Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-06 @ 3:48 PM
Study NCT ID:
NCT06785194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Revive Toric RWE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2025-01-16', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator overall satisfaction as assessed by the Investigator Survey', 'timeFrame': 'Assessed 14 days ± 3 days after the final dispensing/refinement visit', 'description': '(completed by the Investigator for each subject at 14 days ± 3 days after the final dispensing/refinement visit)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Astigmatism']}, 'descriptionModule': {'briefSummary': 'This is a post-market observational clinical investigation. The objective of this observational study is to evaluate the visual performance and HCP satisfaction of REVIVE samfilcon B custom toric contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient population at study site locations', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Be 18 years or older on the date the ICF is signed\n2. Have the capacity to read, understand, and provide written voluntary informed consent\n3. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings\n4. Have no active ocular disease or allergic conjunctivitis\n5. Not be using any topical ocular medications\n6. Be willing and able to follow instructions\n7. Have signed a statement of informed consent\n8. Be an experienced soft contact lens wearer (have previously used soft contact lenses)\n9. Meet the indications per the Instructions for Use (IFU) and have a suitable prescription for treatment with the device\n\nExclusion Criteria:\n\n1. Is participating in another research study\n2. Is considered by the Investigator to not be a suitable candidate for participation\n3. Is not eligible for treatment with the study lens per the IFU (contraindicated)\n4. Has had previous ocular surgery\n5. Is taking/using ocular, systemic, or topical medications that, in the Investigator's opinion, could potentially affect ocular physiology or lens/solution performance"}, 'identificationModule': {'nctId': 'NCT06785194', 'briefTitle': 'Revive Toric RWE Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'Samfilcon B Custom Toric Lens Real-World Observational Study', 'orgStudyIdInfo': {'id': 'RWE-REV-P85-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'REVIVE samfilcon B custom toric contact lenses', 'description': 'REVIVE samfilcon B custom toric contact lenses', 'interventionNames': ['Device: REVIVE samfilcon B custom toric contact lenses']}], 'interventions': [{'name': 'REVIVE samfilcon B custom toric contact lenses', 'type': 'DEVICE', 'description': 'REVIVE samfilcon B custom toric contact lenses', 'armGroupLabels': ['REVIVE samfilcon B custom toric contact lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 101', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}, {'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 102', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}, {'zip': '30114', 'city': 'Canton', 'state': 'Georgia', 'country': 'United States', 'facility': 'Site 103', 'geoPoint': {'lat': 34.23676, 'lon': -84.49076}}], 'centralContacts': [{'name': 'Marjorie Rah', 'role': 'CONTACT', 'email': 'Marjorie.Rah@bausch.com', 'phone': '585-413-6397'}, {'name': 'Victoria Panagakis', 'role': 'CONTACT', 'email': 'victoria.panagakis@panacea85.com', 'phone': '+44 (0) 7967 756 504'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}