Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 9:13 AM
Study NCT ID:
NCT05550350
Status:
WITHDRAWN
Last Update Posted:
2025-08-11
First Post:
2022-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002123', 'term': 'Calcium Dobesilate'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No longer pursuing indication', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2022-09-16', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8", 'timeFrame': 'Day 8'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30', 'timeFrame': 'Days 1, 3, 15, and 30'}, {'measure': 'Mean ocular pain scores in the study eye', 'timeFrame': 'Days 1, 3, 8, 15 and 30', 'description': 'Numerical Ocular Pain Scale from 0-10 with 0 being no pain and 10 being most severe'}, {'measure': 'Proportion of subjects with absence of cells in the AC of the study eye', 'timeFrame': 'Days 1, 3, 8, 15 and 30'}, {'measure': 'Proportion of subjects with absence of flare in the AC of the study eye', 'timeFrame': 'Days 1, 3, 8, 15 and 30'}, {'measure': 'Mean AC cell score in the study eye', 'timeFrame': 'Days 1, 3, 8, 15 and 30', 'description': 'AC count by Slit Lamp Biomicroscopy with 0 being none and 4 being most severe'}, {'measure': 'Mean AC flare score in the study eye', 'timeFrame': 'Days 1, 3, 8, 15 and 30', 'description': 'AC count by Slit Lamp Biomicroscopy with 0 being absent and 4 being strong intensity'}, {'measure': 'Rates of ocular (study eye and fellow eye) and non-ocular TEAEs', 'timeFrame': 'up to day 30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery', 'detailedDescription': 'A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects at least 40 years of age scheduled for cataract surgery\n* Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye\n* Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye.\n\nExclusion Criteria:\n\n* Use of any corticosteroids within 7 days prior to Day 0\n* Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days\n* Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.'}, 'identificationModule': {'nctId': 'NCT05550350', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'EyePoint Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery', 'orgStudyIdInfo': {'id': 'EYP-DIP-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DEXYCU', 'description': 'DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg', 'interventionNames': ['Drug: Dexycu']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg', 'interventionNames': ['Other: Placebo/Vehicle']}], 'interventions': [{'name': 'Dexycu', 'type': 'DRUG', 'description': '103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg', 'armGroupLabels': ['DEXYCU']}, {'name': 'Placebo/Vehicle', 'type': 'OTHER', 'description': 'Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EyePoint Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}