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/NCT05962528</url>
    </required_header>
    <id_info>
      <org_study_id>KY2023024</org_study_id>
      <nct_id>NCT05962528</nct_id>
    </id_info>
    <brief_title>Soft Contact Lens Fitting With Different Sagittal Height</brief_title>
    <official_title>Soft Contact Lens Fitting With Different Sagittal Height</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Eye Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Eye Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        To evaluate whether there is a difference in subjective and objective fit of soft lenses with&#xD;
        different sagittal height&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Actual">July 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Subjective questionnaire</measure>
      <time_frame>1 day (Once time after wearing the soft lens)</time_frame>
      <description>The subjective questionnaire is a visual quality questionnaire developed by combining previous research and clinical symptoms, including whether there is foreign body sensation, pain, dry eyes, etc.The score ranges from 0 to 4, with the higher the score, the more obvious the symptoms</description>
    </primary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Myopia</condition>
    <arm_group>
      <arm_group_label>Type 1 group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Toric soft lens with high sagittal height</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Type 2 group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Toric soft lens with low sagittal height</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Type 3 group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Spherical soft lens with high sagittal height</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Type 4 group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Spherical soft lens with low sagittal height</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Traditional spherical soft lens</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Soft lens</intervention_name>
      <description>Patients were randomly fitted with five different designs of soft lenses</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Type 1 group</arm_group_label>
      <arm_group_label>Type 2 group</arm_group_label>
      <arm_group_label>Type 3 group</arm_group_label>
      <arm_group_label>Type 4 group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age more than 18 years&#xD;
  &#xD;
            -  No active eye disease&#xD;
  &#xD;
            -  5 soft lenses for the experiment can be successfully worn and all examinations can be&#xD;
               completed as required&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active eye disease&#xD;
  &#xD;
            -  BCVA less than 20/25&#xD;
  &#xD;
            -  Those who are too small or tight eyelids are not suitable for wearing soft lenses&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Tiejing Sun, MD</last_name>
      <phone>+8627306525</phone>
      <email>suntiejing0109@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tianjin Eye Hospital</name>
        <address>
          <city>Tianjin</city>
          <zip>300020</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tiejing Sun, MD</last_name>
        <phone>+8627306525</phone>
        <email>suntiejing0109@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</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>Seizures</mesh_term>
      <mesh_term>Myopia</mesh_term>
    </condition_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/NCT05962528
  org study id: KY2023024
  nct id: NCT05962528
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate whether there is a difference in subjective and objective fit of soft lenses with
        different sagittal height
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: Subjective questionnaire
  time frame: 1 day (Once time after wearing the soft lens)
  description: The subjective questionnaire is a visual quality questionnaire developed by combining previous research and clinical symptoms, including whether there is foreign body sensation, pain, dry eyes, etc.The score ranges from 0 to 4, with the higher the score, the more obvious the symptoms
  arm group label: Type 1 group
  arm group type: Experimental
  description: Toric soft lens with high sagittal height
  arm group label: Type 2 group
  arm group type: Experimental
  description: Toric soft lens with low sagittal height
  arm group label: Type 3 group
  arm group type: Experimental
  description: Spherical soft lens with high sagittal height
  arm group label: Type 4 group
  arm group type: Experimental
  description: Spherical soft lens with low sagittal height
  arm group label: Control group
  arm group type: Placebo Comparator
  description: Traditional spherical soft lens
  intervention type: Device
  intervention name: Soft lens
  description: Patients were randomly fitted with five different designs of soft lenses
  arm group label: Control group
  arm group label: Type 1 group
  arm group label: Type 2 group
  arm group label: Type 3 group
  arm group label: Type 4 group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tiejing Sun, MD
  phone: +8627306525
  email: suntiejing0109@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Seizures
  mesh term: Myopia
  sharing ipd: No