Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-04-15 @ 8:50 PM
Study NCT ID:
NCT01481051
Status:
COMPLETED
Last Update Posted:
2013-09-26
First Post:
2011-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'dispFirstSubmitDate': '2013-09-16', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2011-11-25', 'dispFirstSubmitQcDate': '2013-09-16', 'studyFirstSubmitQcDate': '2011-11-25', 'dispFirstPostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP change from baseline', 'timeFrame': '12 weeks to baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma', 'Ocular Hypertension (OH)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female at least 18 years old\n* Diagnosis of bilateral open angle glaucoma or ocular hypertension\n* Unmedicated IOP must be ≥22mm Hg\n\nExclusion Criteria:\n\n* Any significant vision loss in the last year\n* No contact lens use for the length of the study\n* Abnormal eye lids, eye infection, or diseases to the eye\n* Recent eye surgery\n* Uncontrolled medication conditions'}, 'identificationModule': {'nctId': 'NCT01481051', 'briefTitle': 'A Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mati Therapeutics Inc.'}, 'officialTitle': 'PPL GLAU 12: A Phase 2 Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)', 'orgStudyIdInfo': {'id': 'PPL GLAU 12'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Latanoprost-PPDS', 'type': 'DRUG', 'description': 'Sustained delivery for 12 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'facility': 'Sall Research Medical Center, Inc', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '90505', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Wolstan & Goldberg Eye Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92115', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Eye Care Associates', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Coastal Research Associates, LLC', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'R and R Eye Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Rocky Mountain Eye Care Associates', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Suzanne Cadden', 'role': 'STUDY_DIRECTOR', 'affiliation': 'QLT Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mati Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}