<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/NCT03244072</url>
  </required_header>
  <id_info>
    <org_study_id>PIND 134134</org_study_id>
    <nct_id>NCT03244072</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery</brief_title>
  <official_title>Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jason Ahee, M.D.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zion Therapeutics, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent&#xD;
      endophthalmitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo&#xD;
      after cataract surgery. They will be followed for one month to determine if there is a&#xD;
      statistically significant difference in the incidence of endophthalmitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2024</start_date>
  <completion_date type="Anticipated">October 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endophthalmitis after cataract surgery</measure>
    <time_frame>Subjects will undergo eye examinations at one day, one week, and one month post-operatively</time_frame>
    <description>Subjects will be followed after cataract surgery and have post-operative eye examinations to determine if infection in the eye (endophthalmitis) occurs during the study period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60000</enrollment>
  <condition>Endophthalmitis</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intracameral injection of moxifloxacin solution after cataract surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intracameral injection of placebo after cataract surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin</intervention_name>
    <description>Intracameral injection</description>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>active</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>intracameral injection</description>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>sham</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  visually significant cataracts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to fluoroquinolones, cobalamin (B12)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Ahee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zion Therapeutics, LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jason Ahee, M.D.</last_name>
    <phone>435-862-9865</phone>
    <email>aheejason@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zion Eye Institute</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Jason Ahee, M.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Zion Therapeutics, LLC</investigator_affiliation>
    <investigator_full_name>Jason Ahee, M.D.</investigator_full_name>
    <investigator_title>Medical Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endophthalmitis</mesh_term>
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Capsule Opacification</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxifloxacin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03244072
org study id: PIND 134134
nct id: NCT03244072
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent
      endophthalmitis
Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo
      after cataract surgery. They will be followed for one month to determine if there is a
      statistically significant difference in the incidence of endophthalmitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Endophthalmitis after cataract surgery
time frame: Subjects will undergo eye examinations at one day, one week, and one month post-operatively
description: Subjects will be followed after cataract surgery and have post-operative eye examinations to determine if infection in the eye (endophthalmitis) occurs during the study period.
arm group label: Treatment group
arm group type: Active Comparator
description: Intracameral injection of moxifloxacin solution after cataract surgery
arm group label: Placebo group
arm group type: Placebo Comparator
description: Intracameral injection of placebo after cataract surgery
intervention type: Drug
intervention name: Moxifloxacin
description: Intracameral injection
arm group label: Treatment group
other name: active
intervention type: Drug
intervention name: Placebo
description: intracameral injection
arm group label: Placebo group
other name: sham
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jason Ahee, M.D.
role: Principal Investigator
affiliation: Zion Therapeutics, LLC
last name: Jason Ahee, M.D.
phone: 435-862-9865
email: aheejason@hotmail.com
facility: 
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Zion Therapeutics, LLC
investigator full name: Jason Ahee, M.D.
investigator title: Medical Director
mesh term: Endophthalmitis
mesh term: Cataract
mesh term: Capsule Opacification
mesh term: Moxifloxacin
sharing ipd: Undecided