Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-01-01 @ 12:20 PM
Study NCT ID:
NCT04549935
Status:
RECRUITING
Last Update Posted:
2020-09-16
First Post:
2020-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PRIME Study: A Randomized, Controlled, Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-08-28', 'mcpReleaseN': 1, 'releaseDate': '2023-08-01'}], 'estimatedResultsFirstSubmitDate': '2023-08-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D057240', 'term': 'Patient Preference'}], 'ancestors': [{'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D011239', 'term': 'Prednisolone'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-08-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Preference', 'timeFrame': 'Through Month 1', 'description': 'As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) survey (This is measured on a scale of 1-10 with 10 being a worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Percentage of eyes that have CME (Cystoid macular edema) post-operatively', 'timeFrame': 'Through Month 1', 'description': 'Measured by OCT (Optical Coherence Tomography )'}, {'measure': 'Mean pain score per eye (Group A vs Group B)', 'timeFrame': 'Through Month 1', 'description': 'Measured by Visual Analog Scale (0-10, 10 being the worst outcome)'}, {'measure': 'Incidence of post-operative corneal haze', 'timeFrame': 'Through Month 1', 'description': 'measured by OCT (Optical Coherence Tomography)'}, {'measure': 'Grade of post-operative corneal haze', 'timeFrame': 'Through Month 1', 'description': 'measured by OCT (Optical Coherence Tomography)'}, {'measure': 'Anterior chamber cell count', 'timeFrame': 'Through Month 1', 'description': 'measured by SUN Working Group Grading Scheme'}, {'measure': 'Uncorrected Visual Acuity', 'timeFrame': 'Through Month 1', 'description': 'measured by ETDRS chart a 4m'}, {'measure': 'Best Corrected Visual Acuity', 'timeFrame': 'Through Month 1', 'description': 'measured by ETDRS chart a 4m'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient Preference', 'Patient Outcomes', 'Post-Operative Inflammation', 'Grade of Post-Operative Cystoid Macular Edema', 'Rate of Post-Operative Cystoid Macular Edema']}, 'descriptionModule': {'briefSummary': 'To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.', 'detailedDescription': 'A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better\n* Willing and able to comply with clinic visits and study related procedures\n* Willing and able to sign the informed consent form\n\nExclusion Criteria:\n\n* Patients under the age of 22 or above the age of 75\n* Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).\n* Patients with active infectious ocular or extraocular disease.\n* Patients actively treated with local or systemic immunosuppression including systemic corticosteriods\n* Paitents with know hypersensitivity to Dexamethasone\n* Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator\n* Patients with a history of ocular inflammation or macular edema\n* Patients with allergy or inability to receive intracameral antibiotic\n* Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day\n* Patient with a corticosteriod implant (i.e. Ozurdex).\n* Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes'}, 'identificationModule': {'nctId': 'NCT04549935', 'briefTitle': 'The PRIME Study: A Randomized, Controlled, Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Vance Thompson Vision - MT'}, 'officialTitle': 'A Randomized, Controlled, PRospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza (Dexamethasone Ophthalmic Insert) 0.4 mg for the treatMEnt of Post-operative Inflammation in Patients Who Plan to Undergo Refractive Lens Exchange (RLE)', 'orgStudyIdInfo': {'id': 'The PRIME Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A Dextenza', 'description': 'Drug: Dextenza 0.4mg Opthalmic Insert The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion, The attributes of the insert reduce risks for improper corticosteriod tapering and unwanted peaks and troughs in drug concentration.', 'interventionNames': ['Drug: Dextenza']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B Topical Prednisolone', 'description': 'Drug: Topical Prednisolone Standard of care topical drop treatment', 'interventionNames': ['Drug: Topical Prednisolone']}], 'interventions': [{'name': 'Dextenza', 'type': 'DRUG', 'description': 'Dextenza 0.4mg', 'armGroupLabels': ['Group A Dextenza']}, {'name': 'Topical Prednisolone', 'type': 'DRUG', 'description': 'Standard of care topical drop treatment', 'armGroupLabels': ['Group B Topical Prednisolone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59718', 'city': 'Bozeman', 'state': 'Montana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Briana Parker', 'role': 'CONTACT', 'email': 'briana.parker@vancethompsonvision.com', 'phone': '406-599-5961'}, {'name': 'Keeley Puls', 'role': 'CONTACT', 'email': 'kpuls@vancethompsonvision.com', 'phone': '605 371-7075'}, {'name': 'Russell Swan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Travis Whitt, OD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Seirra Steiner, OD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Briana Parker', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vance Thompson Vision - MT', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}