<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/NCT03758859</url>
  </required_header>
  <id_info>
    <org_study_id>18SM4868</org_study_id>
    <nct_id>NCT03758859</nct_id>
  </id_info>
  <brief_title>CLARITY Imaging Study</brief_title>
  <acronym>CLARITY</acronym>
  <official_title>CLARITY Imaging Study: The Effect Of Cross-linked Sodium Hyaluronate On The Quality Of Optical Coherence Tomography Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</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>
      OCT image quality is necessary to provide accurate diagnostic information to&#xD;
      ophthalmologists. The increasing resolution of imaging techniques will require ever more high&#xD;
      standards of optical transmission through the cornea and tear film. Given that lubricant&#xD;
      drops can improve optical transmission through the cornea, this study will attempt to&#xD;
      quantify this. The primary objective is to assess the effect of cross-linked sodium&#xD;
      hyaluronate on OCT image quality compared to the effect of blinking alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 12, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2019</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Randomisation is between eyes i.e. eye exposed to blinking alone vs eye exposed to lubricant drops</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clarity of retinal images obtained by Optical Coherence Tomography.</measure>
    <time_frame>immediately after the administration of drops.</time_frame>
    <description>Signal strength of OCT scan</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>sodium hyaluronate eye drops</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the randomly allocated eye will receive sodium hyaluronate drops, followed by a repeat OCT scan; images are then evaluated for clarity by the masked assessor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sodium hyaluronate eyedrops</intervention_name>
    <description>sodium hyaluronate eyedrops administered - route ocular -topical</description>
    <arm_group_label>sodium hyaluronate eye drops</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients subjectively deemed to have poor image quality by the photographer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a known adverse reaction to any of the constituents of the XLHA&#xD;
&#xD;
          -  Patients wearing contact lenses&#xD;
&#xD;
          -  Patients who have used eyedrops in the past 2 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Timothy Yap</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College NHS Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Serge Miodragovic</last_name>
    <phone>+442033123206</phone>
    <phone_ext>23206</phone_ext>
    <email>serge.miodragovic1@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Timothy Yap</last_name>
    <phone>+442033123206</phone>
    <phone_ext>23206</phone_ext>
    <email>timothyedward.yap@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Western Eye Hospital</name>
      <address>
        <city>London</city>
        <zip>NW1 5QH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Serge Miodragovic</last_name>
      <phone>+44 2033123206</phone>
      <phone_ext>23206</phone_ext>
      <email>serge.miodragovic1@nhs.net</email>
    </contact>
    <contact_backup>
      <last_name>Timothy Yap</last_name>
      <phone>+44 2033123206</phone>
      <phone_ext>23206</phone_ext>
      <email>timothyedward.yap@nhs.net</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>September 2, 2019</last_update_submitted>
  <last_update_submitted_qc>September 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03758859
org study id: 18SM4868
nct id: NCT03758859
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
OCT image quality is necessary to provide accurate diagnostic information to
      ophthalmologists. The increasing resolution of imaging techniques will require ever more high
      standards of optical transmission through the cornea and tear film. Given that lubricant
      drops can improve optical transmission through the cornea, this study will attempt to
      quantify this. The primary objective is to assess the effect of cross-linked sodium
      hyaluronate on OCT image quality compared to the effect of blinking alone.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
masking description: Randomisation is between eyes i.e. eye exposed to blinking alone vs eye exposed to lubricant drops
measure: Clarity of retinal images obtained by Optical Coherence Tomography.
time frame: immediately after the administration of drops.
description: Signal strength of OCT scan
arm group label: sodium hyaluronate eye drops
arm group type: Experimental
description: the randomly allocated eye will receive sodium hyaluronate drops, followed by a repeat OCT scan; images are then evaluated for clarity by the masked assessor.
intervention type: Other
intervention name: sodium hyaluronate eyedrops
description: sodium hyaluronate eyedrops administered - route ocular -topical
arm group label: sodium hyaluronate eye drops
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Timothy Yap
role: Principal Investigator
affiliation: Imperial College NHS Trust
last name: Serge Miodragovic
phone: +442033123206
phone ext: 23206
email: serge.miodragovic1@nhs.net
last name: Timothy Yap
phone: +442033123206
phone ext: 23206
email: timothyedward.yap@nhs.net
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Glaucoma
mesh term: Ophthalmic Solutions
mesh term: Hyaluronic Acid
sharing ipd: Undecided