Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-30 @ 3:38 AM
Study NCT ID:
NCT00972257
Status:
COMPLETED
Last Update Posted:
2014-05-12
First Post:
2009-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'C062765', 'term': 'dorzolamide'}, {'id': 'D013999', 'term': 'Timolol'}, {'id': 'D000068438', 'term': 'Brimonidine Tartrate'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-09', 'studyFirstSubmitDate': '2009-09-03', 'studyFirstSubmitQcDate': '2009-09-03', 'lastUpdatePostDateStruct': {'date': '2014-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Assess fluctuation of 24-hour pressure', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['24-hour IOP control', 'primary open-angle glaucoma', 'brimonidine/timolol', 'dorzolamide/timolol'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '21960068', 'type': 'DERIVED', 'citation': 'Konstas AG, Quaranta L, Yan DB, Mikropoulos DG, Riva I, Gill NK, Barton K, Haidich AB. Twenty-four hour efficacy with the dorzolamide/timolol-fixed combination compared with the brimonidine/timolol-fixed combination in primary open-angle glaucoma. Eye (Lond). 2012 Jan;26(1):80-7. doi: 10.1038/eye.2011.239. Epub 2011 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'The proposed study will compare for the first time the quality of 24-hour IOP control with Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may determine the real efficacy of the two fixed combinations and the design of the proposed study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less than might be anticipated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '29 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive, newly diagnosed or previously untreated POAG patients\n* Patients with typical glaucomatous disc, or visual field damage\n* Patient must have IOP (at 10:00 ± 1 hour)greater than 25 mm Hg\n\nExclusion Criteria:\n\n* Uncontrolled glaucoma\n* Distance best corrected Snellen visual acuity worse than 1/10\n* Contraindications to brimonidine or dorzolamide and β-blockers\n* History of lack of response (\\<10% morning IOP reduction) to any medication\n* Patient can not understand the instructions and adhere to medications\n* Patient is a female of childbearing potential or lactating mother\n* Prior surgery, past use of steroids (within 2 months)\n* Severe dry eyes and use of contact lenses\n* History of non-adherence\n* Patients with closed angles'}, 'identificationModule': {'nctId': 'NCT00972257', 'briefTitle': '24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Quality of 24-hour Intraocular Pressure Control Obtained With Dorzolamide/Timolol Fixed Combination (DTFC) Compared With the Brimonidine/Timolol Fixed Combination (BTFC) in Subjects With Primary Open-angle Glaucoma', 'orgStudyIdInfo': {'id': 'A5132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Drug: Dorzolamide/Timolol', 'interventionNames': ['Drug: treatment with dorzolamide/timolol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment with Brimonidine/Timolol', 'interventionNames': ['Drug: treatment with brimonidine/timolol']}], 'interventions': [{'name': 'treatment with dorzolamide/timolol', 'type': 'DRUG', 'description': '24-hour IOP control with the two fixed combinations', 'armGroupLabels': ['Drug: Dorzolamide/Timolol']}, {'name': 'treatment with brimonidine/timolol', 'type': 'DRUG', 'description': '24-hour pressure control with brimonidine/timolol', 'armGroupLabels': ['Treatment with Brimonidine/Timolol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '546 36', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Glaucoma Unit, 1st University Dept of Ophthalmology', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Anastasios Konstas, MD, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Glaucoma Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Ophthalmology', 'investigatorFullName': 'AGP Konstas', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}