<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/NCT03013959</url>
  </required_header>
  <id_info>
    <org_study_id>PekingUMC</org_study_id>
    <nct_id>NCT03013959</nct_id>
  </id_info>
  <brief_title>Observation on the Herpes Simplex Keratitis</brief_title>
  <acronym>OHSV</acronym>
  <official_title>Observation on Effect of Anti--inflammatory and Inhibition of Recurrence on the Herpes Simplex Keratitis After Topical NSAIDs Administration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As is reported, NSAIDs(pranoprofen ,bromfenac) eye drops can suppress herpes simplex&#xD;
      virus（HSV-1） reactivation and reduce inflammatory reaction in vitro and in vivo. In Clinical,&#xD;
      there is no risk of corneal tissue melting, glaucoma, cataract by topical application of&#xD;
      NSAIDs. To explore more effective clinical treatment of viral keratitis patients to control&#xD;
      the inflammatory damage, save the visual function and reduce the recurrence of the virus ,we&#xD;
      observe the effect of anti-inflammatory and inhibition of recurrence on the herpes simplex&#xD;
      virus after topical NSAIDs administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Viral keratitis has now become the highest incidence and the most severe-caused blindness&#xD;
      corneal disease in the worldwide, as is superior to bacterial keratitis and fungal keratitis.&#xD;
      At present, clinical treatments mainly depend on local and systematic use of antiviral drugs&#xD;
      for viral keratitis, which can inhibit replication of viruses in corneal tissues and directly&#xD;
      damage viral action. However, basal studies for viral keratitis have suggested that&#xD;
      pathological immune injury produced by the body also play an important role in the formation&#xD;
      of corneal ulcer, the damage of visual function in patients, during the necrotic stromal&#xD;
      inflammation phase, endotheliitis phase and even serious combination of iridocyclitis phase&#xD;
      of viral keratitis. There is, however, a larger controversy in the hormone therapy for this&#xD;
      disease clearly caused by pathological immune injury in medical world. Patients with&#xD;
      infectious keratitis caused by viral infection, who receive hormone treatment, may cause&#xD;
      viral replication enhanced and out of control, and hormone itself could also cause&#xD;
      spontaneous corneal tissues fusion; hence, treatments combined with hormone have a certain&#xD;
      risks. In clinical treatments, permanent corneal opacity caused by corneal inflammation&#xD;
      responses will cause patients permanent visual acuity loss, after patients' corneal lesions&#xD;
      were controlled with simple use of antiviral drugs. Another important reason is the high&#xD;
      incidence of blindness caused by viral keratitis: herpesvirus, such as herpes simplex virus&#xD;
      and herpes zoster virus, will involve trigeminal ganglia and hide after primary infection,&#xD;
      and will repeatedly recur under the stimulation of excessive drinking, menstruation, taking a&#xD;
      cold and operation etc.. Viral keratitis often does not cause patients severe visual&#xD;
      impairment at initial onset. But, viruses in patients with herpes simplex virus keratitis&#xD;
      show extremely high recurrence rates. As suggested in epidemiologic studies in the&#xD;
      Euro-American countries, its recurrence rate could be up to 30% in the first year, and 46% in&#xD;
      the second years. In most cases, transparent corneal tissues develop nephelium and even&#xD;
      macular nebula opacities after repeated recurring, and patients eventually lose visual&#xD;
      acuity, becoming people with blindness and disabilities. Nonsteroidal antiinflammatory drugs,&#xD;
      such as pranoprofen and bromfenac sodium, show significant inhibition of virus recurrence and&#xD;
      relief of corneal inflammation responses in experiments in vitro and animal experiments,&#xD;
      which indicated in previous studies. In clinical, local application of nonsteroidal&#xD;
      antiinflammatory drugs does not result in spontaneous corneal tissue fusion, drug-induced&#xD;
      glaucoma, drug-induced cataract and other risks. In order to seek more effective clinical&#xD;
      treatments for viral keratitis patients in terms of controlling inflammation injury,&#xD;
      preserving visual functions and reducing virus recurrence, this study observed that&#xD;
      pranoprofen, a nonsteroidal antiinflammatory drug, inhibits pathological immune injury of&#xD;
      viral keratitis and prevents this disease recurring, according to the basal research&#xD;
