<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/NCT03000556</url>
  </required_header>
  <id_info>
    <org_study_id>AL-2016-DF</org_study_id>
    <nct_id>NCT03000556</nct_id>
  </id_info>
  <brief_title>0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation</brief_title>
  <official_title>0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation After Corneal Abrasions: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fang Duan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about&#xD;
      10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in&#xD;
      Zhongshan Ophthalmic Center. Clinical emergency treatment of TCA is relatively simple and&#xD;
      effective, corneal epithelial damage can be recovered within 48 hours. However, about 25% TCA&#xD;
      would be developed to the recurrence of exfoliation. Once the recurrence of TCA, the&#xD;
      treatment would be more difficult and even cause blindness. Therefore, it is of great&#xD;
      practical significance to prevent the recurrence of TCA. However, there is no effective&#xD;
      methods to prevent recurrence of TCA.&#xD;
&#xD;
      0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and promote&#xD;
      repair of corneal epithelium. On this basis, the investigators hypotheses that 0.3% sodium&#xD;
      hyaluronate eye drops can prevent the recurrence of TCA. So, investigators intend to test&#xD;
      effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of TCA by a&#xD;
      prospective, single center, randomized, controlled pilot study. In this study, 60 patients&#xD;
      with TCA were randomly divided into control group and sodium hyaluronate treatment group and&#xD;
      observed one year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the incidence of recurrent corneal epithelium exfoliation</measure>
    <time_frame>6 month</time_frame>
    <description>Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the incidence of recurrent corneal epithelium exfoliation</measure>
    <time_frame>1 year</time_frame>
    <description>Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>corneal fluorescein staining score</measure>
    <time_frame>1 year</time_frame>
    <description>Grading of corneal epithelial fluorescein sodium staining under slit lamp. The average cornea was divided into four quadrants and scored separately, adding all the scores to get the final score. Scoring criteria: 0 point: no staining; 1 point: punctate staining less than 30 dots; 2 points: punctate staining more than 30 dots, more than the point of the color but not scattered; 3 points: severe dispersion staining but no plaque staining; 4 points: plaque staining. Maximum score of 16 points per eye.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal edema grading</measure>
    <time_frame>1 year</time_frame>
    <description>Grading of corneal edema under slit lamp. 0 point: C、corneal transparency without edema; 1 point: corneal haze edema, corneal endothelium smooth, iris texture is clearly visible; 2 points: corneal surface roughness, iris texture fuzzy; 3 points: corneal endothelial surface cracking, iris texture as is not clear; 4 points: white corneal edema, intraocular structure as unclear.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Corneal Epithelium Exfoliation</condition>
  <arm_group>
    <arm_group_label>experience</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.3% Sodium Hyaluronate Eye Drop</intervention_name>
    <description>The patients need to use 0.3% Sodium Hyaluronate Eye Drop for 3 month.</description>
    <arm_group_label>experience</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Definitive diagnosis of primary corneal epithelial abrasion;&#xD;
&#xD;
          -  Monocular onset;&#xD;
&#xD;
          -  Corneal epithelium was defected and fluorescein sodium staining was positive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Corneal epithelial defect complicated with infection&#xD;
&#xD;
          -  Associated with other ocular surface disease patients (such as hypophasis, meibomian&#xD;
             gland dysfunction, keratoconjunctivitis sicca syndrome, bullous keratopathy, corneal&#xD;
             dystrophy and drug-induced corneal toxicity etc.)&#xD;
&#xD;
          -  Pregnant or lactating women; serious heart, liver, and kidney dysfunction; mental&#xD;
             disorders; other inflammatory or autoimmune diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fang Duan, doctor</last_name>
    <phone>8613710790313</phone>
    <email>duanfangg@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongshan ophthalmic center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fang Duan</last_name>
      <phone>86-20-87331537</phone>
      <email>duanfangg@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhaohui Yuan</last_name>
      <phone>86-20-87331537</phone>
      <email>zhaohui1208@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Fang Duan</investigator_full_name>
    <investigator_title>clinical professor</investigator_title>
  </responsible_party>
  <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>Yes</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/NCT03000556
org study id: AL-2016-DF
nct id: NCT03000556
lead sponsor: 
has dmc: Yes
Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about
      10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in
      Zhongshan Ophthalmic Center. Clinical emergency treatment of TCA is relatively simple and
      effective, corneal epithelial damage can be recovered within 48 hours. However, about 25% TCA
      would be developed to the recurrence of exfoliation. Once the recurrence of TCA, the
      treatment would be more difficult and even cause blindness. Therefore, it is of great
      practical significance to prevent the recurrence of TCA. However, there is no effective
      methods to prevent recurrence of TCA.

      0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and promote
      repair of corneal epithelium. On this basis, the investigators hypotheses that 0.3% sodium
      hyaluronate eye drops can prevent the recurrence of TCA. So, investigators intend to test
      effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of TCA by a
      prospective, single center, randomized, controlled pilot study. In this study, 60 patients
      with TCA were randomly divided into control group and sodium hyaluronate treatment group and
      observed one year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: the incidence of recurrent corneal epithelium exfoliation
time frame: 6 month
description: Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.
measure: the incidence of recurrent corneal epithelium exfoliation
time frame: 1 year
description: Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.
measure: corneal fluorescein staining score
time frame: 1 year
description: Grading of corneal epithelial fluorescein sodium staining under slit lamp. The average cornea was divided into four quadrants and scored separately, adding all the scores to get the final score. Scoring criteria: 0 point: no staining; 1 point: punctate staining less than 30 dots; 2 points: punctate staining more than 30 dots, more than the point of the color but not scattered; 3 points: severe dispersion staining but no plaque staining; 4 points: plaque staining. Maximum score of 16 points per eye.
measure: Corneal edema grading
time frame: 1 year
description: Grading of corneal edema under slit lamp. 0 point: C、corneal transparency without edema; 1 point: corneal haze edema, corneal endothelium smooth, iris texture is clearly visible; 2 points: corneal surface roughness, iris texture fuzzy; 3 points: corneal endothelial surface cracking, iris texture as is not clear; 4 points: white corneal edema, intraocular structure as unclear.
arm group label: experience
arm group type: Experimental
arm group label: control
arm group type: No Intervention
intervention type: Drug
intervention name: 0.3% Sodium Hyaluronate Eye Drop
description: The patients need to use 0.3% Sodium Hyaluronate Eye Drop for 3 month.
arm group label: experience
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Fang Duan, doctor
phone: 8613710790313
email: duanfangg@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Fang Duan
investigator title: clinical professor
mesh term: Ophthalmic Solutions
mesh term: Hyaluronic Acid
sharing ipd: Yes