Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-29 @ 11:37 PM
Study NCT ID:
NCT01102257
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2010-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dry Eye Assessment and Management: Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'penny.asbell@mssm.edu', 'phone': '(212) 241-7977', 'title': 'Dr. Penny Asbell', 'organization': 'Mount Sinai School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'DREAM: Feasibility Study, is labeled "feasibility" because its primary end-point is to demonstrate an ability to execute the protocol rather than generate statistically relevant data on the safety and efficacy of omega-3 EFA in patients with DED.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Omega-3 Supplement', 'description': '5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Olive Oil', 'description': '5 Gel Capsules of olive oil taken orally daily', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 9, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'watery eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adnexal mass due to graft verus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change on Ocular Surface Disease Index (OSDI)', 'timeFrame': '90 +/- 14 days following initiation of drug regimen', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change on Brief Ocular Discomfort Inventory (BODI)', 'timeFrame': '90 +/- 14 days following initiation of drug regimen', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change on Impact of Dry Eye on Everyday Life (IDEEL)', 'timeFrame': '90 +/- 14 days following initiation of drug regimen', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life Associated With Chronic Pain', 'timeFrame': '90 +/- 14 days following initiation of drug regimen', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Ocular Surface', 'timeFrame': '90 +/- 14 days following initiation of drug regimen', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': "Change in Schirmer's", 'timeFrame': '90 +/- 14 days following initiation of drug regimen', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines', 'timeFrame': '90 +/- 14 days following initiation of drug regimen', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3 Supplement', 'description': '5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA'}, {'id': 'OG001', 'title': 'Olive Oil', 'description': '5 Gel Capsules of olive oil taken orally daily'}], 'classes': [{'title': 'eicosapentaenoic acid(EPA)', 'categories': [{'measurements': [{'value': '1.46', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '2.39'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0.09'}]}]}, {'title': 'docosahexaenoic acid(DHA)', 'categories': [{'measurements': [{'value': '1.49', 'groupId': 'OG000', 'lowerLimit': '-0.36', 'upperLimit': '1.90'}, {'value': '0.25', 'groupId': 'OG001', 'lowerLimit': '-0.20', 'upperLimit': '0.36'}]}]}, {'title': 'Arachdinocic acid(AA)', 'categories': [{'measurements': [{'value': '-1.91', 'groupId': 'OG000', 'lowerLimit': '-3.17', 'upperLimit': '-0.97'}, {'value': '-0.23', 'groupId': 'OG001', 'lowerLimit': '-0.84', 'upperLimit': '-0.05'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 3 Months', 'unitOfMeasure': 'Percentage Total Fatty Acids', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omega-3 Supplement', 'description': '5 Gel Capsules to be taken orally daily to give a total dose of 2000mg EPA and 1000 mg DHA'}, {'id': 'FG001', 'title': 'Olive Oil', 'description': '5 Gel Capsules of olive oil to be taken orally daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2 withdrew from the study d/t adverse events. 1 had shortness of breath and the other had chest pain', 'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omega-3 Supplement', 'description': '5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA'}, {'id': 'BG001', 'title': 'Olive Oil', 'description': '5 Gel Capsules of olive oil taken orally daily'}, {'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': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '14', 'groupId': 'BG000'}, {'value': '57', 'spread': '15', 'groupId': 'BG001'}, {'value': '56', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-20', 'studyFirstSubmitDate': '2010-04-09', 'resultsFirstSubmitDate': '2011-04-29', 'studyFirstSubmitQcDate': '2010-04-09', 'lastUpdatePostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-20', 'studyFirstPostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on Ocular Surface Disease Index (OSDI)', 'timeFrame': '90 +/- 14 days following initiation of drug regimen'}, {'measure': 'Change in REd Blood Cell(RBC) Membrane Fatty Acid(FA) Content', 'timeFrame': 'Baseline and 3 Months'}], 'secondaryOutcomes': [{'measure': 'Change on Brief Ocular Discomfort Inventory (BODI)', 'timeFrame': '90 +/- 14 days following initiation of drug regimen'}, {'measure': 'Change on Impact of Dry Eye on Everyday Life (IDEEL)', 'timeFrame': '90 +/- 14 days following initiation of drug regimen'}, {'measure': 'Change in Quality of Life Associated With Chronic Pain', 'timeFrame': '90 +/- 14 days following initiation of drug regimen'}, {'measure': 'Change in the Ocular Surface', 'timeFrame': '90 +/- 14 days following initiation of drug regimen'}, {'measure': "Change in Schirmer's", 'timeFrame': '90 +/- 14 days following initiation of drug regimen'}, {'measure': 'Change in Relevant Biomarkers: HLA-DR, MUC 5A, Cytokines', 'timeFrame': '90 +/- 14 days following initiation of drug regimen'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dry Eye Disease', 'DED', 'Keratoconjunctivitis Sicca', 'Omega-3'], 'conditions': ['Dry Eye Syndromes', 'Keratoconjunctivitis Sicca']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test a protocol investigating the efficacy of omega-3 fatty acids in treating dry eye disease. The study is termed "feasibility" because its purpose is to demonstrate an ability to execute the proposed protocol with compliance at two sites rather than generate statistically relevant data concerning the safety and efficacy of the supplement in patients with dry eye disease.', 