Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT00821002
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2009-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'dispFirstSubmitDate': '2011-03-01', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2009-01-08', 'dispFirstSubmitQcDate': '2011-03-01', 'studyFirstSubmitQcDate': '2009-01-09', 'dispFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure change from baseline (mmHg)', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with adverse events', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma'], 'conditions': ['Open-Angle Glaucoma', 'Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'The study objective is to compare IOP and safety outcomes based on plug placement (upper or lower puncta).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years\n* Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension\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'}, 'identificationModule': {'nctId': 'NCT00821002', 'briefTitle': 'A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mati Therapeutics Inc.'}, 'officialTitle': 'An Open-Label, Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)', 'orgStudyIdInfo': {'id': 'PPL GLAU 05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plug placement', 'interventionNames': ['Drug: Latanoprost']}], 'interventions': [{'name': 'Latanoprost', 'type': 'DRUG', 'description': 'Comparison of punctal plug placement between upper and lower puncta', 'armGroupLabels': ['Plug placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94025', 'city': 'Menlo Park', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.45383, 'lon': -122.18219}}], 'overallOfficials': [{'name': 'Oscar Cuzanni, MD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'QLT Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mati Therapeutics Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'QLT Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}