Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT01220258
Status:
TERMINATED
Last Update Posted:
2013-12-16
First Post:
2010-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-13', 'studyFirstSubmitDate': '2010-10-12', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline of investigator-rated scores for eyelid margin erythema', 'timeFrame': 'Week 4'}], 'secondaryOutcomes': [{'measure': 'Change from baseline of investigator-rated scores of blepharoconjunctivitis signs', 'timeFrame': 'Weeks 2, 4, 6, 8'}, {'measure': 'Change from baseline of subject-rated scores of blepharoconjunctivitis symptoms', 'timeFrame': 'Weeks 2, 4, 6, 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Posterior Blepharoconjunctivitis']}, 'descriptionModule': {'briefSummary': 'One objective of this study is to determine the levels of markers of inflammation on the eyelid margin of subjects with blepharoconjunctivitis and compare them with those of healthy volunteers. Another objective is to determine in subjects with blepharoconjunctivitis the effect of azithromycin ophthalmic solution, 1 % on markers of inflammation of lid margins and conjunctivae and on signs and symptoms of blepharoconjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a current diagnosis of posterior blepharoconjunctivitis in both eyes\n\n(except for healthy volunteers)\n\n* Have a Best Corrected Visual Acuity (BCVA), using corrective lenses if necessary, in both eyes of at least +0.7 LogMAR\n* If female, are non-pregnant or non-lactating\n\nExclusion Criteria:\n\n* Have anterior blepharitis\n* Have lid structural abnormalities\n* Have had penetrating intraocular surgery in the past 90 days or require\n\npenetrating intraocular surgery during the study\n\n* Unable to withhold the use of contact lenses within 3 days prior to Visit 1\n\nduring the study\n\n* Have been diagnosed with ongoing glaucoma\n* Have a serious medical condition which could confound study assessments'}, 'identificationModule': {'nctId': 'NCT01220258', 'briefTitle': 'A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single-Center, Open-Label Study to Characterize Eyelid Margin Erythema, Markers of Clinical Inflammation and Levels of Inflammatory Mediators in the Lid Margins and Conjunctivae of Untreated Healthy Volunteers and Subjects Diagnosed With Posterior Blepharoconjunctivitis Following Dosing With Azithromycin Ophthalmic Solution, 1% for Four Weeks', 'orgStudyIdInfo': {'id': 'P08641'}, 'secondaryIdInfos': [{'id': '041-118'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azithromycin ophthalmic solution, 1%', 'interventionNames': ['Drug: Azithromycin ophthalmic solution, 1%']}], '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%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Eye Clinic, Alkek Eye Center of Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Reza Haque, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Monitor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}