Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 10:42 AM
Study NCT ID:
NCT03861169
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2019-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of OMNI System in OAG (GEMINI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014130', 'term': 'Trabeculectomy'}], 'ancestors': [{'id': 'D018463', 'term': 'Filtering Surgery'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trodriguez@sightsciences.com', 'phone': '818-687-3310', 'title': 'Tommie Rodriguez, Senior Clinical Research Manager', 'organization': 'Sight Sciences'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 Months', 'eventGroups': [{'id': 'EG000', 'title': 'iTT/Safety', 'description': 'The ITT/Safety population, defined as all enrolled and treated subjects regardless of whether or not they had a protocol deviation, comprised 149 subjects. All safety evaluations were performed on this population.', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 34, 'seriousNumAtRisk': 149, 'deathsNumAffected': 34, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Posterior capsular tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of 2 lines or more BCVA (10 or more ETDRS letters) at or after 3 months postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic anterior uveitis', 'notes': 'Inflammation of grade 1+ or worse persisting for more than 3 months post-operatively or that recurs less than three months after discontinuing treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Layered hyphema greater than or equal to 1mm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Anterior Synechiae >1 clock hour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vitreous hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clinically significant cystoid macular edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in C/D ratio of > 0.3 units compared to baseline on slit lamp exam', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IOP increase requiring management with systemic medication at greater than or equal to 1 month visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IOP increase greater than or equal to 10 mmHg above baseline IOP at greater than or equal to 1M', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystoid macular edema (CME)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Guttae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Microhyphema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Posterior capsular opacification (PCO)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial punctate keratitis (SPK)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Torn rotator cuff subsequent to fainting (Unrelated)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia (Unrelated)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Unmedicated Diurnal IOP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol Population', 'description': 'Primary inference was based on the PP population.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.98', 'spread': '4.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Change in mean unmedicated diurnal IOP from baseline to 12 months', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol (PP) analysis population was a subset of the mITT population and included all subjects who were on least one ocular hypotensive medication at screening and had uneventful cataract extraction followed by ab-interno transluminal viscoelastic delivery and trabeculotomy, 12 month IOP and medication data, and had no clinically significant protocol deviations.'}, {'type': 'PRIMARY', 'title': 'Change in Mean Number of IOP-Lowering Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol Population', 'description': 'Primary inference was based on the PP population.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.43', 'spread': '1.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Reduction in mean number of IOP-lowering medications from screening to 12 months', 'unitOfMeasure': 'medications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol Population', 'description': 'Based on Per Protocol population.'}, {'id': 'OG001', 'title': 'mITT', 'description': 'Based on mITT population.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000'}, {'value': '75.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'First Secondary Effectiveness endpoint/Percent of eyes with a ≥20% reduction in unmedicated DIOP at 12 months', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol Population', 'description': 'Based on Per Protocol population.'}, {'id': 'OG001', 'title': 'mITT', 'description': 'Based on mITT population.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000'}, {'value': '70.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Second Secondary Effectiveness Endpoint: Unmedicated DIOP ≥ 6 mmHg and ≤ 18 mmHg at 12 Months/Percent of eyes with unmedicated DIOP between 6 and 18 mmHg inclusive at 12 months', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OMNI® Surgical System', 'description': 'Cataract extraction followed by ab-interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OMNI® Surgical System', 'description': 'Eligible subjects had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤33 mmHg on 1 to 4 hypotensive medications at Screening and Cataract extraction followed by ab-interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'ITT/Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68.3', 'spread': '8.5', 'groupId': 'BG000'}]}]}, {'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68.6', 'spread': '8.3', 'groupId': 'BG000'}]}]}, {'title': 'Per Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '68.8', 'spread': '8.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Across three study populations (Safety/ITT, mITT, PP)'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'ITT/Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '89', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}, {'title': 'Per Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Across three study populations (Safety/ITT, mITT, PP)'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'ITT/Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Per Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Across three study populations (Safety/ITT, mITT, PP)'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'ITT/Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '122', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '115', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Per Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Across three study populations (Safety/ITT, mITT, PP)'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Study Eye', 'classes': [{'title': 'ITT/Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'categories': [{'title': 'OD', 'measurements': [{'value': '74', 'groupId': 'BG000'}]}, {'title': 'OS', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}]}, {'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}]}], 'categories': [{'title': 'OD', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': 'OS', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}, {'title': 'Per Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'categories': [{'title': 'OD', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'OS', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Across three study populations (Safety/ITT, mITT, PP)'}, {'title': 'Glaucoma Status', 'classes': [{'title': 'ITT/Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Primary Open Angle Glaucoma', 'measurements': [{'value': '139', 'groupId': 'BG000'}]}, {'title': 