<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/NCT01660620</url>
  </required_header>
  <id_info>
    <org_study_id>108298</org_study_id>
    <nct_id>NCT01660620</nct_id>
  </id_info>
  <brief_title>Topical Betaxolol for the Prevention of Retinopathy of Prematurity</brief_title>
  <official_title>Topical Betaxolol for the Prevention of Retinopathy of Prematurity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Smith-Kettlewell Eye Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Smith-Kettlewell Eye Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We hypothesize that topical betaxolol will reduce the development of severe retinopathy of&#xD;
      prematurity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug is administered twice a day between 32 and 35 weeks gestational age, at a t ime when&#xD;
      ROP is most likely to arise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">November 2011</completion_date>
  <primary_completion_date type="Actual">November 2011</primary_completion_date>
  <phase>Phase 1</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 (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>development of apnea and or bradycardia</measure>
    <time_frame>3 weeks</time_frame>
    <description>babies were monitored and HR/RR monitored and recorded by masked observers, periodically</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>development of ROP requiring treatment</measure>
    <time_frame>7 weeks</time_frame>
    <description>Type I ROP was used as a secondary outcome measure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Development of Side Effects From Betaxolol</condition>
  <arm_group>
    <arm_group_label>betaxolol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>betaxolol 0.25% 2 per day for 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>masked labeling also 2 per day administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Betaxolol</intervention_name>
    <arm_group_label>betaxolol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>topical betaxolol</intervention_name>
    <description>given topically</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &lt;1251 grms birth weight&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ocular defect&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>32 Weeks</minimum_age>
    <maximum_age>32 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>January 2, 2013</last_update_submitted>
  <last_update_submitted_qc>January 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 3, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Smith-Kettlewell Eye Research Institute</investigator_affiliation>
    <investigator_full_name>William V Good, MD</investigator_full_name>
    <investigator_title>Administrator</investigator_title>
  </responsible_party>
  <keyword>betaxolol/ retinopathy of prematurity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Retinopathy of Prematurity</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Betaxolol</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/NCT01660620
org study id: 108298
nct id: NCT01660620
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
We hypothesize that topical betaxolol will reduce the development of severe retinopathy of
      prematurity.
The drug is administered twice a day between 32 and 35 weeks gestational age, at a t ime when
      ROP is most likely to arise.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: development of apnea and or bradycardia
time frame: 3 weeks
description: babies were monitored and HR/RR monitored and recorded by masked observers, periodically
measure: development of ROP requiring treatment
time frame: 7 weeks
description: Type I ROP was used as a secondary outcome measure
arm group label: betaxolol
arm group type: Experimental
description: betaxolol 0.25% 2 per day for 3 weeks
arm group label: placebo
arm group type: Placebo Comparator
description: masked labeling also 2 per day administration
intervention type: Drug
intervention name: Betaxolol
arm group label: betaxolol
intervention type: Drug
intervention name: topical betaxolol
description: given topically
arm group label: placebo
criteria: 
gender: All
minimum age: 32 Weeks
maximum age: 32 Weeks
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Smith-Kettlewell Eye Research Institute
investigator full name: William V Good, MD
investigator title: Administrator
mesh term: Retinal Diseases
mesh term: Retinopathy of Prematurity
mesh term: Premature Birth
mesh term: Betaxolol