<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/NCT04400916</url>
  </required_header>
  <id_info>
    <org_study_id>0424-19-RMB</org_study_id>
    <nct_id>NCT04400916</nct_id>
  </id_info>
  <brief_title>Topical Tranexamic Acid After Intravitreal Injections</brief_title>
  <official_title>Topical Use of Tranexamic Acid for Prevention of Subconjunctival Hemorrhage After Intravitreal Injections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We aim to investigate whether topical administration of Tranexamic acid can reduce the&#xD;
      occurence of subconjunctival hemorrahge after routine intravitreal injections for retinal&#xD;
      conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2021</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subconjunctival hemorrahge</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Subconjunctival Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Topical tranexamic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Topical BSS</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid</intervention_name>
    <description>A single drop administered topically</description>
    <arm_group_label>Topical tranexamic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balanced Salt Solution</intervention_name>
    <description>A single drop administered topically</description>
    <arm_group_label>Topical BSS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects receiving intravitreal injections as part of their routine ophthalmological care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pregnancy, Oral contraceptives/HRT use, Known systemic autoimmune disease, Renal failure,&#xD;
        active/suspected infection or inflammation in the treated eye, subconjunctival hemorrahge&#xD;
        prior to inclusion, History of subarachnoid hemorrahge, thromboembolic events, increased&#xD;
        risk for thromboembolic events, known sensitivity to the study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 20, 2020</last_update_submitted>
  <last_update_submitted_qc>May 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>Shiri Soudry MD</investigator_full_name>
    <investigator_title>Attending faculty and vitreoretinal surgeon, Department of Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranexamic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04400916
org study id: 0424-19-RMB
nct id: NCT04400916
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
We aim to investigate whether topical administration of Tranexamic acid can reduce the
      occurence of subconjunctival hemorrahge after routine intravitreal injections for retinal
      conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Subconjunctival hemorrahge
time frame: 3 days
arm group label: Topical tranexamic acid
arm group type: Experimental
arm group label: Topical BSS
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Tranexamic acid
description: A single drop administered topically
arm group label: Topical tranexamic acid
intervention type: Other
intervention name: Balanced Salt Solution
description: A single drop administered topically
arm group label: Topical BSS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: Shiri Soudry MD
investigator title: Attending faculty and vitreoretinal surgeon, Department of Ophthalmology
mesh term: Hemorrhage
mesh term: Tranexamic Acid
sharing ipd: No