'Pigmentary', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Pseudoexfoliative', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'mITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Primary Open Angle Glaucoma', 'measurements': [{'value': '131', 'groupId': 'BG000'}]}, {'title': 'Pigmentary', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Pseudoexfoliative', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Per Protocol Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Primary Open Angle Glaucoma', 'measurements': [{'value': '113', 'groupId': 'BG000'}]}, {'title': 'Pigmentary', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Pseudoexfoliative', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Across three study populations (Safety/ITT, mITT, PP)'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-01', 'size': 2783408, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-18T13:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2019-02-25', 'resultsFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2019-02-28', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-22', 'studyFirstPostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Unmedicated Diurnal IOP', 'timeFrame': '12 months', 'description': 'Change in mean unmedicated diurnal IOP from baseline to 12 months'}, {'measure': 'Change in Mean Number of IOP-Lowering Medications', 'timeFrame': '12 months', 'description': 'Reduction in mean number of IOP-lowering medications from screening to 12 months'}], 'secondaryOutcomes': [{'measure': 'Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP', 'timeFrame': '12 months', 'description': 'First Secondary Effectiveness endpoint/Percent of eyes with a ≥20% reduction in unmedicated DIOP at 12 months'}, {'measure': 'Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months', 'timeFrame': '12 months', 'description': 'Second Secondary Effectiveness Endpoint: Unmedicated DIOP ≥ 6 mmHg and ≤ 18 mmHg at 12 Months/Percent of eyes with unmedicated DIOP between 6 and 18 mmHg inclusive at 12 months'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'This study will prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed using the OMNI Surgical System in combination with Cataract Extraction on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with mild-moderate open angle glaucoma (OAG).', 'detailedDescription': 'This prospective, multicenter, single-arm, post-market clinical study will evaluate the impact of ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System in conjunction with cataract surgery on IOP and the use of hypotensive medications in patients with mild to moderate open angle glaucoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOnly one eye of each subject was eligible (the "study eye"), and all ocular criteria listed below applied to the study eye.\n\n1. Male or female subjects, 22 years or older\n2. Visually significant cataract\n3. Diagnosed with mild to moderate open-angle glaucoma (e.g., primary open-angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects\' medical record per ICD-10 guidelines\n4. At screening, a medicated IOP ≤ 33 mmHg and on 1-4 IOP-lowering medications1 with a stable medication regimen for two months prior to screening visit\n5. At baseline, unmedicated diurnal IOP 21-36 mmHg and IOP at least 3 mmHg higher than screening IOP\n6. Scheduled for cataract extraction followed by ab- interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System\n7. Shaffer grade of ≥ 3 in all four quadrants\n8. Potential of good best corrected visual acuity post cataract extraction, in the Investigator\'s judgment\n9. Able and willing to comply with the protocol, including all follow-up visits.\n10. Understood and signed the informed consent\n\nExclusion Criteria:\n\nAll criteria listed below applied to the study eye; both eyes of a single subject need not have been eligible for the study.\n\n1. Any of the following prior treatments for glaucoma:\n\n * Laser trabeculoplasty ≤ 3 months prior to baseline\n * Implanted with iStent, CyPass, Xen, Express, glaucoma draining device/valve, or Hydrus Device\n * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC\n2. Normal tension glaucoma\n3. Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma\n4. Severe glaucoma as documented in subjects\' medical record per ICD-10 guidelines\n5. Use of oral hypotensive medication treatment for glaucoma\n6. In the Investigator\'s judgement, predisposed to significant risk because of washout of ocular hypotensive medications\n7. Ocular pathology or medical condition which, in the Investigator\'s judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch\'s dystrophy, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator\'s office for follow-up visits)\n8. Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator\n9. Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study'}, 'identificationModule': {'nctId': 'NCT03861169', 'briefTitle': 'Study of OMNI System in OAG (GEMINI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sight Sciences, Inc.'}, 'officialTitle': 'Prospective, Multi-Center, Single-Arm Post-Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma', 'orgStudyIdInfo': {'id': '06213'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Viscoeleastic delivery & trabeculotomy', 'description': 'Patients with open angle glaucoma and cataract', 'interventionNames': ['Device: Transluminal viscoelastic delivery and trabeculotomy']}], 'interventions': [{'name': 'Transluminal viscoelastic delivery and trabeculotomy', 'type': 'DEVICE', 'description': 'Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System', 'armGroupLabels': ['Viscoeleastic delivery & trabeculotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36301', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Eye Center South', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '86403', 'city': 'Lake Havasu City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barnet Delaney Perkins Eye Center', 'geoPoint': {'lat': 34.4839, 'lon': -114.32245}}, {'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Vold Vision', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '33326', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Your Eye Specialists', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Omni Eye Services', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '52245', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Eye Physicians and Surgeons, LLP', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '62708', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Grene Vision Group', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '59718', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'Vance Thompson Vision - MT', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}, {'zip': '68154', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Vance Thompson Vision - NE', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '58708', 'city': 'West Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision - ND', 'geoPoint': {'lat': 46.87497, 'lon': -96.90036}}, {'zip': '73104', '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}}, {'zip': '76102', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '53142', 'city': 'Kenosha', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Eye Centers of Racine and Kenosha', 'geoPoint': {'lat': 42.58474, 'lon': -87.82119}}], 'overallOfficials': [{'name': 'Jaime Dickerson, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sight Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sight Sciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}