Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-01-02 @ 8:34 AM
Study NCT ID:
NCT00757835
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2008-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000077338', 'term': 'Latanoprost'}], 'ancestors': [{'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2008-09-19', 'studyFirstSubmitQcDate': '2008-09-22', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of side effects with the two medications', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['24-hour IOP', 'exfoliative glaucoma', 'travoprost/timolol', 'latanoprost/timolol', 'fixed combinations'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has XFG and is older than 29 years\n* The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)\n* Patient can be safely washed out without risk for significant deterioration\n* Distance best corrected Snelen visual acuity better than 0.1\n* No contraindication to prostaglandins or β-blockers\n* No history of lack of response (\\<10% reduction) to any medication\n* Patient can understand the instructions and comply to medications\n* Open normal appearing angles\n* No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc\n\nExclusion Criteria:\n\n* History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses\n* Patient is a female of childbearing potential or lactating mother'}, 'identificationModule': {'nctId': 'NCT00757835', 'briefTitle': '24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': '24-hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma', 'orgStudyIdInfo': {'id': 'A6219'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Travoprost/timolol therapy', 'description': 'treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring.', 'interventionNames': ['Drug: treatment with latanoprost/timolol fixed combination', 'Drug: latanoprost/timolol fixed combination drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Latanoprost/timolol therapy', 'description': 'Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring.', 'interventionNames': ['Drug: treatment with latanoprost/timolol fixed combination', 'Drug: latanoprost/timolol fixed combination drops']}], 'interventions': [{'name': 'treatment with latanoprost/timolol fixed combination', 'type': 'DRUG', 'description': 'dosing in the evening with the two fixed combinations', 'armGroupLabels': ['Latanoprost/timolol therapy', 'Travoprost/timolol therapy']}, {'name': 'latanoprost/timolol fixed combination drops', 'type': 'DRUG', 'description': 'once in the evening', 'armGroupLabels': ['Latanoprost/timolol therapy', 'Travoprost/timolol therapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Anastasios G Konstas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glaucoma Unit, 1st University Department of Ophthalmology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Ophthalmology', 'investigatorFullName': 'AGP Konstas', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}