<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/NCT03249337</url>
  </required_header>
  <id_info>
    <org_study_id>EH17-320</org_study_id>
    <nct_id>NCT03249337</nct_id>
  </id_info>
  <brief_title>Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy</brief_title>
  <official_title>A Pilot Study For Efficacy And Safety Of Glanatec® Opthalmic Solution 0.4% On Corneal Edema And Endothelial Cell Counts In Subjects With Fuchs Endothelial Dystrophy Undergoing Descemet Stripping Without Endothelial Keratoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marian Macsai, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NorthShore University HealthSystem</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In brief, the objective of this study is to investigate whether the drug Glanatec ® which is&#xD;
      approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs&#xD;
      endothelial dystrophy who have had a descemet stripping procedure without endothelial&#xD;
      keratoplasty. While some limited data exists as a proof of concept in in vitro or animal&#xD;
      studies, and Glanatec® has been successfully used in a recently published case series for&#xD;
      this indication, there is insufficient data to show that this drug can be effectively used&#xD;
      for corneal cell clearing while maintaining patient safety.&#xD;
&#xD;
      The goal of the study is to provide sufficient proof of concept for the use of this drug in&#xD;
      patients with FED whose only treatment alternative is to undergo corneal transplant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 6, 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corneal Clearing</measure>
    <time_frame>12 months</time_frame>
    <description>The first primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly increases corneal clearing at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pachymetry measurement</measure>
    <time_frame>12 months</time_frame>
    <description>The second primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly reduces the pachymetry measurement at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>12 months</time_frame>
    <description>The secondary aim of this study is to examine whether Glanatec® administered three or six times daily affects best corrected visual acuity at 12 months (measured by Snellen lines) as compared to baseline, patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Fuchs' Endothelial Dystrophy</condition>
  <arm_group>
    <arm_group_label>Glanatec(R) 3 times a day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Glanatec (R) 6 times a day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ripasudil hydrochloride hydrate 0.4% ophthalmic solution</intervention_name>
    <description>the ophthalmic solution will be administered three or six per times per day in the eye designated as the &quot;Study Eye&quot; upon study enrollment</description>
    <arm_group_label>Glanatec (R) 6 times a day</arm_group_label>
    <arm_group_label>Glanatec(R) 3 times a day</arm_group_label>
    <other_name>Glanatec</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Ability to understand read and sign the informed consent form.&#xD;
&#xD;
               -  Age between 30 and &lt;91 years&#xD;
&#xD;
               -  Ability to understand and follow instructions and study procedures&#xD;
&#xD;
               -  Willingness to comply with all study procedures and be available for the duration&#xD;
                  of the study&#xD;
&#xD;
               -  Ability to apply eye drop medication and willing to adhere to study medication&#xD;
                  regimen&#xD;
&#xD;
               -  Diagnosed with Fuchs dystrophy (clinically and on confocal microscopy) by the&#xD;
                  study investigator.&#xD;
&#xD;
               -  Pseudophakic FED with posterior capsule supported, suture-fixated, or&#xD;
                  sulcus-supported posterior chamber intraocular lens.&#xD;
&#xD;
               -  Fuchs dystrophy grades 2-4 on the Krachmer grading scale&#xD;
&#xD;
               -  Presence of central guttae deemed by the investigator to be the chief cause of&#xD;
                  visual symptoms, rather than cataract or corneal stromal edema&#xD;
&#xD;
               -  Clear peripheral cornea with an endothelial cell count &gt;1000 cells/mm2 on&#xD;
                  specular microscopy&#xD;
&#xD;
               -  Best corrected visual acuity in the study eye is 20/40 or worse at study&#xD;
                  enrollment&#xD;
&#xD;
               -  The patient is dissatisfied with current vision&#xD;
&#xD;
               -  The patient is otherwise to be offered a corneal graft&#xD;
&#xD;
               -  For females with reproductive potential, willingness to use highly effective&#xD;
                  contraception (e.g., hormonal contraception, barrier contraception, intrauterine&#xD;
                  device, or abstinence).&#xD;
&#xD;
               -  Indication for surgery may include cataract extraction and posterior chamber&#xD;
