Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT03751059
Status:
UNKNOWN
Last Update Posted:
2020-10-19
First Post:
2018-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NSAID vs Steroid in Trabeculectomy Wound Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053083', 'term': 'bromfenac'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2018-11-16', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target IOP', 'timeFrame': '12 months', 'description': 'the proportion of patients achieving a target IOP range (≤21, ≤18, ≤15 or ≤12 mmHg) at 12 months post-operatively'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'This study will examine the efficacy of steroid vs NSAID treatment in relation to trabeculectomy wound management. Eligible study participants will be randomized to receive either steroid or NSAID topical treatment one week post-trabeculectomy. Each group will dose with their assigned study treatment until three months post-trabeculectomy. Study participants will be followed for twelve months post-trabeculectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients over the age of 18 years\n* Uncontrolled open angle glaucoma\n* Scheduled to undergo stand-alone trabeculectomy\n* No previous incisional glaucoma surgery\n* No ocular surgery of any kind in prior 6 months\n\nExclusion Criteria:\n\n* steroids and/or NSAIDs contraindicated\n* poor corneal epithelial health'}, 'identificationModule': {'nctId': 'NCT03751059', 'briefTitle': 'NSAID vs Steroid in Trabeculectomy Wound Management', 'organization': {'class': 'OTHER', 'fullName': 'Ivey Eye Institute'}, 'officialTitle': 'An Investigator-Initiated Multicenter Prospective Clinical Trial to Examine the Efficacy of Peri-operative NSAID vs Steroid Treatment in Trabeculectomy Wound Management', 'orgStudyIdInfo': {'id': 'TWM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NSAID', 'description': 'Bromfenac 0.07% Oph Susp: used from one week post-op to three months post-op', 'interventionNames': ['Drug: Bromfenac 0.07% Oph Susp']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Steroid', 'description': 'Dexamethasone: used from one week post-op to three months post-op', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Bromfenac 0.07% Oph Susp', 'type': 'DRUG', 'otherNames': ['Bromfenac'], 'description': 'Bromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group.', 'armGroupLabels': ['NSAID']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Topical dexamethasone to be used by all study participants for one week pre-trabeculectomy and by all study participants for one week post-trabeculectomy. At one week post-op, one of the treatment groups will continue to dose with dexamethasone.', 'armGroupLabels': ['Steroid']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'rboyd24@uwo.ca', 'phone': '519.646.6100', 'phoneExt': '66272'}], 'overallOfficials': [{'name': 'Cindy Hutnik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ivey Eye Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cindy Hutnik', 'class': 'OTHER'}, 'collaborators': [{'name': 'Glaucoma Research Society of Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cindy Hutnik', 'investigatorAffiliation': 'Ivey Eye Institute'}}}}