<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/NCT03812952</url>
  </required_header>
  <id_info>
    <org_study_id>Xiaofeng Lin</org_study_id>
    <nct_id>NCT03812952</nct_id>
  </id_info>
  <brief_title>China Red Eye Study on Allergic Conjunctivitis</brief_title>
  <official_title>Current Status of Diagnosis and Treatment of Allergic Conjunctivitis in Chinese Ophthalmology Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen 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>
      This study is the first multi-center cross-sectional study on the diagnosis and misdiagnosis&#xD;
      of allergic conjunctivitis in the ophthalmology clinic in China. It provides a clinical basis&#xD;
      for the standardized diagnosis and treatment of allergic eye diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Allergic conjunctivitis is a common disease in ophthalmology. The European Allergy&#xD;
      Association, Japan, the United States and other countries have clear diagnostic criteria or&#xD;
      guidelines for the definition and diagnosis of allergic diseases and allergic conjunctivitis.&#xD;
      However, China is currently lacking related guidelines. Allergic conjunctivitis has some of&#xD;
      the same symptoms and signs as other infections/non-infectious conjunctival inflammation.&#xD;
      When the symptoms and signs are atypical, it is prone to missed diagnosis and misdiagnosis,&#xD;
      resulting in prolonged disease duration, drug abuse and waste of medical resources.&#xD;
&#xD;
      The current abuse of antibiotics is considered to be a huge problem in the treatment of&#xD;
      ocular surface diseases. A study in our country believes that the rate of misdiagnosis of dry&#xD;
      eye is as high as 66.2%, and most of them are misdiagnosed as chronic conjunctivitis,&#xD;
      resulting in frequent using a variety of antibiotic eye drops. At present, the misdiagnosis&#xD;
      of allergic conjunctivitis and the abuse of antibiotics caused by misdiagnosis in China are&#xD;
      still unclear, therefore clinical research is urgently needed. We intend to use this study to&#xD;
      understand the status of diagnosis and treatment of allergic conjunctivitis in China, and&#xD;
      provide clinical evidence for the standard diagnosis and treatment of allergic eye diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Specific diagnosis of the patients</measure>
    <time_frame>Until the study completion, up to 1 year</time_frame>
    <description>the investigators record the patients' specific diagnosis (such as seasonal allergic conjunctivitis, perennial allergic conjunctivitis, vernal keratoconjunctivitis，and etc) on questionnaire when the patient come</description>
  </primary_outcome>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Allergic Conjunctivitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients whose clinical diagnosis is allergic conjunctivitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients whose clinical diagnosis is allergic conjunctivitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The investigator believes that there are any unsuitable reasons for participating in&#xD;
             the trial.&#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>Xiaofeng Lin</last_name>
    <role>Study Chair</role>
    <affiliation>Zhongshan Ophthalmic Center, Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center of Sun yat-sen Universtiy</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 20, 2019</last_update_submitted>
  <last_update_submitted_qc>January 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Xiaofeng Lin</investigator_full_name>
    <investigator_title>associate dean of Zhongshan Ophthalmic Center, Sun Yat-sen University</investigator_title>
  </responsible_party>
  <keyword>misdiagnose</keyword>
  <keyword>mistreatment</keyword>
  <keyword>antibiotics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Conjunctivitis</mesh_term>
    <mesh_term>Conjunctivitis, Allergic</mesh_term>
  </condition_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/NCT03812952
org study id: Xiaofeng Lin
nct id: NCT03812952
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is the first multi-center cross-sectional study on the diagnosis and misdiagnosis
      of allergic conjunctivitis in the ophthalmology clinic in China. It provides a clinical basis
      for the standardized diagnosis and treatment of allergic eye diseases.
Allergic conjunctivitis is a common disease in ophthalmology. The European Allergy
      Association, Japan, the United States and other countries have clear diagnostic criteria or
      guidelines for the definition and diagnosis of allergic diseases and allergic conjunctivitis.
      However, China is currently lacking related guidelines. Allergic conjunctivitis has some of
      the same symptoms and signs as other infections/non-infectious conjunctival inflammation.
      When the symptoms and signs are atypical, it is prone to missed diagnosis and misdiagnosis,
      resulting in prolonged disease duration, drug abuse and waste of medical resources.

      The current abuse of antibiotics is considered to be a huge problem in the treatment of
      ocular surface diseases. A study in our country believes that the rate of misdiagnosis of dry
      eye is as high as 66.2%, and most of them are misdiagnosed as chronic conjunctivitis,
      resulting in frequent using a variety of antibiotic eye drops. At present, the misdiagnosis
      of allergic conjunctivitis and the abuse of antibiotics caused by misdiagnosis in China are
      still unclear, therefore clinical research is urgently needed. We intend to use this study to
      understand the status of diagnosis and treatment of allergic conjunctivitis in China, and
      provide clinical evidence for the standard diagnosis and treatment of allergic eye diseases.
observational model: Other
time perspective: Retrospective
measure: Specific diagnosis of the patients
time frame: Until the study completion, up to 1 year
description: the investigators record the patients' specific diagnosis (such as seasonal allergic conjunctivitis, perennial allergic conjunctivitis, vernal keratoconjunctivitis，and etc) on questionnaire when the patient come
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Xiaofeng Lin
role: Study Chair
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Xiaofeng Lin
investigator title: associate dean of Zhongshan Ophthalmic Center, Sun Yat-sen University
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic
sharing ipd: No