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}