<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04465630</url>
  </required_header>
  <id_info>
    <org_study_id>06807</org_study_id>
    <nct_id>NCT04465630</nct_id>
  </id_info>
  <brief_title>A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma</brief_title>
  <acronym>ORION</acronym>
  <official_title>A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sight Sciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sight Sciences, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery&#xD;
      and trabeculotomy performed with the OMNI Surgical System in pseudophakic eyes on intraocular&#xD;
      pressure (IOP) and the use of IOP-lowering medications in patients with open angle glaucoma&#xD;
      (OAG).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor Decision&#xD;
  </why_stopped>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">March 2, 2021</completion_date>
  <primary_completion_date type="Actual">March 2, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Intraocular Pressure (IOP)</measure>
    <time_frame>6 months</time_frame>
    <description>Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Medications</measure>
    <time_frame>6 months</time_frame>
    <description>Change in the number of ocular hypotensive medications between screening and 6 months for subjects who reached the 6-month post-operative timepoint by the time of study closure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <arm_group>
    <arm_group_label>Pseudophakic eyes with Open Angle Glaucoma</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>OMNI® Surgical System</intervention_name>
    <description>Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System</description>
    <arm_group_label>Pseudophakic eyes with Open Angle Glaucoma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects, 22 years or older at the time of surgery&#xD;
&#xD;
          -  History of uncomplicated cataract surgery and posterior chamber IOL implantation&#xD;
             without compromise to the lens capsule, zonular dehiscence/rupture or vitreous&#xD;
             prolapse, 6 months or more prior to Baseline Visit.&#xD;
&#xD;
          -  Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle glaucoma,&#xD;
             pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical&#xD;
             record substantiated using funduscopic exam or OCT and at least one visual field test&#xD;
             with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm.&#xD;
&#xD;
               -  Mean deviation score must be better than or equal to -12.0 dB&#xD;
&#xD;
               -  The visual field test may be historical (within 6 months prior to Screening&#xD;
                  Visit). If needed, visual field testing may be repeated between the Screening&#xD;
                  Visit and the Surgery Visit.&#xD;
&#xD;
          -  At the Screening visit, IOP of ≤ 36 mmHg while on 1-5 ocular hypotensive medications1&#xD;
             with a stable medication regimen for at least 2 months.&#xD;
&#xD;
          -  At Baseline visit, unmedicated diurnal i) IOP ≥ 22.5 and ≤ 39mmHg and ii) IOP at least&#xD;
             3 mmHg higher than screening IOP and iii) IOP at 7:30AM ≥ 24&#xD;
&#xD;
          -  Scheduled for ab-interno transluminal viscoelastic delivery and trabeculotomy using&#xD;
             the OMNI Surgical System.&#xD;
&#xD;
          -  Shaffer grade of ≥ III in all four quadrants&#xD;
&#xD;
          -  Able and willing to comply with the protocol, including all follow-up visits.&#xD;
&#xD;
          -  Understands and signs the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any of the following prior treatments for glaucoma:&#xD;
&#xD;
               -  Laser trabeculoplasty ≤3 months prior to Baseline visit&#xD;
&#xD;
               -  iStent or iStent Inject implanted ≤6 months prior to Baseline visit&#xD;
&#xD;
               -  Endocyclophotocoagulation (ECP) or Micropulse laser ≤ 6 months prior to Baseline&#xD;
                  visit&#xD;
&#xD;
               -  Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma&#xD;
                  draining device/valve&#xD;
&#xD;
               -  Prior canaloplasty, goniotomy, or trabeculotomy&#xD;
&#xD;
               -  Hydrus microstent&#xD;
&#xD;
               -  Suprachoroidal stent (e.g. Cypass, iStent Supra)&#xD;
&#xD;
          -  Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma&#xD;
&#xD;
          -  Concurrent IOP-lowering procedure other than use of the OMNI Surgical System at the&#xD;
             time of surgery (e.g. ECP, CPC, etc.)&#xD;
&#xD;
          -  In the Investigator's judgement, predisposed to significant risk because of washout of&#xD;
             ocular hypotensive medications&#xD;
&#xD;
          -  Concurrent ocular pathology or systemic medical condition which, in the Investigator's&#xD;
             judgment, would either place the subject at increased risk of complications,&#xD;
             contraindicate surgery, place the subject at risk of significant vision loss during&#xD;
             the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, active intraocular&#xD;
             infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere&#xD;
             with compliance to elements of the study protocol (e.g., returning to Investigator's&#xD;
             office for follow-up visits).&#xD;
&#xD;
          -  History of penetrating keratoplasty or another corneal transplant&#xD;
&#xD;
          -  BCVA of logMAR 1.0 (20/200) or worse in the fellow eye not due to cataract&#xD;
&#xD;
          -  Study of OMNI System in POAG&#xD;
&#xD;
          -  BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to posterior capsular&#xD;
             opacification (uneventful Nd:YAG laser capsulotomy 6 months prior to baseline is&#xD;
             permitted only if there is no vitreous present in or in front of the iris plane at the&#xD;
             time of baseline).&#xD;
&#xD;
          -  Participation (≤ 30 days prior to baseline) in an interventional trial which could&#xD;
             have a potential effect on the study outcome, as determined by the study investigator&#xD;
&#xD;
          -  Women of childbearing potential if they are currently pregnant or intend to become&#xD;
             pregnant during the study period; are breast-feeding; or are not in agreement to use&#xD;
             adequate birth control methods to prevent pregnancy throughout the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vold Vision</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Visionary Eye Institute</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Bay Eye Associates</name>
      <address>
        <city>Petaluma</city>
        <state>California</state>
        <zip>94954</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assil Eye Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grene Vision Group</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>62708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Eye Consultants</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Eye Surgeons</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Eye Specialists</name>
      <address>
        <city>Maryville</city>
        <state>Tennessee</state>
        <zip>37803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>El Paso Eye Surgeons</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology Associates - Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Eye Centers</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <results_first_submitted>March 9, 2022</results_first_submitted>
