Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-30 @ 7:08 AM
Study NCT ID:
NCT01379560
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2011-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Ocular Blood Flow Effects of Unoprostone Isopropyl in Adults With Dry Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C072630', 'term': 'isopropyl unoprostone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-06', 'studyFirstSubmitDate': '2011-06-21', 'studyFirstSubmitQcDate': '2011-06-21', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in choroidal blood flow', 'timeFrame': 'In total 6 hours'}]}, 'conditionsModule': {'conditions': ['Dry Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the pharmacodynamics of ocular blood flow measurements with multiple drop unoprostone isopropyl administration versus placebo in subjects with dry age-related macular degeneration (AMD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 50 years at screening\n* Ametropy ≤ 3 diopters\n* Clear ocular media\n* Visual acuity in the study eye \\> 20/40\n\nExclusion Criteria:\n\n* Presence of any ocular condition in the study eye (other than AMD) that may progress during the course of the study and could affect central vision, or other ocular conditions that may be a confounding factor in this study\n* Blood donation during the previous 3 weeks\n* Current smoker or a history of smoking within 5 years of enrollment\n* Treatment with protocol-specified prohibited concomitant medications\n* Prior exposure to Rescula (unoprostone isopropyl) and or a known sensitivity to any of the components of the study medication (e.g. benzalkonium chloride)'}, 'identificationModule': {'nctId': 'NCT01379560', 'briefTitle': 'A Study to Evaluate the Ocular Blood Flow Effects of Unoprostone Isopropyl in Adults With Dry Age-related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'orgStudyIdInfo': {'id': 'SPA/UIOS-AMD-1021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'unoprostone isopropyl (2 drop)', 'interventionNames': ['Drug: unoprostone isopropyl']}, {'type': 'EXPERIMENTAL', 'label': 'unoprostone isopropyl (3 drop)', 'interventionNames': ['Drug: unoprostone isopropyl']}], 'interventions': [{'name': 'unoprostone isopropyl', 'type': 'DRUG', 'description': '1. unoprostone isopropyl (2 drops)\n2. placebo (2 drops)', 'armGroupLabels': ['unoprostone isopropyl (2 drop)']}, {'name': 'unoprostone isopropyl', 'type': 'DRUG', 'description': '1. unoprostone isopropyl (3 drops)\n2. placebo (3 drops)', 'armGroupLabels': ['unoprostone isopropyl (3 drop)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sucampo Pharma Americas, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sucampo Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}