Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT06128369
Status:
TERMINATED
Last Update Posted:
2024-12-10
First Post:
2023-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-05-27', 'mcpReleaseN': 3, 'releaseDate': '2025-05-09'}, {'resetDate': '2025-07-10', 'mcpReleaseN': 4, 'releaseDate': '2025-06-24'}, {'resetDate': '2025-09-30', 'mcpReleaseN': 5, 'releaseDate': '2025-09-10'}, {'resetDate': '2025-12-10', 'mcpReleaseN': 6, 'releaseDate': '2025-11-24'}], 'estimatedResultsFirstSubmitDate': '2025-05-09'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009877', 'term': 'Endophthalmitis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'whyStopped': 'Sponsor decision to close study due to third-party administrative error preventing analysis of trial results. There was no issue in terms of quality of the investigational product, and no safety risk to any study subject.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of OCS-01 to control inflammation in subjects after cataract surgery', 'timeFrame': 'Visit 6 (Day 15)', 'description': "Absence of anterior chamber cells (i.e. score of '0')"}, {'measure': 'To evaluate the efficacy of OCS-01 to control pain in subjects after cataract surgery', 'timeFrame': 'Visit 4 (Day 4)', 'description': "Absence of pain (i.e. score of '0')"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ophthalmology', 'Topical Ophthalmic Solution', 'Eye Drop', 'Post-surgical'], 'conditions': ['Inflammation Eye', 'Pain, Postoperative', 'Cataract']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the efficacy and safety of OCS-01 in treating inflammation and pain in subjects following cataract surgery.', 'detailedDescription': 'This is a multi-center, randomized, double-masked, vehicle-controlled study, designed to evaluate the efficacy and safety of OCS-01 compared to vehicle in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1 to receive OCS-01 or vehicle once daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (Selection):\n\n* Provide written informed consent, approved by the appropriate ethics committee;\n* Able to comply with the study requirements and visit schedule;\n* At least 18 years of age of either sex or any race;\n* Will undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;\n* Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 \\[18 to 30 hours post- uncomplicated cataract surgery without vitreous loss\\]);\n\nExclusion Criteria:\n\n* Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;\n* Have only one functional eye (monocular);\n* Have any intraocular inflammation (e.g., white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 \\[prior to surgery\\]) slit-lamp examination;\n* Have a score \\> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \\[prior to surgery\\]) in the study eye \\*Additional inclusion/exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT06128369', 'acronym': 'OPTIMIZE-2', 'briefTitle': 'Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oculis'}, 'officialTitle': 'A Randomized, Double-masked, Vehicle-controlled Study Evaluating the Efficacy and Safety of OCS-01 Ophthalmic Suspension in the Treatment of Inflammation and Pain Following Cataract Surgery', 'orgStudyIdInfo': {'id': 'DX220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCS-01', 'description': 'dexamethasone ophthalmic suspension,1.5% \\[15 mg/mL\\]', 'interventionNames': ['Drug: Dexamethasone Ophthalmic Suspension']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle ophthalmic suspension', 'description': 'Vehicle of OCS-01', 'interventionNames': ['Other: Vehicle of OCS-01']}], 'interventions': [{'name': 'Dexamethasone Ophthalmic Suspension', 'type': 'DRUG', 'otherNames': ['OCS-01'], 'description': 'Ophthalmic Suspension,1.5% \\[15 mg/mL\\] Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).', 'armGroupLabels': ['OCS-01']}, {'name': 'Vehicle of OCS-01', 'type': 'OTHER', 'description': 'inert vehicle of OCS-01 ophthalmic suspension Subjects will dose 1 drop of OCS-01 in the study eye once daily for 14 days, beginning 1-day post-surgery in the operated eye (administration of first dose will be performed in the clinic on Day 1).', 'armGroupLabels': ['Vehicle ophthalmic suspension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '30260', 'city': 'Morrow', 'state': 'Georgia', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 33.58317, 'lon': -84.33937}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63090', 'city': 'Washington', 'state': 'Missouri', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 38.55811, 'lon': -91.01209}}, {'zip': '27909', 'city': 'Elizabeth City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 36.2946, 'lon': -76.25105}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '18704', 'city': 'Kingston', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 41.26175, 'lon': -75.89686}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77008', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Oculis Investigative Site', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oculis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ORA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}