Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT00650702
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2008-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'dispFirstSubmitDate': '2011-02-23', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2008-03-27', 'dispFirstSubmitQcDate': '2011-02-23', 'studyFirstSubmitQcDate': '2008-04-01', 'dispFirstPostDateStruct': {'date': '2011-03-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP change from baseline', 'timeFrame': '12 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma, ocular hypertension, IOP'], 'conditions': ['Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 yrs with open-angle glaucoma or ocular hypertension\n* Subjects who have a best-corrected visual acuity of 20/100 or better.\n\nExclusion Criteria:\n\n* Uncontrolled medical conditions.\n* Subjects who wear contact lenses.\n* Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.\n* Subjects who have a history of chronic or recurrent inflammatory eye disease.'}, 'identificationModule': {'nctId': 'NCT00650702', 'acronym': 'CORE', 'briefTitle': 'Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mati Therapeutics Inc.'}, 'officialTitle': 'A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'PPL GLAU 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Low Latanoprost-PPDS', 'interventionNames': ['Drug: Latanoprost-PPDS']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Medium Latanoprost-PPDS', 'interventionNames': ['Drug: Latanoprost-PPDS']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'High Latanoprost-PPDS', 'interventionNames': ['Drug: Latanoprost-PPDS']}], 'interventions': [{'name': 'Latanoprost-PPDS', 'type': 'DRUG', 'description': 'Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy', 'armGroupLabels': ['1']}, {'name': 'Latanoprost-PPDS', 'type': 'DRUG', 'description': 'Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy', 'armGroupLabels': ['2']}, {'name': 'Latanoprost-PPDS', 'type': 'DRUG', 'description': 'Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '21014', 'city': 'Bel Air', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.53594, 'lon': -76.34829}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11563', 'city': 'Lynbrook', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.65483, 'lon': -73.6718}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '19148', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mati Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}