      background of viral keratitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>inhibition of recurrence on the herpes simplex virus</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Keratitis, Herpetic</condition>
  <arm_group>
    <arm_group_label>Resting control group</arm_group_label>
    <description>The rest group is to study the effect of the inhibition of recurrence . Patients with redness, pain, decreased visual acuity and other reaction activity in the past 30 days are observed as control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resting test group</arm_group_label>
    <description>The rest group is to study the effect of the inhibition of recurrence . Patients with redness, pain, decreased visual acuity and other reaction activity in the past 30 days are treated with pranoprofen and observed as test group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active control group</arm_group_label>
    <description>The active control group is to study the effect of anti--inflammatory. Patients with a new redness, pain, decreased visual acuity and other reaction activity recently are observed as control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active test group</arm_group_label>
    <description>The active test group is to study the effect of anti--inflammatory. Patients with a new redness, pain, decreased visual acuity and other reaction activity recently are treated with pranoprofen and observed as test group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pranoprofen</intervention_name>
    <description>it is an NSAIDs.As is reported, NSAIDs(pranoprofen) eye drops can suppress herpes simplex virus（HSV-1） reactivation and reduce inflammatory reaction in vitro and in vivo. In Clinical, there is no risk of corneal tissue melting, glaucoma, cataract by topical application of NSAIDs.</description>
    <arm_group_label>Active test group</arm_group_label>
    <arm_group_label>Resting test group</arm_group_label>
    <other_name>Pranopulin</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1. Eyes with typical stromal infiltration, typical herpes simplex virus keratitis&#xD;
             patients&#xD;
&#xD;
          2. Eyes with a history of recurrent erythema, pain, recurrent disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Eyes with typical stromal infiltration, typical herpes simplex virus keratitis&#xD;
             patients&#xD;
&#xD;
          2. Eyes with a history of recurrent erythema, pain, recurrent disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with immune dysfunction or receiving immunosuppressive therapy&#xD;
&#xD;
          2. Patients with cardiac and pulmonary insufficiency&#xD;
&#xD;
          3. Patients with liver function, renal insufficiency&#xD;
&#xD;
          4. Patients with allergic reactions to related drugs&#xD;
&#xD;
          5. Patients with history of corneal surgery&#xD;
&#xD;
          6. Pregnant women and breast-feeding women&#xD;
&#xD;
          7. Patients with diabetes&#xD;
&#xD;
          8. Patients with malignant tumor history&#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_official>
    <last_name>Ying Li, md</last_name>
    <role>Study Director</role>
    <affiliation>Peking Union Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yang Jiang, md</last_name>
    <phone>+8613521676533</phone>
    <email>jiangyangpumch@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang Jiang, md</last_name>
      <phone>+8613521676533</phone>
      <email>jiangyangpumch@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College</investigator_affiliation>
    <investigator_full_name>Yang Jiang</investigator_full_name>
    <investigator_title>Attending Doctor，md</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Herpes Simplex</mesh_term>
    <mesh_term>Keratitis, Herpetic</mesh_term>
    <mesh_term>Keratitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pyranoprofen</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/NCT03013959
org study id: PekingUMC
nct id: NCT03013959
lead sponsor: 
has dmc: Yes
As is reported, NSAIDs(pranoprofen ,bromfenac) eye drops can suppress herpes simplex
      virus（HSV-1） reactivation and reduce inflammatory reaction in vitro and in vivo. In Clinical,
      there is no risk of corneal tissue melting, glaucoma, cataract by topical application of
      NSAIDs. To explore more effective clinical treatment of viral keratitis patients to control
      the inflammatory damage, save the visual function and reduce the recurrence of the virus ,we
      observe the effect of anti-inflammatory and inhibition of recurrence on the herpes simplex
      virus after topical NSAIDs administration.
Viral keratitis has now become the highest incidence and the most severe-caused blindness
      corneal disease in the worldwide, as is superior to bacterial keratitis and fungal keratitis.
