<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/NCT03237936</url>
  </required_header>
  <id_info>
    <org_study_id>NVG16E128</org_study_id>
    <nct_id>NCT03237936</nct_id>
  </id_info>
  <brief_title>Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis</brief_title>
  <official_title>A Phase IV, Prospective, Open-label, Multicentre, Single Arm, 3-month Proof of Concept Study to Assess the Effect of IKERVIS® Eye Drops Administered Once Daily on the Quality of Vision in Dry Eye Disease (DED) Patients With Severe Keratitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Santen SAS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Santen SAS</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>
      The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of&#xD;
      concept study. The study is designed to assess the effect on the quality of vision of&#xD;
      IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED)&#xD;
      patients with severe keratitis, as well as its safety and efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this phase IV clinical trial the Month 3 visit assessments will be used to assess the&#xD;
      efficacy (quality of vision and other parameters) and safety of IKERVIS® in DED patients with&#xD;
      severe keratitis.&#xD;
&#xD;
      To assess the effect on the quality of vision of IKERVIS® (1mg/ml ciclosporin) eye drops&#xD;
      administered once daily in adult dry eye disease (DED) patients with severe keratitis over 3&#xD;
      months of treatment.&#xD;
&#xD;
      To assess the safety of DED patients with severe keratitis treated with IKERVIS® (1mg/mL&#xD;
      ciclosporin) for 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 28, 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between the change from baseline in quality of vision and the change from baseline in Corneal Fluorescein Staining (CFS)</measure>
    <time_frame>at month 3</time_frame>
    <description>CFS test can detect damage to the cornea.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">33</enrollment>
  <condition>Keratitis</condition>
  <arm_group>
    <arm_group_label>IKERVIS® (1mg/mL ciclosporin) eye drops</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one drop of study medication (IKERVIS®1mg/mL) once daily in each eye at bedtime during 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1mg/mL ciclosporin</intervention_name>
    <description>IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment</description>
    <arm_group_label>IKERVIS® (1mg/mL ciclosporin) eye drops</arm_group_label>
    <other_name>IKERVIS®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient eligibility is determined according to the following criteria:&#xD;
&#xD;
               1. In the opinion of the investigator, the patient is capable of understanding and&#xD;
                  complying with protocol requirements.&#xD;
&#xD;
               2. The patient signs and dates a written, informed consent form and any required&#xD;
                  privacy authorization prior to the initiation of any study procedures&#xD;
&#xD;
               3. Male or female patient is aged 18 years or above.&#xD;
&#xD;
               4. DED patients with persistent severe keratitis at the Screening and&#xD;
&#xD;
                  Baseline Visits defined as the following:&#xD;
&#xD;
                  • CFS score of 3, 4 or 5 on the modified Oxford scale&#xD;
&#xD;
               5. Patient must be willing and able to undergo and return for scheduled&#xD;
                  study-related examinations.&#xD;
&#xD;
               6. The same eye (eligible eye) should fulfill all the above criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of ocular trauma or ocular infection (viral, bacterial, fungal,&#xD;
             protozoal) within 90 days before the Screening Visit and any ocular diseases other&#xD;
             than dry eye disease requiring topical ocular treatment during the course of the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre-Jean PISELLA</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Bretonneau</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elsa LLOBET-MERKLING</last_name>
    <phone>0613861174</phone>
    <email>e.llobetmerkling@euraxipharma.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Béatrice COCHENER, MD</last_name>
    </contact>
    <investigator>
      <last_name>Pierre-Jean PISELLA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>October 9, 2017</last_update_submitted>
  <last_update_submitted_qc>October 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
    <mesh_term>Keratitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclosporine</mesh_term>
    <mesh_term>Cyclosporins</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/NCT03237936
org study id: NVG16E128
nct id: NCT03237936
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of
      concept study. The study is designed to assess the effect on the quality of vision of
      IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED)
      patients with severe keratitis, as well as its safety and efficacy.
In this phase IV clinical trial the Month 3 visit assessments will be used to assess the
      efficacy (quality of vision and other parameters) and safety of IKERVIS® in DED patients with
      severe keratitis.

      To assess the effect on the quality of vision of IKERVIS® (1mg/ml ciclosporin) eye drops
      administered once daily in adult dry eye disease (DED) patients with severe keratitis over 3
      months of treatment.

      To assess the safety of DED patients with severe keratitis treated with IKERVIS® (1mg/mL
      ciclosporin) for 3 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Correlation between the change from baseline in quality of vision and the change from baseline in Corneal Fluorescein Staining (CFS)
time frame: at month 3
description: CFS test can detect damage to the cornea.
arm group label: IKERVIS® (1mg/mL ciclosporin) eye drops
arm group type: Experimental
description: one drop of study medication (IKERVIS®1mg/mL) once daily in each eye at bedtime during 3 months.
intervention type: Drug
intervention name: 1mg/mL ciclosporin
description: IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment
arm group label: IKERVIS® (1mg/mL ciclosporin) eye drops
other name: IKERVIS®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Pierre-Jean PISELLA
role: Principal Investigator
affiliation: CHU Bretonneau
last name: Elsa LLOBET-MERKLING
phone: 0613861174
email: e.llobetmerkling@euraxipharma.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Eye Diseases
mesh term: Keratitis
mesh term: Cyclosporine
mesh term: Cyclosporins
sharing ipd: No