                  intraocular lens implantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Uncontrolled glaucoma (IOP &gt;25 mmHg)&#xD;
&#xD;
               -  Presence of secondary corneal pathology such as infective or autoimmune keratitis&#xD;
&#xD;
               -  Advanced corneal stromal edema defined as the presence of haze, bullae, or DM&#xD;
                  folds on slit-lamp biomicroscopy&#xD;
&#xD;
               -  History of herpes simplex virus or cytomegalovirus keratitis&#xD;
&#xD;
               -  Prior endothelial keratoplasty&#xD;
&#xD;
               -  Aphakic in study eye.&#xD;
&#xD;
               -  Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be&#xD;
                  used in the course of the study&#xD;
&#xD;
               -  For women of child-bearing potential: Pregnant or lactating, or planning to&#xD;
                  become pregnant within the next 6 months.&#xD;
&#xD;
               -  Any other ocular condition that, in the opinion of the investigator, may preclude&#xD;
                  the subject from study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>91 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Duanny Alva, MPH</last_name>
    <phone>847-570-1783</phone>
    <email>dalva@northshore.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marian Macsai, MD</last_name>
    <phone>847-657-1936</phone>
    <email>mmacsai@northshore.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NorthShore University HealthSystem</name>
      <address>
        <city>Glenview</city>
        <state>Illinois</state>
        <zip>60026</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Duanny Alva, MPH</last_name>
      <phone>847-570-1783</phone>
      <email>dalva@northore.org</email>
    </contact>
    <investigator>
      <last_name>Marian Macsai, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 9, 2021</last_update_submitted>
  <last_update_submitted_qc>August 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>NorthShore University HealthSystem</investigator_affiliation>
    <investigator_full_name>Marian Macsai, MD</investigator_full_name>
    <investigator_title>Chief Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fuchs' Endothelial Dystrophy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 11, 2023</submitted>
    <returned>June 9, 2023</returned>
  </pending_results>
  <!-- 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/NCT03249337
org study id: EH17-320
nct id: NCT03249337
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
In brief, the objective of this study is to investigate whether the drug Glanatec ® which is
      approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs
      endothelial dystrophy who have had a descemet stripping procedure without endothelial
      keratoplasty. While some limited data exists as a proof of concept in in vitro or animal
      studies, and Glanatec® has been successfully used in a recently published case series for
      this indication, there is insufficient data to show that this drug can be effectively used
      for corneal cell clearing while maintaining patient safety.

      The goal of the study is to provide sufficient proof of concept for the use of this drug in
      patients with FED whose only treatment alternative is to undergo corneal transplant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Corneal Clearing
time frame: 12 months
description: The first primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly increases corneal clearing at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping
measure: pachymetry measurement
time frame: 12 months
description: The second primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly reduces the pachymetry measurement at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.
measure: Visual Acuity
time frame: 12 months
description: The secondary aim of this study is to examine whether Glanatec® administered three or six times daily affects best corrected visual acuity at 12 months (measured by Snellen lines) as compared to baseline, patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.
arm group label: Glanatec(R) 3 times a day
arm group type: Active Comparator
arm group label: Glanatec (R) 6 times a day
arm group type: Active Comparator
intervention type: Drug
intervention name: Ripasudil hydrochloride hydrate 0.4% ophthalmic solution
description: the ophthalmic solution will be administered three or six per times per day in the eye designated as the "Study Eye" upon study enrollment
arm group label: Glanatec (R) 6 times a day
arm group label: Glanatec(R) 3 times a day
other name: Glanatec
criteria: 
gender: All
minimum age: 18 Years
maximum age: 91 Years
healthy volunteers: No
last name: Duanny Alva, MPH
phone: 847-570-1783
email: dalva@northshore.org
last name: Marian Macsai, MD
phone: 847-657-1936
email: mmacsai@northshore.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: NorthShore University HealthSystem
investigator full name: Marian Macsai, MD
investigator title: Chief Ophthalmology
mesh term: Fuchs' Endothelial Dystrophy
mesh term: Ophthalmic Solutions
sharing ipd: No
submitted: May 11, 2023
returned: June 9, 2023