xml: <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/NCT06017362</url>
    </required_header>
    <id_info>
      <org_study_id>22/457-EC_M</org_study_id>
      <nct_id>NCT06017362</nct_id>
    </id_info>
    <brief_title>Clinical Trial To Determine The Efficacy And Safety Of Insulin Eye Drops In Dry Eye In Patients With Topical Hypotensors</brief_title>
    <official_title>Ensayo clínico Para Determinar la Eficacia y Seguridad Del Colirio de Insulina en el Tratamiento Del Ojo Seco en Pacientes Con Hipotensores tópicos</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Barbara Burgos Blasco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital San Carlos, Madrid</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to evaluate the preliminary efficacy of the use of insulin&#xD;
        eye drops in the control of dry eye disease in patients with topical hypotensors, compared to&#xD;
        placebo (artificial tears).&#xD;
  &#xD;
        The main question aims to answer whether glaucoma patients treated with topical hypotensors&#xD;
        could benefit from the use of insulin eye drops for the treatment of dry eye.&#xD;
  &#xD;
        Participants will be assigned to one of the two treatment arms and will be required to attend&#xD;
        four follow-up visits (baseline, 1, 3, and 6 months).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients will be recruited in Madrid. Patients with dry eye disease and topical glaucoma&#xD;
        treatment will be identified through the Ophthalmology clinic. They will be directly referred&#xD;
        to a physician who is participating in this study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 8, 2023</start_date>
    <completion_date type="Anticipated">February 8, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 8, 2025</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in dry eye symptoms from baseline to 6 months after treatment time</measure>
      <time_frame>From baseline to 6 months after treatment</time_frame>
      <description>Dry eye symptoms will be evaluated using OSDI</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change of corneal staining from baseline to 6 months after treatment</measure>
      <time_frame>From baseline to 6 months after treatment</time_frame>
      <description>Corneal staining will be evaluated on the slit-lamp and on slit-lamp images</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in corneal aesthesiometry from baseline to 6 months after treatment</measure>
      <time_frame>From baseline to 6 months after treatment</time_frame>
      <description>Aesthesiometry will be evaluated using Cochet Bonnet</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in conjunctival hyperemia from baseline to 6 months after treatment</measure>
      <time_frame>From baseline to 6 months after treatment</time_frame>
      <description>Conjunctival hyperemia will be evaluated using Keratograph</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in non-invasive tear film break-up time from baseline to 6 months after treatment</measure>
      <time_frame>From baseline to 6 months after treatment</time_frame>
      <description>Non-invasive tear film break-up time will be evaluated using Keratograph</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in light dispersion from baseline to 6 months after treatment</measure>
      <time_frame>From baseline to 6 months after treatment</time_frame>
      <description>Light dispersion will be evaluated using the Optical Quality Analysis System</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in cytokine levels from baseline to 6 months after treatment</measure>
      <time_frame>From baseline to 6 months after treatment</time_frame>
      <description>Cytokine leves will be evaluated using immunoassay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in therapeutic compliance from baseline to 6 months after treatment</measure>
      <time_frame>From baseline to 6 months after treatment</time_frame>
      <description>Therapeutic compliance will be evaluated using Medication adherence rating scale (MARS). The total score ranges from 0-10 with a higher score indicating better adherence.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Dry Eye</condition>
    <condition>Glaucoma</condition>
    <arm_group>
      <arm_group_label>Insulin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Topical insulin 1UI/ml 4 times a day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo (artificial tears)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Artificial tears 4 times a day</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Insulin</intervention_name>
      <description>Topical insulin 1UI/ml 4 times a day</description>
      <arm_group_label>Insulin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Artificial tear</intervention_name>
      <description>Artificial tears 4 times a day</description>
      <arm_group_label>Placebo (artificial tears)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who provide written informed consent and who are able and willing to comply&#xD;
               with all scheduled study visits and procedures.&#xD;
  &#xD;
            -  Patients ≥ 18 years at the screening visit.&#xD;
  &#xD;
            -  Ocular hypertension or glaucoma controlled with hypotensive treatment&#xD;
  &#xD;
            -  Diagnosis of dry eye&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next&#xD;
               6 months&#xD;
  &#xD;
            -  Changes in topical glaucoma treatment in the last 3 months&#xD;
  &#xD;
            -  Severe dry eye requiring immediate treatment&#xD;
  &#xD;
            -  Previous eye surgery, except cataract surgery more than 12 months ago&#xD;
  &#xD;
            -  Laser procedures less than 6 months ago&#xD;
  &#xD;
            -  Other concomitant ocular pathology: scarring disease of the ocular surface, uveitis,&#xD;
               infection in the last 90 days, trauma in the last 90 days&#xD;
  &#xD;
            -  Eyelid disorders&#xD;
