<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/NCT04403334</url>
  </required_header>
  <id_info>
    <org_study_id>20180101</org_study_id>
    <nct_id>NCT04403334</nct_id>
  </id_info>
  <brief_title>Postoperative Safety Outcomes of Intraoperative Intracameral Preservative-Free Moxifloxacin Versus Levofloxacin</brief_title>
  <official_title>Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery With Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin Versus Levofloxacin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peregrine Eye and Laser Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peregrine Eye and Laser Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative&#xD;
      infection prophylaxis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized clinical trial comparing corneal and retinal changes after intracameral&#xD;
      levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing&#xD;
      uncomplicated phacoemulsification.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Actual">April 28, 2018</completion_date>
  <primary_completion_date type="Actual">April 28, 2018</primary_completion_date>
  <phase>Phase 4</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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>unlabelled syringe containing interventional drug</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial Cell Count</measure>
    <time_frame>3 months</time_frame>
    <description>Change in endothelial cell count as measured by specular microscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Central Retina Thickness</measure>
    <time_frame>3 months</time_frame>
    <description>Change in central retinal thickness as measured by spectral domain optical coherence tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>3 months</time_frame>
    <description>Onset of Adverse events following intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Cataract Senile</condition>
  <condition>Endophthalmitis</condition>
  <condition>Antibiotic Side Effect</condition>
  <condition>Safety Issues</condition>
  <arm_group>
    <arm_group_label>Intracameral levofloxacin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5% unpreserved solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intracameral moxifloxacin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5% unpreserved solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levofloxacin Ophthalmic</intervention_name>
    <description>0.1 ml of unpreserved 0.5% levofloxacin</description>
    <arm_group_label>Intracameral levofloxacin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moxifloxacin Ophthalmic</intervention_name>
    <description>0.1 ml of unpreserved 0.5% moxifloxacin</description>
    <arm_group_label>Intracameral moxifloxacin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eyes undergoing uncomplicated cataract surgery by phacoemulsification&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic&#xD;
             neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or&#xD;
             uncontrolled systemic disease and intraoperative complications that may affect visual&#xD;
             outcomes were excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harvey S Uy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peregrine Eye and Laser Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peregrine Eye and Laser Instittute</name>
      <address>
        <city>Makati City</city>
        <state>MM</state>
        <zip>1209</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peregrine Eye and Laser Institute</investigator_affiliation>
    <investigator_full_name>Harvey Siy Uy</investigator_full_name>
    <investigator_title>Medical Director</investigator_title>
  </responsible_party>
  <keyword>levofloxacin</keyword>
  <keyword>moxifloxacin</keyword>
  <keyword>prophylaxis</keyword>
  <keyword>endophthalmitis</keyword>
  <keyword>cataract surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endophthalmitis</mesh_term>
    <mesh_term>Cataract</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Moxifloxacin</mesh_term>
    <mesh_term>Levofloxacin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04403334
org study id: 20180101
nct id: NCT04403334
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative
      infection prophylaxis
Randomized clinical trial comparing corneal and retinal changes after intracameral
      levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing
      uncomplicated phacoemulsification.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: unlabelled syringe containing interventional drug
measure: Endothelial Cell Count
time frame: 3 months
description: Change in endothelial cell count as measured by specular microscopy
measure: Central Retina Thickness
time frame: 3 months
description: Change in central retinal thickness as measured by spectral domain optical coherence tomography
measure: Adverse Events
time frame: 3 months
description: Onset of Adverse events following intervention
arm group label: Intracameral levofloxacin
arm group type: Experimental
description: 0.5% unpreserved solution
arm group label: Intracameral moxifloxacin
arm group type: Experimental
description: 0.5% unpreserved solution
intervention type: Drug
intervention name: Levofloxacin Ophthalmic
description: 0.1 ml of unpreserved 0.5% levofloxacin
arm group label: Intracameral levofloxacin
intervention type: Drug
intervention name: Moxifloxacin Ophthalmic
description: 0.1 ml of unpreserved 0.5% moxifloxacin
arm group label: Intracameral moxifloxacin
criteria: 
gender: All
minimum age: 21 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harvey S Uy, MD
role: Principal Investigator
affiliation: Peregrine Eye and Laser Institute
facility: 
country: Philippines
responsible party type: Principal Investigator
investigator affiliation: Peregrine Eye and Laser Institute
investigator full name: Harvey Siy Uy
investigator title: Medical Director
mesh term: Endophthalmitis
mesh term: Cataract
mesh term: Moxifloxacin
mesh term: Levofloxacin