Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-05 @ 5:12 PM
Study NCT ID:
NCT00405457
Status:
COMPLETED
Last Update Posted:
2010-02-22
First Post:
2006-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003524', 'term': 'Cyclosporins'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-19', 'studyFirstSubmitDate': '2006-11-28', 'studyFirstSubmitQcDate': '2006-11-28', 'lastUpdatePostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy', 'timeFrame': '1 yr 3 months'}], 'secondaryOutcomes': [{'measure': 'dry eye symptoms', 'timeFrame': '1 yr 3 months'}]}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* · Males or females \\> 18 years old\n\n * Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.\n * Likely to complete all study visits and able to provide informed consent\n\nExclusion Criteria:\n\n* · Patients using Restasis® for less than 3 months.\n\n * Known contraindications to any study medication or ingredients\n * Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.\n * Other active uncontrolled ocular diseases or uncontrolled systemic disease'}, 'identificationModule': {'nctId': 'NCT00405457', 'briefTitle': 'Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovative Medical'}, 'officialTitle': 'Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms', 'orgStudyIdInfo': {'id': '5261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'interventionNames': ['Drug: Restasis, Optive Tears']}], 'interventions': [{'name': 'Restasis, Optive Tears', 'type': 'DRUG', 'description': 'Restasis and Optive Tears use twice daily more frequently if needed', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Eye Consultants', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'David Hardten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minnesota Eye Consultants'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovative Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'David Hardten, MD', 'oldOrganization': 'Minnesota Eye Consultants'}}}}