'detailedDescription': 'Dry eye disease (DED) is a common but often inadequately treated disease of the tears and surface of the eye. It can cause poor vision and chronic pain and is more frequent with increasing age. Inflammation may be an important component of this disease. This is supported by the observation that cyclosporine, a drug that targets the immune system, is approved for and effectively treats DED. Inflammatory processes likely produce ocular surface damage and contribute to chronic DED. Because not all people with DED respond to current anti-inflammatory treatments, other immune-modulating treatments would be of value. Furthermore, despite a great deal of evidence supporting DED as an inflammatory disease, not all researchers currently agree with this classification. More data that specifically measures inflammatory responses in DED needs to be collected in a well-characterized patient population and correlated with signs and symptoms of DED in order to improve our understanding and classification of the disease.\n\nEssential Fatty Acids (EFA) have been shown to diminish inflammatory responses in many human inflammatory diseases, and interest in the use of omega-3 and omega-6 fatty acids for disease treatment has resulted in several small studies as well as the use (and over-the-counter availability) of EFA-containing nutritional supplements, including several specifically for the treatment of DED. Despite this interest in EFA for DED, there are no strong empirical data from a well-controlled randomized controlled trial RCT supporting the use of EFA for DED. We postulate that DED is an inflammatory disease and hypothesize that EFA can mediate immune responses, thus improving DED signs, symptoms and associated measures of inflammation. The proposed three month feasibility study allows us the chance to demonstrate our ability to successfully execute our own protocol with compliance from the study patients before we begin the process of initiating a full-scale multi-center trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Sign and date the informed consent form approved by the IRB.\n2. ≥ 18 years of age\n3. Demonstrate at least 2 of the 4 following signs in the same eye at two consecutive visits (Visit 1: 7 - 21 days prior to randomization, and Visit 2: day of randomization).\n\n 1. Conjunctival staining present ≥ 1\n 2. Corneal fluorescein staining present ≥ 1\n 3. Tear film break up time (TFBUT) ≤ 7 seconds\n 4. Schirmer test ≤ 7 mm/5min\n4. Demonstrate symptoms of dry eye disease (OSDI score of at least 22 at screening visit and at least 15 at randomization visit).\n5. Use or desire to use artificial tears on average of 2 times per day in the 2 weeks preceding study entry (run in period). No newly diagnosed patients can be enrolled and if a new patient wants to participate, she/he must be put on tears and re-evaluated in 6 months.\n6. Intraocular pressure (IOP) ≥ 5 mmHg and ≤ 22 mmHg in each eye.\n7. Women of child-bearing potential must agree to use a reliable method of contraception during study participation, and must demonstrate a negative urine pregnancy test at screening visit.\n8. Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff.\n9. Be able to swallow large, soft gelcaps\n\nExclusion Criteria:\n\n1. Patients who are allergic to ingredients of the active or placebo pills (fish, olive oil).\n2. Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).\n3. History of ocular herpetic keratitis.\n4. Eye surgery (including cataract surgery) within 6 months prior to randomization.\n5. Previous LASIK surgery\n6. Pregnant or nursing/lactating\n7. Participation in a study of an investigational drug or device within the past 30 days.\n8. Recent (≤ 3 months) initiation of use of systemic corticosteroids or other immunosuppressive agent and/or is planning to change treatment during study participation\n9. Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.\n10. Contact lens wearers\n11. Use of glaucoma medication or history of surgery for glaucoma.\n12. Recent (≤ 3 months) insertion of punctual plugs.\n13. Using punctual plugs but unwilling to commit to their use for the duration of the study.\n14. Unwilling to commit to same brand of artificial tears throughout the study.\n15. Current use of EPA/DHA supplements in excess of 1 gram/day.\n16. Recent (≤ 6 months) initiation of use of Restasis.\n17. Use of Restasis but unwilling to commit to use of Restasis for the duration of the study.\n18. Discontinued use of Restasis within the last 3 months.'}, 'identificationModule': {'nctId': 'NCT01102257', 'acronym': 'DREAM', 'briefTitle': 'Dry Eye Assessment and Management: Feasibility Study', 'organization': {'class': 'INDIV', 'fullName': 'Asbell, Penny, M.D.'}, 'officialTitle': 'Clinical Trial of Essential Fatty Acids for Dry Eye Disease: Feasibility Study', 'orgStudyIdInfo': {'id': '05-1099'}, 'secondaryIdInfos': [{'id': '1R34EY017626', 'link': 'https://reporter.nih.gov/quickSearch/1R34EY017626', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega-3 EFA Supplement', 'description': 'The total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 esssential fatty acid i.e Omega-3 EFA supplement comprised of:\n\n2000 mg EPA 1000 mg DHA', 'interventionNames': ['Drug: Omega-3 EFA Supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Olive Oil', 'description': 'Gel Capsule', 'interventionNames': ['Drug: Olive Oil']}], 'interventions': [{'name': 'Omega-3 EFA Supplement', 'type': 'DRUG', 'otherNames': ['Fish oil supplements'], 'description': 'The total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 EFAs comprised of:\n\n2000 mg EPA 1000 mg DHA', 'armGroupLabels': ['Omega-3 EFA Supplement']}, {'name': 'Olive Oil', 'type': 'DRUG', 'description': 'Placebo group will take 5 capsules a day containing 3.0 grams of olive oil', 'armGroupLabels': ['Olive Oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Penny Asbell, • MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asbell, Penny, M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Penny Asbell', 'investigatorAffiliation': 'Asbell, Penny, M.D.'}}}}