  <results_first_submitted_qc>May 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 7, 2022</results_first_posted>
  <last_update_submitted>June 6, 2022</last_update_submitted>
  <last_update_submitted_qc>June 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT04465630/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The enrollment period for the study lasted 7 months and the study included 11 sites across the USA</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Pseudophakic Eyes With Open Angle Glaucoma</title>
          <description>One eye of each eligible subject enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.&#xD;
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Sponsor Decision to terminate the study</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen failure</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Baseline failure</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects who received the study procedure</population>
      <group_list>
        <group group_id="B1">
          <title>Pseudophakic Eyes With Open Angle Glaucoma</title>
          <description>Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.&#xD;
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="54"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.2" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Intraocular Pressure (IOP)</title>
        <description>Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure</description>
        <time_frame>6 months</time_frame>
        <population>Overall mean change in IOP from baseline for subjects who reached the 6-month time point by study closure</population>
        <group_list>
          <group group_id="O1">
            <title>Pseudophakic Eyes With Open Angle Glaucoma</title>
            <description>One eye of each eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.&#xD;
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Intraocular Pressure (IOP)</title>
          <description>Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure</description>
          <population>Overall mean change in IOP from baseline for subjects who reached the 6-month time point by study closure</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.8" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Number of Medications</title>
        <description>Change in the number of ocular hypotensive medications between screening and 6 months for subjects who reached the 6-month post-operative timepoint by the time of study closure</description>
        <time_frame>6 months</time_frame>
        <population>Overall mean change in number of ocular hypotensive medications from Screening for enrolled subjects who reached the 6-month post-operative time point at the time of study closure</population>
        <group_list>
          <group group_id="O1">
            <title>Pseudophakic Eyes With Open Angle Glaucoma</title>
            <description>Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.&#xD;
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Number of Medications</title>
          <description>Change in the number of ocular hypotensive medications between screening and 6 months for subjects who reached the 6-month post-operative timepoint by the time of study closure</description>
          <population>Overall mean change in number of ocular hypotensive medications from Screening for enrolled subjects who reached the 6-month post-operative time point at the time of study closure</population>
          <units>number of hypotensive medications</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pseudophakic Eyes With Open Angle Glaucoma</title>
          <description>Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.&#xD;
OMNI® Surgical System: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary Artery Disease (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vitreous Hemorrhage (unrelated)</sub_title>
                <description>Intraoperative</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Iris Prolapse (unrelated)</sub_title>
                <description>Intraoperative</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Posterior Capsular Opacification (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Corneal edema after 1 week</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Layered hyphema greater than or equal to 1mm (unrelated)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Clinically significant cystoid macular edema (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>IOP increase of 10 mmHg above baseline IOP at 1 month or later</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Benign paroxysmal positional vertigo (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Blepharitis (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Headache (unrelated)</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Headache above left eye (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Iris atrophy (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Iris prolapse (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Macular edema (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Small blood clots in trabecular meshwork (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Superficial punctate keratitis (unrelated)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COVID-19 (unrelated)</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <description>SARS COV-2 infection</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Depending on certain terms described in the agreement, the Institution and Principal Investigator may publish the results of the Study generated by the Institution, subject to...the prior approval of Sponsor in writing. The Institution shall furnish Sponsor with a written copy of any proposed publication or disclosure,...at least sixty (60) days prior to submission for publication or disclosure.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Meaningful conclusions cannot be drawn due to early termination of the study due to a business decision.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Kavita Dhamdhere, MD</name_or_title>
      <organization>SIght Sciences, Inc</organization>
      <phone>877-266-1144</phone>
      <email>kdhamdhere@sightsciences.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04465630
org study id: 06807
nct id: NCT04465630
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery
      and trabeculotomy performed with the OMNI Surgical System in pseudophakic eyes on intraocular
      pressure (IOP) and the use of IOP-lowering medications in patients with open angle glaucoma
      (OAG).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Intraocular Pressure (IOP)
time frame: 6 months
description: Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure
measure: Change in Number of Medications
time frame: 6 months
description: Change in the number of ocular hypotensive medications between screening and 6 months for subjects who reached the 6-month post-operative timepoint by the time of study closure
arm group label: Pseudophakic eyes with Open Angle Glaucoma
arm group type: Other
description: Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System.
intervention type: Device
intervention name: OMNI® Surgical System
description: Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
arm group label: Pseudophakic eyes with Open Angle Glaucoma
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Meaningful conclusions cannot be drawn due to early termination of the study due to a business decision.
point of contact: 