Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT00399061
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2006-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Optive Versus Systane 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-23', 'studyFirstSubmitDate': '2006-11-09', 'studyFirstSubmitQcDate': '2006-11-09', 'lastUpdatePostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '1 yr 3 months'}], 'secondaryOutcomes': [{'measure': 'Dry eye symptoms', 'timeFrame': '1yr 3 months'}]}, 'conditionsModule': {'conditions': ['Dry Eye']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.'}, '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 * Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients)\n * At least Grade 2 conjunctival staining\n * Likely to complete all study visits and able to provide informed consent\n\nExclusion Criteria:\n\n* · Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)\n\n * Current use of topical cyclosporine\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 * Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization)\n * Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)\n * Ocular surgery within the past 3 months,\n * Active ocular allergies'}, 'identificationModule': {'nctId': 'NCT00399061', 'briefTitle': 'Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovative Medical'}, 'officialTitle': 'Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms', 'orgStudyIdInfo': {'id': '5278'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Systane', 'interventionNames': ['Drug: Systane, Optive, Restasis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Optive', 'interventionNames': ['Drug: Systane, Optive, Restasis']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Restasis', 'interventionNames': ['Drug: Systane, Optive, Restasis']}], 'interventions': [{'name': 'Systane, Optive, Restasis', 'type': 'DRUG', 'description': 'Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12159', 'city': 'Slingerlands', 'state': 'New York', 'country': 'United States', 'facility': 'Dr. Schultze', 'geoPoint': {'lat': 42.62925, 'lon': -73.86457}}], 'overallOfficials': [{'name': 'Robert Schultze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Slingerlands Medical Building'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovative Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Robert Schultze, MD', 'oldOrganization': 'Slingerlands Medical Building'}}}}