<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/NCT02214680</url>
  </required_header>
  <id_info>
    <org_study_id>CMC-14-0016-CTIL</org_study_id>
    <secondary_id>CMC-14-0016</secondary_id>
    <nct_id>NCT02214680</nct_id>
  </id_info>
  <brief_title>The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter</brief_title>
  <official_title>The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carmel Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carmel Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan)&#xD;
      eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic&#xD;
      effect on the pupil, however the combined effect of alpha agonist and beta blocker has not&#xD;
      been studied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan)&#xD;
      eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic&#xD;
      effect on the pupil, however the combined effect of alpha agonist and beta blocker has not&#xD;
      been studied.&#xD;
&#xD;
      The study subjects will be examined twice, two weeks apart. On the first exam the subject&#xD;
      will receive Combigan eye drop to the right eye and a Brimonidine drop to the left eye. The&#xD;
      effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after&#xD;
      instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop&#xD;
      to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and&#xD;
      30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2015</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <phase>Phase 2</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pupil diameter</measure>
    <time_frame>two weeks</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Combination of Brimonidine and Timolol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>On the first exam the subject will receive Combigan (Combination of Brimonidine and Timolol) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Combigan (Combination of Brimonidine and Timolol)</intervention_name>
    <description>On the first exam the subject will receive Combigan (Combination of Brimonidine and Timolol) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.</description>
    <arm_group_label>Combination of Brimonidine and Timolol</arm_group_label>
    <other_name>Alphagan</other_name>
    <other_name>Tiloptic</other_name>
    <other_name>Combigan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Timolol</intervention_name>
    <description>0.5% eye drop</description>
    <arm_group_label>Combination of Brimonidine and Timolol</arm_group_label>
    <other_name>Tiloptic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults subjects with no ocular pathology&#xD;
&#xD;
          -  Non pregnant women&#xD;
&#xD;
          -  Normal pupil response&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic topical treatment&#xD;
&#xD;
          -  Systemic medication affecting autonomic nerve system&#xD;
&#xD;
          -  History of intra-ocular surgery&#xD;
&#xD;
          -  Irregular pupil&#xD;
&#xD;
          -  History of ocular neurological or severe cardio-vascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Orna Geyer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carmel Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Orna Geyer, Professor</last_name>
    <phone>97248250926</phone>
    <email>orna_geyer@clalit.org.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Carmel Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Zina Goldbaum</last_name>
      <phone>97248250441</phone>
      <email>zinago@clalit.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>October 13, 2015</last_update_submitted>
  <last_update_submitted_qc>October 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carmel Medical Center</investigator_affiliation>
    <investigator_full_name>Orna Geyer</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pupil diameter</keyword>
  <keyword>Brimonidine</keyword>
  <keyword>Timolol</keyword>
  <keyword>Combigan</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Timolol</mesh_term>
    <mesh_term>Brimonidine Tartrate</mesh_term>
    <mesh_term>Brimonidine Tartrate, Timolol Maleate Drug Combination</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/NCT02214680
org study id: CMC-14-0016-CTIL
secondary id: CMC-14-0016
nct id: NCT02214680
lead sponsor: 
has dmc: No
In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan)
      eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic
      effect on the pupil, however the combined effect of alpha agonist and beta blocker has not
      been studied.
In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan)
      eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic
      effect on the pupil, however the combined effect of alpha agonist and beta blocker has not
      been studied.

      The study subjects will be examined twice, two weeks apart. On the first exam the subject
      will receive Combigan eye drop to the right eye and a Brimonidine drop to the left eye. The
      effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after
      instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop
      to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and
      30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Pupil diameter
time frame: two weeks
arm group label: Combination of Brimonidine and Timolol
arm group type: Experimental
description: On the first exam the subject will receive Combigan (Combination of Brimonidine and Timolol) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.
intervention type: Drug
intervention name: Combigan (Combination of Brimonidine and Timolol)
description: On the first exam the subject will receive Combigan (Combination of Brimonidine and Timolol) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.
arm group label: Combination of Brimonidine and Timolol
other name: Alphagan
other name: Tiloptic
other name: Combigan
intervention type: Drug
intervention name: Timolol
description: 0.5% eye drop
arm group label: Combination of Brimonidine and Timolol
other name: Tiloptic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Orna Geyer, MD
role: Principal Investigator
affiliation: Carmel Medical Center
last name: Orna Geyer, Professor
phone: 97248250926
email: orna_geyer@clalit.org.il
facility: 
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Carmel Medical Center
investigator full name: Orna Geyer
investigator title: Professor
mesh term: Timolol
mesh term: Brimonidine Tartrate
mesh term: Brimonidine Tartrate, Timolol Maleate Drug Combination