Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-02-07 @ 11:47 AM
Study NCT ID:
NCT02137161
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2014-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D017889', 'term': 'Exfoliation Syndrome'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2014-05-12', 'studyFirstSubmitQcDate': '2014-05-12', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in anterior chamber inflammation measured by Laser Flare Photometry (photon counts per millisecond)', 'timeFrame': 'Baseline, Day 3', 'description': 'Reduction of 30% of anterior chamber inflammation evaluated by Laser Flare Photometry (LFP) in the bromfenac arm when compared to the non-bromfenac arm at postoperative day 3.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with central macular thickness greater than 300 microns', 'timeFrame': 'Baseline, Week 4', 'description': 'Macular thickness will be evaluated by Spectral Domain Optical Coherence Tomography (SD-OCT).'}, {'measure': 'Proportion of subjects with best corrected visual acuity equal to 20/20', 'timeFrame': 'Baseline, Week 1'}, {'measure': 'Proportion of patients who had no ocular pain', 'timeFrame': 'Baseline, Day 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract', 'Pseudoexfoliation Syndrome']}, 'descriptionModule': {'briefSummary': 'OBJECTIVE To evaluate the efficacy of bromfenac ophthalmic solution 0.09% for reducing postoperative inflammation in eyes with pseudoexfoliation syndrome (PEX) undergoing cataract surgery and receiving standard postoperative eye drops (dexamethasone 0.1% plus tobramycin 0.3% ophthalmic solution).\n\nDESIGN Two arms, parallel group, randomized, single center, prospective, phase IV clinical trial.\n\nPARTICIPANTS Sixty-two subjects with PEX and cataract will be sequentially assigned, according to a computer-generated randomization list (1:1), to bromfenac (n = 31) or not (n = 31).\n\nINTERVENTION Cataract surgery by means of phacoemulsification and implantation of posterior-chamber intraocular lens will be performed by two experienced ophthalmic surgeons.\n\nStandard Arm: only a standard antibiotic and steroid ophthalmic suspension will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).\n\nExperimental Arm: eyes will receive bromfenac BID for two weeks starting the day after surgery. Standard post-operative topical antibiotic and steroid will be also given concurrently, dosed QID for the first week and BID for the second week (dexamethasone 0.1% and tobramycin 0.3% eye drops association).\n\nMeasurements will be carried out at baseline and after one day, 3 days, 1 week and 4 weeks from cataract extraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cataract\n* pseudoexfoliation syndrome\n\nExclusion Criteria:\n\n* history of ocular inflammation or trauma\n* previous intraocular surgery\n* corneal haze\n* retinal vascular disease\n* diabetic retinopathy\n* variation of the foveal profile at OCT (macular edema, epiretinal membrane)\n* moderate to severe age related macular degeneration'}, 'identificationModule': {'nctId': 'NCT02137161', 'acronym': 'REPEX', 'briefTitle': 'Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Azienda USL Reggio Emilia - IRCCS'}, 'officialTitle': 'The Reggio Emilia Study on Bromfenac for Patients With PseudoEXfoliation Syndrome Undergoing Cataract Surgery: the REPEX Study', 'orgStudyIdInfo': {'id': '2013-002066-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone+Tobramycin eye drop', 'description': 'An antibiotic and steroid eye drop association will be given starting the day after the surgery for two weeks, dosed QID for the first week and BID for the second week, to 31 patients.', 'interventionNames': ['Drug: Dexamethasone+Tobramycin eye drop']}, {'type': 'EXPERIMENTAL', 'label': 'Bromfenac', 'description': 'Bromfenac eye drops (BID for two weeks starting the day after surgery) plus an antibiotic and steroid eye drop association (QID for the first week and BID for the second week) will be given concurrently to 31 patients.', 'interventionNames': ['Drug: Dexamethasone+Tobramycin eye drop', 'Drug: Bromfenac eye drop']}], 'interventions': [{'name': 'Dexamethasone+Tobramycin eye drop', 'type': 'DRUG', 'description': 'dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension', 'armGroupLabels': ['Bromfenac', 'Dexamethasone+Tobramycin eye drop']}, {'name': 'Bromfenac eye drop', 'type': 'DRUG', 'otherNames': ['Yellox'], 'description': 'bromfenac ophthalmic solution 0.09%', 'armGroupLabels': ['Bromfenac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42123', 'city': 'Reggio Emilia', 'state': 'RE', 'country': 'Italy', 'facility': 'Arcispedale Santa Maria Nuova IRCSS - Ophthalmology', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'overallOfficials': [{'name': 'Marco Coassin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arcispedale S. Maria Nuova IRCCS'}, {'name': 'Luigi Fontana, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Arcispedale S. Maria Nuova IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}