Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT01630551
Status:
WITHDRAWN
Last Update Posted:
2017-02-28
First Post:
2012-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Omega 3 Supplementation and Ocular Surface Disease in Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D022125', 'term': 'Lacerations'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Omega 3 fatty acid'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-24', 'studyFirstSubmitDate': '2012-05-31', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Surface Disease Index Score', 'timeFrame': '90 Days', 'description': 'Ocular surface disease validated questionnaire regarding ocular symptoms'}], 'secondaryOutcomes': [{'measure': 'Schirmer test score', 'timeFrame': '90 days', 'description': 'Scoring of tear production over 5 minutes'}, {'measure': 'Lissamine Green Staining Score', 'timeFrame': '90 Days', 'description': 'Ocular staining pattern for significant ocular surface disease'}, {'measure': 'Fluorescein tear break-up time', 'timeFrame': '90 Days', 'description': 'Clinical measure of tear film stability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tears', 'dry eyes', 'ocular surface disease'], 'conditions': ['Ocular Surface Disease']}, 'descriptionModule': {'briefSummary': 'Ocular surface disease (OSD) is a significant health problem that affects more than 10 million persons in the United States alone. OSD is highly prevalent among medically treated patients with glaucoma and is associated with the number of intraocular pressure (IOP)-lowering medications used.\n\nThe purpose of this study is to determine the potential effectiveness of anoritega-3 fatty acid nutritional supplement in the treatment of ocular surface disease associated"with the use of glaucoma eye drops', 'detailedDescription': "Description of procedures/methods:\n\nBASELINE VISIT Once the treating ophthalmologist has made the diagnosis of OSD, subjects will be asked to participate in the research study. Informed consent will be obtained for all subjects willing to participate in the study. Afterwards, the treating ophthalmologist will administer a dry eye questionnaire to each subject. After completion of the questionnaire, subjects will be given 90-day supply of the study drug/placebo. Based on a pre-determined randomization list, each subjects will be randomized to receive either the study medication (TheraTears nutritional supplementation) or a placebo drug (olive oil capsules). All subjects will be instructed to continue using artificial lubrication as needed while taking part in this study.\n\nWe hypothesize that therapy with an oral fish oil nutritional supplement containing 450mg EPA, 300 mg DHA, and 1000 mg flaxseed oil (TheraTears Nutrition; Advanced Vision Research, Woburn, MA) will decrease OSD-related symptoms as well as clinical markers associated with OSD (Schirmer test values, positive vital staining with lissamine green, fluorescein tear break-up time, and tear film osmolarity) when compared to administration of placebo.\n\nFOLLOW-UP VISIT Approximately 90 days after the baseline visit, subjects are scheduled to come to the clinic for their routine• eye check. At that visit, subject's O.SD will be re-assessed by the same examination techniques as the baseline visit. After the examination, the questionnaire will be administered for a second time. The study drug will be discontinued at that visit and standard therapy for the subject's OSO, as deemed necessary by the treating ophthalmologist, will be instituted.\n\nStatement of duration of subject participation:\n\nSubject will be in the study for 3 months. There will be two visits, one is the baseline and second is the follow-up visit. All visits will coincide with their regular clinic visit. The total hours of study participation is no more than 2 hours."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking)\n* OSDI score \\> 12\n* Schirmer Test with Anesthesia \\< 8 mm/5 minutes\n* Fluorescein tear break-up time \\< 8 seconds\n* No current use of dry eye treatment (except artificial lubrication)\n\nExclusion Criteria:\n\n* Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye or topical glaucoma medication use\n* Patients with severe tear deficiency (defined as Schirmer tes \\<5 mm/5 min)\n* Concomitant ocular pathology\n* History of ocular surgery\n* Eyelid or eyelash abnormalities\n* Alteration of the nasolacrimal apparatus\n* Treatment with drugs affecting tearing\n* Treatment with vitamin supplements\n* Concomitant ocular therapies\n* Topical ophthalmic steroids taken during the 4 weeks before the study\n* Pregnant/breast-feeding women\n* Women who may be pregnant at the baseline visit or may become pregnant during the 90 days of therapy\n* Diabetes\n* History of fish and/or shellfish allergy or hypersensitivity'}, 'identificationModule': {'nctId': 'NCT01630551', 'briefTitle': 'Omega 3 Supplementation and Ocular Surface Disease in Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Omega-3 Fatty Acid Nutritional Supplementation in the Treatment of Ocular Surface Disease Associated With Intraocular Pressure-Lowering Medications', 'orgStudyIdInfo': {'id': '2011-1136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fishoil nutritional supplement', 'description': '90 day supply of daily oral administration of a fish oil nutritional supplement (TheraTears Nutrition; Advanced Vision Research, Woburn, MA)', 'interventionNames': ['Dietary Supplement: Fishoil supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Olive oil capsules', 'description': '90 day supply of a daily dose of placebo olive oil capsules', 'interventionNames': ['Dietary Supplement: Olive Oil']}], 'interventions': [{'name': 'Fishoil supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 capsule per day', 'armGroupLabels': ['Fishoil nutritional supplement']}, {'name': 'Olive Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 capsule per day', 'armGroupLabels': ['Olive oil capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Glaucoma Service, Department of Ophthalmology and Visual Science', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Ahmad A Aref, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Glaucoma Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ahmad A. Aref, MD', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}