Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT05498103
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2022-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Methazolamide to Lower Intraocular Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-05-21', 'mcpReleaseN': 5, 'releaseDate': '2025-05-07'}], 'estimatedResultsFirstSubmitDate': '2025-05-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008704', 'term': 'Methazolamide'}], 'ancestors': [{'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2022-08-09', 'studyFirstSubmitQcDate': '2022-08-09', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent IOP change at each follow-up Visit', 'timeFrame': 'Day 1 (Pre-dosing, then 4- and 8- hours post dosing), Day 7 (Pre-dosing, then 4- and 8- hours post dosing), Day 14 (Pre-dosing, then 4- and 8- hours post dosing)', 'description': 'IOP measure is measured using Goldmann Tonometry. IOP is measured in mmHg with a normal range from 12 mmHg to 22 mmHg.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Methazolamide', 'Primary Open Angle Glaucoma'], 'conditions': ['Glaucoma, Open-Angle']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of methazolamide, 25 mg or 50 mg tablets once a day for a week than twice a day for a week, on lowering intraocular pressure and the safety of methazolamide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females between 50 and 90 years old\n* Current diagnosis of open angle glaucoma (OAG) in both eyes\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Glaucoma other than OAG\n* Severe or end-stage glaucoma (cup to disc ratio \\>0.8 or Mean Deviation on Visual Field worse than -12)\n* Pregnant or breast-feeding women'}, 'identificationModule': {'nctId': 'NCT05498103', 'briefTitle': 'Use of Methazolamide to Lower Intraocular Pressure', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Use of Methazolamide to Lower Intraocular Pressure', 'orgStudyIdInfo': {'id': '22-0721'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methazolamide 25 mg', 'description': 'Once a day \\[q.d\\] in the morning for 1 week, Twice a day \\[b.i.d.\\] in the morning and evening for 1 week', 'interventionNames': ['Drug: Methazolamide 25 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methazolamide 50 mg', 'description': 'Once a day \\[q.d\\] in the morning for 1 week, Twice a day \\[b.i.d.\\] in the morning and evening for 1 week', 'interventionNames': ['Drug: Methazolamide 50 MG']}], 'interventions': [{'name': 'Methazolamide 25 MG', 'type': 'DRUG', 'description': '25 mg tablets', 'armGroupLabels': ['Methazolamide 25 mg']}, {'name': 'Methazolamide 50 MG', 'type': 'DRUG', 'description': '50 mg tablets', 'armGroupLabels': ['Methazolamide 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Sue Anschutz-Rodgers Eye Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Malik Y. Kahook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}