Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-02 @ 3:31 AM
Study NCT ID:
NCT05044793
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jdickerson@sightsciences.com', 'phone': '1-877-266-1144', 'title': 'VP, Medical and Clinical Affairs', 'organization': 'Sight Sciences, Inc.'}, 'certainAgreement': {'otherDetails': "The institution or PI will submit a copy of any proposed publication/disclosure to Sponsor, at least sixty (60) days prior to submission. Sponsor may request changes or other measures to ensure the information is fairly stated. At Sponsor's request the Institution and/or the PI shall not publish/disclose information related to the Study. If Sponsor indicates that such publication or disclosure contains Confidential Information, the Institution and PI agree to remove such Confidential Information", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '36 months', 'description': 'Adverse events were collected from the time of the study procedure (retrospective data) through the 36-month visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A', 'description': 'Pre-operative washout of ocular hypotensive medications.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 27, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Cohort B', 'description': 'No pre-operative washout of ocular hypotensive medications.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ocular adverse events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 35, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Adverse events', 'notes': 'Fell and cracked hip. Surgery required.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Safety Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A', 'description': 'Pre-operative washout of ocular hypotensive medications.'}, {'id': 'OG001', 'title': 'Cohort B', 'description': 'No pre-operative washout of ocular hypotensive medications.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Rate of occurrence of sight-threatening adverse events', 'unitOfMeasure': 'adverse event', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT/Safety population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A', 'description': 'Reduction in mean unmedicated diurnal IOP (DIOP) from the preoperative unmedicated DIOP'}, {'id': 'OG001', 'title': 'Cohort B', 'description': 'Reduction in mean medicated IOP from pre-operative medicated IOP'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.89', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '-11.00', 'spread': '16.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Mean change in IOP', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Hypotensive Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A', 'description': 'Reduction in mean number of IOP lowering medications from pre-washout (pre-surgical) baseline at 36 months'}, {'id': 'OG001', 'title': 'Cohort B', 'description': 'Reduction in mean number of IOP lowering medications from pre-surgical baseline at 36 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Reduction in number of hypotensive medications from baseline to 36 months', 'unitOfMeasure': 'number of medications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A', 'description': '≥20% reduction in unmedicated diurnal IOP from baseline to 36 months'}, {'id': 'OG001', 'title': 'Cohort B', 'description': '≥20% reduction in mean medicated IOP from baseline to 36 months'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'For subjects in cohort A : ≥20% reduction in unmedicated diurnal IOP from baseline to 36 months For subjects in cohort B: ≥20% reduction in mean medicated IOP from baseline to 36 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A', 'description': 'Unmedicated diurnal IOP between 6 and 18 mmHg inclusive'}, {'id': 'OG001', 'title': 'Cohort B', 'description': 'Medicated IOP between 6 and 18 mmHg inclusive'}], 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'For cohort A: unmedicated diurnal IOP between 6 and 18 mmHg inclusive For cohort B: medicated IOP between 6 and 18 mmHg inclusive', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A', 'description': 'Subjects who had a pre-surgical washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment.'}, {'id': 'FG001', 'title': 'Cohort B', 'description': 'Subjects without a pre-surgical washout of ocular hypotensive medications with pre-surgical medicated IOP≥18 mmHg and on 1 to 5 hypotensive medications and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A', 'description': 'Pre-operative washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg'}, {'id': 'BG001', 'title': 'Cohort B', 'description': 'No pre-operative washout of ocular hypotensive medications with pre-operative medicated IOP ≥18 mmHg and on 1 to 5 hypotensive medications'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.6', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '68.0', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '71.4', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age at consent', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The Intent-to-Treat (ITT) analysis population included all subjects who were enrolled and treated, regardless of whether or not they had a protocol deviation'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-18', 'size': 1742704, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-21T01:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2021-09-09', 'resultsFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-21', 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Intraocular Pressure (IOP)', 'timeFrame': '12 months', 'description': 'Mean change in IOP'}, {'measure': 'Change in Hypotensive Medications', 'timeFrame': '12 months', 'description': 'Reduction in number of hypotensive medications from baseline to 36 months'}, {'measure': 'Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months', 'timeFrame': '12 months', 'description': 'For subjects in cohort A : ≥20% reduction in unmedicated diurnal IOP from baseline to 36 months For subjects in cohort B: ≥20% reduction in mean medicated IOP from baseline to 36 months'}, {'measure': 'Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive.', 'timeFrame': '12 months', 'description': 'For cohort A: unmedicated diurnal IOP between 6 and 18 mmHg inclusive For cohort B: medicated IOP between 6 and 18 mmHg inclusive'}], 'primaryOutcomes': [{'measure': 'Primary Safety Endpoint', 'timeFrame': '12 months', 'description': 'Rate of occurrence of sight-threatening adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Glaucoma, Open-Angle']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who received treatment and completed Protocol #06213', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n• Participated in, received treatment, and completed Protocol #06213\n\nExclusion Criteria:\n\n* Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits\n* Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)"}, 'identificationModule': {'nctId': 'NCT05044793', 'briefTitle': 'A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sight Sciences, Inc.'}, 'officialTitle': 'A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)', 'orgStudyIdInfo': {'id': '07408'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Subjects who had a surgical washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment.', 'interventionNames': ['Device: OMNI® Surgical System']}, {'label': 'Cohort B', 'description': 'Subjects without a surgical washout of ocular hypotensive medications with pre-surgical medicated IOP≥18 mmHg and on 1 to 5hypotensive medications and were treated with OMNI Surgical System for OAG in combination with cataract extraction at least 700 days prior to study enrollment.', 'interventionNames': ['Device: OMNI® Surgical System']}], 'interventions': [{'name': 'OMNI® Surgical System', 'type': 'DEVICE', 'description': "The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.", 'armGroupLabels': ['Cohort A', 'Cohort B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62708', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Grene Vision Group', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Eye Surgeons', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19406', 'city': 'Jenkintown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Northern Ophthalmics', 'geoPoint': {'lat': 40.09594, 'lon': -75.12517}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'El Paso Eye Surgeons', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sight Sciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}