Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-30 @ 11:38 PM
Study NCT ID:
NCT00643669
Status:
COMPLETED
Last Update Posted:
2012-11-29
First Post:
2008-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
24 Hour IOP Lowering Efficacy of AL-3789
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'dispFirstSubmitDate': '2012-11-27', 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2008-03-24', 'dispFirstSubmitQcDate': '2012-11-27', 'studyFirstSubmitQcDate': '2008-03-24', 'dispFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Intraocular Pressure (IOP)', 'timeFrame': 'Day 28, Up to 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Open-angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to describe the intraocular pressure-lowering efficacy of AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP was measured every 4 hours, beginning at 8 AM for 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of open-angle glaucoma and treated for at least 30 days prior to Screening Visit with a topical prostaglandin analog as monotherapy.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Pregnant, intend to become pregnant, breastfeeding.\n* Difference in IOP greater than 3 mm Hg between eyes at Screening Visit.\n* Any form of glaucoma other than open-angle glaucoma.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00643669', 'briefTitle': '24 Hour IOP Lowering Efficacy of AL-3789', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-07-65'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AL-3789', 'description': 'AL-3789 Sterile Suspension, single depot administration of 0.8 mL in the study eye', 'interventionNames': ['Drug: AL-3789 Sterile Suspension']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'Fellow eye, as randomized'}], 'interventions': [{'name': 'AL-3789 Sterile Suspension', 'type': 'DRUG', 'description': 'Single administration by anterior juxtascleral depot', 'armGroupLabels': ['AL-3789']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Inglewood', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}