Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT01269658
Status:
TERMINATED
Last Update Posted:
2013-11-21
First Post:
2010-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001762', 'term': 'Blepharitis'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'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': 40}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'dispFirstSubmitDate': '2011-07-06', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-29', 'studyFirstSubmitDate': '2010-12-21', 'dispFirstSubmitQcDate': '2011-07-06', 'studyFirstSubmitQcDate': '2011-01-03', 'dispFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of clinical signs of blepharitis', 'timeFrame': 'Day 28'}], 'secondaryOutcomes': [{'measure': 'Time to first clinical resolution', 'timeFrame': 'Days 7, 14, 21, 28, 42, 56, 70, and 84'}, {'measure': 'Mean and change from baseline for clinical signs of blepharitis', 'timeFrame': 'Days 7, 14, 21, 28, 42, 56, 70, and 84'}, {'measure': 'Mean and change from end of dosing for clinical signs of blepharitis', 'timeFrame': 'Days 42, 56, 70, and 84'}, {'measure': 'Response to the Blepharitis Symptoms Questionnaire (BSQ)', 'timeFrame': 'Days 1, 7, 14, 21, 28, 42, 56, 70, and 84'}]}, 'conditionsModule': {'conditions': ['Blepharitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% versus vehicle over a four-week treatment period in treating the signs and symptoms of subjects with blepharitis and to evaluate the clinical course of the condition under study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a current diagnosis of blepharitis\n* Have a best corrected visual acuity (BCVA), using corrective lenses if\n\nnecessary, in both eyes of at least +0.7\n\n* If female, are non-pregnant or non-lactating\n\nExclusion Criteria:\n\n* Have a concurrent acute hordeolum (stye) or chalazion\n* Have inflammation of the ocular surface\n* Have used artificial tears within 48 hours prior to Visit 1 or anticipate\n\nusing during the study\n\n* Have had ocular surgery in the past 90 days or will require it during the\n\nstudy\n\n* Unable to withhold the use of contact lenses during the study\n* Have a known hypersensitivity to azithromycin, erythromycin, any other\n\nmacrolide antibiotic, or any of the other ingredients in the study\n\nmedication\n\n* Have been diagnosed with ongoing glaucoma\n* Unable to withhold the use of ocular cosmetic products within 48 hours\n\nprior to Visit 1 and throughout the study\n\n* Have a serious medical condition which could confound study assessments'}, 'identificationModule': {'nctId': 'NCT01269658', 'briefTitle': 'A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled, Parallel-Group, Safety and Efficacy Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle for Four Weeks in Subjects With Blepharitis', 'orgStudyIdInfo': {'id': 'P08636'}, 'secondaryIdInfos': [{'id': 'P08636'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azithromycin ophthalmic solution, 1%', 'interventionNames': ['Drug: Azithromycin ophthalmic solution, 1%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'Azithromycin ophthalmic solution, 1%', 'type': 'DRUG', 'description': '1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)', 'armGroupLabels': ['Azithromycin ophthalmic solution, 1%']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': '1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Charles Johnson, MBChB', 'role': 'STUDY_CHAIR', 'affiliation': 'Chief Medical Officer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}