  &#xD;
            -  Use of contact lenses&#xD;
  &#xD;
            -  Other topical treatment other than dry eye and glaucoma&#xD;
  &#xD;
            -  Patients with a history of allergy or hypersensitivity to the study medication or any&#xD;
               of its excipients&#xD;
  &#xD;
            -  Modifications in systemic immunosuppressive treatment in the last 6 months&#xD;
  &#xD;
            -  History of alcohol or drug abuse&#xD;
  &#xD;
            -  Patients who have received an experimental drug or used an experimental medical device&#xD;
               in the 30-day period prior to the screening visit.&#xD;
  &#xD;
            -  Systemic pathology (cardiopulmonary pathology, connective tissue disorders,&#xD;
               neurological or psychiatric pathology) or situation of the patient that does not allow&#xD;
               examination (such as mental or psychomotor retardation).&#xD;
  &#xD;
            -  Any other disease or condition that, at the discretion of the investigator, could&#xD;
               constitute a risk to the participant or interfere with the results of the study.&#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>Barbara Burgos Blasco, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital Clinico San Carlos</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Barbara Burgos Blasco, MD, PhD</last_name>
      <phone>+34 913303000</phone>
      <phone_ext>3132</phone_ext>
      <email>bburgos171@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Clinico San Carlos</name>
        <address>
          <city>Madrid</city>
          <zip>28040</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Barbara Burgos Blasco</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Hospital San Carlos, Madrid</investigator_affiliation>
      <investigator_full_name>Barbara Burgos Blasco</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dry Eye Syndromes</mesh_term>
      <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lubricant Eye Drops</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017362
  org study id: 22/457-EC_M
  nct id: NCT06017362
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to evaluate the preliminary efficacy of the use of insulin
        eye drops in the control of dry eye disease in patients with topical hypotensors, compared to
        placebo (artificial tears).
  
        The main question aims to answer whether glaucoma patients treated with topical hypotensors
        could benefit from the use of insulin eye drops for the treatment of dry eye.
  
        Participants will be assigned to one of the two treatment arms and will be required to attend
        four follow-up visits (baseline, 1, 3, and 6 months).
  Patients will be recruited in Madrid. Patients with dry eye disease and topical glaucoma
        treatment will be identified through the Ophthalmology clinic. They will be directly referred
        to a physician who is participating in this study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Changes in dry eye symptoms from baseline to 6 months after treatment time
  time frame: From baseline to 6 months after treatment
  description: Dry eye symptoms will be evaluated using OSDI
  measure: Change of corneal staining from baseline to 6 months after treatment
  time frame: From baseline to 6 months after treatment
  description: Corneal staining will be evaluated on the slit-lamp and on slit-lamp images
  measure: Change in corneal aesthesiometry from baseline to 6 months after treatment
  time frame: From baseline to 6 months after treatment
  description: Aesthesiometry will be evaluated using Cochet Bonnet
  measure: Change in conjunctival hyperemia from baseline to 6 months after treatment
  time frame: From baseline to 6 months after treatment
  description: Conjunctival hyperemia will be evaluated using Keratograph
  measure: Change in non-invasive tear film break-up time from baseline to 6 months after treatment
  time frame: From baseline to 6 months after treatment
  description: Non-invasive tear film break-up time will be evaluated using Keratograph
  measure: Change in light dispersion from baseline to 6 months after treatment
  time frame: From baseline to 6 months after treatment
  description: Light dispersion will be evaluated using the Optical Quality Analysis System
  measure: Change in cytokine levels from baseline to 6 months after treatment
  time frame: From baseline to 6 months after treatment
  description: Cytokine leves will be evaluated using immunoassay
  measure: Change in therapeutic compliance from baseline to 6 months after treatment
  time frame: From baseline to 6 months after treatment
  description: Therapeutic compliance will be evaluated using Medication adherence rating scale (MARS). The total score ranges from 0-10 with a higher score indicating better adherence.
  arm group label: Insulin
  arm group type: Experimental
  description: Topical insulin 1UI/ml 4 times a day
  arm group label: Placebo (artificial tears)
  arm group type: Placebo Comparator
  description: Artificial tears 4 times a day
  intervention type: Drug
  intervention name: Insulin
  description: Topical insulin 1UI/ml 4 times a day
  arm group label: Insulin
  intervention type: Drug
  intervention name: Artificial tear
  description: Artificial tears 4 times a day
  arm group label: Placebo (artificial tears)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Barbara Burgos Blasco, MD, PhD
  role: Principal Investigator
  affiliation: Hospital Clinico San Carlos
  last name: Barbara Burgos Blasco, MD, PhD
  phone: +34 913303000
  phone ext: 3132
  email: bburgos171@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Spain
  responsible party type: Sponsor-Investigator
  investigator affiliation: Hospital San Carlos, Madrid
  investigator full name: Barbara Burgos Blasco
  investigator title: Principal Investigator
  mesh term: Dry Eye Syndromes
  mesh term: Keratoconjunctivitis Sicca
  mesh term: Lubricant Eye Drops
  sharing ipd: No