Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-01 @ 1:48 PM
Study NCT ID:
NCT04563559
Status:
WITHDRAWN
Last Update Posted:
2021-11-17
First Post:
2020-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREFERENTIAL Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'C009935', 'term': 'prednisolone acetate'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI decided not to open study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of patients who stated they preferred dexamethasone insert as measured by patient report', 'timeFrame': '45 days post second surgery', 'description': 'To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.'}, {'measure': 'Percent of patients who stated they preferred topical prednisolone insert as measured by patient report', 'timeFrame': '45 days post second surgery', 'description': 'To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.'}], 'secondaryOutcomes': [{'measure': 'The incidence of AE', 'timeFrame': 'Up to 3 months', 'description': 'The incidence of adverse events'}, {'measure': 'The severity of AE', 'timeFrame': 'Up to 3 months', 'description': 'The severity of adverse events'}, {'measure': 'Resolution of inflammation', 'timeFrame': 'Day 14 post surgery', 'description': 'Resolution of inflammation as defined as either 0 or 0.5 cells or less cells on post-surgical day 14 as measured by SUN scale in an unmasked fashion.'}, {'measure': 'Resolution of pain', 'timeFrame': 'Day 7 post surgery', 'description': 'Resolution of pain as defined by a score of 0 measured by pain scale on post-surgical day 7'}, {'measure': 'Absence of cell flare at day 14', 'timeFrame': 'Day 14 post surgery', 'description': 'Absence of cell flare at day 14'}, {'measure': 'Mean change in BCVA', 'timeFrame': 'Baseline, 3 months', 'description': 'Mean change in BCVA'}, {'measure': 'Mean change in central retinal thickness as measured by OCT', 'timeFrame': 'Baseline, 3 months', 'description': 'Mean change in central retinal thickness as measured by OCT'}, {'measure': 'Percent of patients who maintained normalized central retinal thickness at 28 days post surgery', 'timeFrame': '28 days post surgery', 'description': 'Percent of patients who maintained normalized central retinal thickness at 28 days post surgery'}, {'measure': 'Percent of patients with rebound inflammation', 'timeFrame': 'Up to 3 months', 'description': 'Percent of patients with rebound inflammation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract Surgery', 'Glaucoma Surgery']}, 'descriptionModule': {'briefSummary': 'To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by - Modified COMTOL survey.', 'detailedDescription': 'Eyes from 80 patients will be randomized in a 1:1 ratio to the assigned treatment, dexamethasone insert placed at the time of surgery, or topical prednisolone acetate 1% therapy prescribed on a tapering dose schedule post-operatively.\n\nMales and Females 18 years and older with 1)Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole corrected distance visual acuity (CDVA) of at least 20/200 in both eyes and 2) 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber Intraocular Len (IOL) combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes.\n\nStudy visits will consist of eye exam with ocular photos from an Optical Coherence Tomography (OCT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole CDVA of at least 20/200 in both eyes\n* 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber IOL combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes\n\nExclusion Criteria:\n\n* Active or history of chronic or recurrent inflammatory eye disease in either eye\n* Ocular pain in either eye\n* Proliferative diabetic retinopathy in either eye\n* Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye\n* Laser or incisional ocular surgery during the study period and 6 months prior in either eye\n* Systemic concomitant pain medication management with pharmacologic class of oxycodone\n* Systemic NSAID use\n\n o Pre-procedural wash-out period for topical NSAIDS, ocular steroid, cyclosporine of 7 days\n* Clinically significant macular edema (CSME)\n* History of cystoid macular edema in the study eye'}, 'identificationModule': {'nctId': 'NCT04563559', 'briefTitle': 'PREFERENTIAL Study', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Patient PReference, Efficacy, and SaFety of an Intracanalicular DExamenthasone InseRt comparEd to Topical PrednisoloNe in PatienTs UndergoIng SequentiAl PhacoemuLsification With Intraocular Lens Surgery OR Combined Phacoemulsification With IOL and a Minimally Invasive Glaucoma Surgery (MIGS)', 'orgStudyIdInfo': {'id': 'Pro00104649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'DEXTENZA vs prednisolone acetate 1%)', 'description': 'Subjects will randomly receive Dextenza or prednisolone acetate 1% in the first eye after surgery. At the time of the second eye surgery, the other eye will receive the drug that the first eye did not receive. Subjects will receive both drugs during the course of the study and therefore there is only 1 ARM for this study.', 'interventionNames': ['Drug: Dextenza 0.4Mg Ophthalmic Insert', 'Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]']}], 'interventions': [{'name': 'Dextenza 0.4Mg Ophthalmic Insert', 'type': 'DRUG', 'description': 'The eye will have a sustained release device of Dexamethasone 0.4 mg placed in the inferior nasal lacrimal system.', 'armGroupLabels': ['DEXTENZA vs prednisolone acetate 1%)']}, {'name': 'Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]', 'type': 'DRUG', 'description': 'The eye will be randomized to receive topical treatment with prednisolone acetate 1% on a tapering dose schedule', 'armGroupLabels': ['DEXTENZA vs prednisolone acetate 1%)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Leon Herndon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Eye Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ocular Therapeutix, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}