Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-19 @ 5:41 AM
Study NCT ID:
NCT00348335
Status:
COMPLETED
Last Update Posted:
2011-07-29
First Post:
2006-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Topical Cyclosporin for Ocular Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-28', 'studyFirstSubmitDate': '2006-06-30', 'studyFirstSubmitQcDate': '2006-06-30', 'lastUpdatePostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hyperemia', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rosacea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective in the treatment of ocular rosacea', 'detailedDescription': 'The study is designed to compare the efficacy of topical cyclosporin (Restasis) with that of Refresh Endura for the treatment of the signs and symptoms of ocular rosacea in patients presently controlled on topical corticosteroids'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient at least 18 years old, but younger than 65\n* Diagnosis of acne rosacea\n* Active ocular rosacea based on lid findings of meibomian gland dysfunction with lid telangiectasia and hyperemia of at least 2+\n* Schirmers test of greater than 5mm in at least 1 eye\n* If patient currently using lid hygiene must maintain regimen during study\n* Stop oral antibiotics at least 4 weeks prior\n\nExclusion Criteria:\n\n* Use of topical cyclosporin within last 90 days\n* Visual acuity of 20/100 or better in both eyes\n* Pregnant or lactating females\n* Active ocular infection\n* Scarring of central cornea\n* Eyelid defects,abnormal lid positioning or lagophthalmos\n* Flax seed or Fish oil supplements within last 30 days'}, 'identificationModule': {'nctId': 'NCT00348335', 'briefTitle': 'Efficacy of Topical Cyclosporin for Ocular Rosacea', 'organization': {'class': 'OTHER', 'fullName': 'Ophthalmic Consultants of Long Island'}, 'officialTitle': 'Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea', 'orgStudyIdInfo': {'id': '32,133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1: Restasis', 'interventionNames': ['Drug: Cyclosporine 0.05%']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2: Refresh Endura', 'interventionNames': ['Drug: Ocular lubricant']}], 'interventions': [{'name': 'Cyclosporine 0.05%', 'type': 'DRUG', 'armGroupLabels': ['1: Restasis']}, {'name': 'Ocular lubricant', 'type': 'DRUG', 'armGroupLabels': ['2: Refresh Endura']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': '2500 Rte 347 Bldg 24', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}], 'overallOfficials': [{'name': 'John R Wittpenn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Consultants of Long Island'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ophthalmic Consultants of Long Island', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. Eric Donnenfeld', 'oldOrganization': 'OCLI'}}}}