Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-27 @ 9:00 AM
Study NCT ID:
NCT01695668
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2012-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069559', 'term': 'Loteprednol Etabonate'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'smian@med.umich.edu', 'phone': '734-647-8397', 'title': 'Dr Shahzad Mian', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lotemax', 'description': 'Loteprednol Etabonate 0.5%\n\nLotemax', 'otherNumAtRisk': 38, 'otherNumAffected': 15, 'seriousNumAtRisk': 38, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Restasis', 'description': 'Cyclosporine\n\nRestasis', 'otherNumAtRisk': 37, 'otherNumAffected': 12, 'seriousNumAtRisk': 37, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'severe Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Eye disorders'}], 'seriousEvents': [{'term': 'death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression of Dry Eye Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lotemax', 'description': 'Loteprednol Etabonate 0.5%'}, {'id': 'OG001', 'title': 'Restasis', 'description': 'Cyclosporine'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions.', 'unitOfMeasure': 'patients with increased dry eye severity', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lotemax', 'description': 'Loteprednol Etabonate 0.5%'}, {'id': 'FG001', 'title': 'Restasis', 'description': 'Cyclosporine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lotemax', 'description': 'Loteprednol Etabonate 0.5%'}, {'id': 'BG001', 'title': 'Restasis', 'description': 'Cyclosporine'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.06', 'spread': '13.68', 'groupId': 'BG000'}, {'value': '51.21', 'spread': '14.44', 'groupId': 'BG001'}, {'value': '52.64', 'spread': '14.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2012-09-25', 'resultsFirstSubmitDate': '2015-01-16', 'studyFirstSubmitQcDate': '2012-09-27', 'lastUpdatePostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-24', 'studyFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of Dry Eye Severity', 'timeFrame': '1 year', 'description': 'Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Graft versus Host Disease (GVHD)', 'dry eyes', 'Bone marrow transplant (BMT)', 'Restasis', 'Lotemax'], 'conditions': ['Dry Eyes']}, 'descriptionModule': {'briefSummary': "The purpose of this research is to:\n\n1. Evaluate the safety and efficacy of a steroid eye drop (Lotemax) in patients who have been diagnosed with graft-versus-host disease (GVHD), which is a complication that may occur after bone marrow transplant where the newly transplanted material attacks the patient's body and may cause eye dryness.\n2. Assess the safety and efficacy of Lotemax in decreasing the eye's reaction to the process in GVHD before the patient undergoes bone marrow transplant.\n3. Compare how well Lotemax works in decreasing the process in GVHD with an immunosuppressive eye drop (Restasis), which has been commonly used in the treatment of this condition.", 'detailedDescription': "Allogeneic bone marrow or peripheral stem cell transplantation result in Graft-versus-Host disease. Ocular symptoms may be the first presentation of GVHD and may be seen in the absence of systemic manifestations. GVHD is categorized into acute and chronic forms as defined by 100 days after the transplant. Acute GVHD is characterized by dermatitis, hepatitis, and enteritis. Chronic GVHD involves the skin, mouth, liver, gastrointestinal tract, lungs, and eyes. Ocular GVHD is a common cause of dry eye symptoms in patients who have undergone bone marrow transplant (BMT), and can be defined as ocular surface disease in the context of GVHD. Dry eyes develop in 76% of acute GVHD patients and between 62.5% and 81.8% of chronic GVHD patients. Current treatment for ocular GVHD includes topical cyclosporine 0.05% (Restasis, Allergan). Topical loteprednol etabonate 0.5% (Lotemax, Bausch and Lomb) has been shown to be safe and efficacious in treatment of inflammatory ocular disorders, but has not been prospectively studied in ocular GVHD.\n\n2\\. Hypothesis: We anticipate that topical loteprednol etabonate 0.5% will be safe and efficacious in treatment of ocular GVHD patients, and would add to the armamentarium of therapeutics for this disease. Further, by following the natural progression of the disease prior to a patient's Bone Marrow Transplant (BMT), we may elucidate a new standard of care for these patients - one that involves referral to an ophthalmologist before ocular GVHD symptoms arise."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nScheduled for allogenic bone marrow transplant\n\nExclusion Criteria:\n\nAllergic reaction to loteprednol or cyclosporine, previous allogenic transplant'}, 'identificationModule': {'nctId': 'NCT01695668', 'acronym': 'Lotemax_BMT', 'briefTitle': 'Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol', 'orgStudyIdInfo': {'id': 'Lotemax_00045815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lotemax', 'description': 'Loteprednol Etabonate 0.5%', 'interventionNames': ['Drug: Lotemax']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restasis', 'description': 'Cyclosporine', 'interventionNames': ['Drug: Restasis']}], 'interventions': [{'name': 'Lotemax', 'type': 'DRUG', 'otherNames': ['Loteprednol'], 'description': 'Ophthalmic corticosteroid. It decreases inflammation of the eye', 'armGroupLabels': ['Lotemax']}, {'name': 'Restasis', 'type': 'DRUG', 'otherNames': ['cyclosporine'], 'description': 'Restasis is an immunosuppressive agent. Cyclosporine may reduce inflammation in the eye.', 'armGroupLabels': ['Restasis']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shahzad Mian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Terry J. Bergstrom Professor for Resident Education, Associate Professor, Cornea and External Disease', 'investigatorFullName': 'Shahzad Mian', 'investigatorAffiliation': 'University of Michigan'}}}}