<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/NCT04451239</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-19 keratoconjunctivitis</org_study_id>
    <nct_id>NCT04451239</nct_id>
  </id_info>
  <brief_title>Topical Steroids and Cyclosporin-A for COVID-19 Keratoconjunctivitis</brief_title>
  <official_title>Combined Topical Corticosteroid and Topical Cyclosporine-A for Management of COVID-19 Keratoconjunctivitis; a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ameera Gamal Abdelhameed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Kuwait</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore the feasibility of combined topical corticosteroid and topical cyclosporine-A in&#xD;
      COVID-19 patients with acute keratoconjunctivitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 patients presenting with acute keratoconjunctivitis will be treated with Topical 1%&#xD;
      prednisolone acetate fourTimes daily for 7 days as initial treatment, non-preserved&#xD;
      artificial tears four times daily and cyclosporin A 0.5% four times daily .&#xD;
&#xD;
      Twelve patients with COVID-19 Keratoconjunctivitis will be enrolled in this open-label study.&#xD;
      Symptoms and findings of the patients before and after treatment were recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 30, 2020</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom improvement</measure>
    <time_frame>10-15 days</time_frame>
    <description>eye itching, foreign body sensation, tearing, redness in the eye and eyelid swelling</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Signs improvement</measure>
    <time_frame>10-15 days</time_frame>
    <description>conjunctival injection, discharge, presence of superficial punctate keratitis (SPK), pseudomembranes on tarsal conjunctiva</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Keratonjunctivitis</condition>
  <arm_group>
    <arm_group_label>COVID-19 keratoconjunctivitis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>cases will receive topical 1% prednisolone acetate for 7 days as initial treatment +non-preserved artificial tears and cyclosporin A 0.5% four times daily .</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>topical steroids and cyclosporin-A</intervention_name>
    <description>All patient will be treated with Topical 1% prednisolone acetate for 7 days as initial treatment +non-preserved artificial tears and cyclosporin A 0.5% four times daily .</description>
    <arm_group_label>COVID-19 keratoconjunctivitis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID-19 Patients with keratoconjunctivitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  associated ocular pathology or disease&#xD;
&#xD;
          -  other causes of keratoconjunctivitis for example allergic or herpetic&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mona Nasseif, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tanta University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ameera Abdelhameed, MD</last_name>
    <phone>01120090000</phone>
    <email>amiragamal287@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Farawanyia hospital</name>
      <address>
        <city>Kuwait</city>
        <state>Farawanyia</state>
        <country>Kuwait</country>
      </address>
    </facility>
    <contact>
      <last_name>Mona Nasseif, MD</last_name>
      <phone>96566578919</phone>
      <email>Monanasseif@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Kuwait</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Ameera Gamal Abdelhameed</investigator_full_name>
    <investigator_title>Lecturer of Ophthalmology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratoconjunctivitis</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/NCT04451239
org study id: COVID-19 keratoconjunctivitis
nct id: NCT04451239
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
To explore the feasibility of combined topical corticosteroid and topical cyclosporine-A in
      COVID-19 patients with acute keratoconjunctivitis.
COVID-19 patients presenting with acute keratoconjunctivitis will be treated with Topical 1%
      prednisolone acetate fourTimes daily for 7 days as initial treatment, non-preserved
      artificial tears four times daily and cyclosporin A 0.5% four times daily .

      Twelve patients with COVID-19 Keratoconjunctivitis will be enrolled in this open-label study.
      Symptoms and findings of the patients before and after treatment were recorded.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Symptom improvement
time frame: 10-15 days
description: eye itching, foreign body sensation, tearing, redness in the eye and eyelid swelling
measure: Signs improvement
time frame: 10-15 days
description: conjunctival injection, discharge, presence of superficial punctate keratitis (SPK), pseudomembranes on tarsal conjunctiva
arm group label: COVID-19 keratoconjunctivitis
arm group type: Other
description: cases will receive topical 1% prednisolone acetate for 7 days as initial treatment +non-preserved artificial tears and cyclosporin A 0.5% four times daily .
intervention type: Drug
intervention name: topical steroids and cyclosporin-A
description: All patient will be treated with Topical 1% prednisolone acetate for 7 days as initial treatment +non-preserved artificial tears and cyclosporin A 0.5% four times daily .
arm group label: COVID-19 keratoconjunctivitis
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mona Nasseif, MD
role: Principal Investigator
affiliation: Tanta University
last name: Ameera Abdelhameed, MD
phone: 01120090000
email: amiragamal287@gmail.com
facility: 
contact: 
country: Kuwait
responsible party type: Sponsor-Investigator
investigator affiliation: Mansoura University
investigator full name: Ameera Gamal Abdelhameed
investigator title: Lecturer of Ophthalmology
mesh term: Keratoconjunctivitis
mesh term: Cyclosporine
mesh term: Cyclosporins
sharing ipd: No