Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-09 @ 12:08 PM
Study NCT ID:
NCT03686059
Status:
COMPLETED
Last Update Posted:
2019-11-26
First Post:
2018-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Omega 3 FA and Punctal Plugs on Ocular Surface Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D000070635', 'term': 'Punctal Plugs'}], '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'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-24', 'studyFirstSubmitDate': '2018-09-25', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Break up Time at baseline and during the study', 'timeFrame': '3 months', 'description': 'fluorescein sodium stripes will be used for measurement of Break up Time in seconds'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ocular Surface Disease']}, 'descriptionModule': {'briefSummary': 'Ocular surface disease is a common adverse effect of systemic isotretinoin therapy.\n\nThe investigators consider that punctal plugs and Omega 3 is a good line for treatment of ocular surface disease associated with systemic isotretinoin therapy', 'detailedDescription': 'Subjective and objective evaluation of ocular surface disease was done at baseline ,1 and 3 months of the study .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* systemic isotretinoin therapy\n\nExclusion Criteria:\n\n* systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearer'}, 'identificationModule': {'nctId': 'NCT03686059', 'briefTitle': 'Outcome of Omega 3 FA and Punctal Plugs on Ocular Surface Disease', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Outcome of Concomitant Use of Punctal Plugs and Omeg 3 Fatty Acids on Ocular Surface Disease in Patients Using Systemic Isotretinoin', 'orgStudyIdInfo': {'id': 'hamaky1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'punctal plug', 'description': 'SOFT PLUG® Preloaded Silicone Plugs by OASIS®', 'interventionNames': ['Device: punctal plug']}, {'type': 'EXPERIMENTAL', 'label': 'Combined', 'description': 'SOFT PLUG® Preloaded Silicone Plugs by OASIS® plus Daily intake of DHA (docosahexaenoic acid)', 'interventionNames': ['Drug: Omega 3', 'Device: punctal plug']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'no medication was given'}], 'interventions': [{'name': 'Omega 3', 'type': 'DRUG', 'otherNames': ['docosahexaenoic acid'], 'description': 'daily intake of 250 mg', 'armGroupLabels': ['Combined']}, {'name': 'punctal plug', 'type': 'DEVICE', 'otherNames': ['OASIS SOFT PLUG'], 'description': 'punctal plug will be inserted in inferior punctum', 'armGroupLabels': ['Combined', 'punctal plug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37496', 'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'facility': 'ACDS', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of ophthalmology', 'investigatorFullName': 'Tarek Roshdy mohamed Mahgoub ELhamaky', 'investigatorAffiliation': 'Benha University'}}}}