Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-03-01 @ 6:11 AM
Study NCT ID:
NCT02260960
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2014-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease
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': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2014-10-06', 'studyFirstSubmitQcDate': '2014-10-08', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tear Osmolarity', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity, Schirmer-1 test values, corneal staining, and fluorescein tear break-up time) when compared to administration of placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 and ≤ 90 at the time of informed consent\n* Subjects experiencing dry eye based on a global clinical assessment by the attending clinician, subject complaint of dry eye symptoms\n* Presence or History of Tear Osmolarity (Appendix 2) equal to or greater than 312 mOsm/L in at least one eye\n* Presence or History of Meibomian Gland Dysfunction (Grade 1 or 2) in at least one eye\n\nExclusion Criteria:\n\n* Allergy to fish oil or safflower oil\n* Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia\n* Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring Active ocular or nasal allergy\n* LASIK or PRK surgery that was performed within one year of the Screening Visit or at any time during the study\n* Ophthalmologic drop use within 2 hours of any study visits. Any OTC habitual artificial tear should be continued at the same frequency and no change in drop brand\n* Contact lens wear within 12 hours of any study visits\n* Pregnancy or lactation during the study\n* Abnormal nasolacrimal drainage (by history)\n* Punctal cauterization or punctal plug placement within 60 days of screening\n* Prohibited Medications - Cyclosporine (Restasis®); any topical prescription medications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or topical macrolides; oral nutraceuticals (flax, black currant seed oils, etc…) within 3 weeks (21 days) of Screening and at any time during the study'}, 'identificationModule': {'nctId': 'NCT02260960', 'briefTitle': 'The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Physician Recommended Nutriceuticals'}, 'officialTitle': 'The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease.', 'orgStudyIdInfo': {'id': 'PRN 20142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega-3', 'description': 'Reesterified Triglyceride form omega 3', 'interventionNames': ['Dietary Supplement: Omega-3 (Triglyceride form)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'safflower oil', 'interventionNames': ['Dietary Supplement: Omega-3 (Triglyceride form)']}], 'interventions': [{'name': 'Omega-3 (Triglyceride form)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Omega-3', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Eye Center of Columbus', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Alice Epitropoulos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Eye Center of Columbus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Physician Recommended Nutriceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}