      At present, clinical treatments mainly depend on local and systematic use of antiviral drugs
      for viral keratitis, which can inhibit replication of viruses in corneal tissues and directly
      damage viral action. However, basal studies for viral keratitis have suggested that
      pathological immune injury produced by the body also play an important role in the formation
      of corneal ulcer, the damage of visual function in patients, during the necrotic stromal
      inflammation phase, endotheliitis phase and even serious combination of iridocyclitis phase
      of viral keratitis. There is, however, a larger controversy in the hormone therapy for this
      disease clearly caused by pathological immune injury in medical world. Patients with
      infectious keratitis caused by viral infection, who receive hormone treatment, may cause
      viral replication enhanced and out of control, and hormone itself could also cause
      spontaneous corneal tissues fusion; hence, treatments combined with hormone have a certain
      risks. In clinical treatments, permanent corneal opacity caused by corneal inflammation
      responses will cause patients permanent visual acuity loss, after patients' corneal lesions
      were controlled with simple use of antiviral drugs. Another important reason is the high
      incidence of blindness caused by viral keratitis: herpesvirus, such as herpes simplex virus
      and herpes zoster virus, will involve trigeminal ganglia and hide after primary infection,
      and will repeatedly recur under the stimulation of excessive drinking, menstruation, taking a
      cold and operation etc.. Viral keratitis often does not cause patients severe visual
      impairment at initial onset. But, viruses in patients with herpes simplex virus keratitis
      show extremely high recurrence rates. As suggested in epidemiologic studies in the
      Euro-American countries, its recurrence rate could be up to 30% in the first year, and 46% in
      the second years. In most cases, transparent corneal tissues develop nephelium and even
      macular nebula opacities after repeated recurring, and patients eventually lose visual
      acuity, becoming people with blindness and disabilities. Nonsteroidal antiinflammatory drugs,
      such as pranoprofen and bromfenac sodium, show significant inhibition of virus recurrence and
      relief of corneal inflammation responses in experiments in vitro and animal experiments,
      which indicated in previous studies. In clinical, local application of nonsteroidal
      antiinflammatory drugs does not result in spontaneous corneal tissue fusion, drug-induced
      glaucoma, drug-induced cataract and other risks. In order to seek more effective clinical
      treatments for viral keratitis patients in terms of controlling inflammation injury,
      preserving visual functions and reducing virus recurrence, this study observed that
      pranoprofen, a nonsteroidal antiinflammatory drug, inhibits pathological immune injury of
      viral keratitis and prevents this disease recurring, according to the basal research
      background of viral keratitis.
observational model: Case-Control
measure: inhibition of recurrence on the herpes simplex virus
time frame: 12 months
arm group label: Resting control group
description: The rest group is to study the effect of the inhibition of recurrence . Patients with redness, pain, decreased visual acuity and other reaction activity in the past 30 days are observed as control group
arm group label: Resting test group
description: The rest group is to study the effect of the inhibition of recurrence . Patients with redness, pain, decreased visual acuity and other reaction activity in the past 30 days are treated with pranoprofen and observed as test group
arm group label: Active control group
description: The active control group is to study the effect of anti--inflammatory. Patients with a new redness, pain, decreased visual acuity and other reaction activity recently are observed as control group
arm group label: Active test group
description: The active test group is to study the effect of anti--inflammatory. Patients with a new redness, pain, decreased visual acuity and other reaction activity recently are treated with pranoprofen and observed as test group
intervention type: Drug
intervention name: Pranoprofen
description: it is an NSAIDs.As is reported, NSAIDs(pranoprofen) eye drops can suppress herpes simplex virus（HSV-1） reactivation and reduce inflammatory reaction in vitro and in vivo. In Clinical, there is no risk of corneal tissue melting, glaucoma, cataract by topical application of NSAIDs.
arm group label: Active test group
arm group label: Resting test group
other name: Pranopulin
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ying Li, md
role: Study Director
affiliation: Peking Union Medical College
last name: Yang Jiang, md
phone: +8613521676533
email: jiangyangpumch@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College
investigator full name: Yang Jiang
investigator title: Attending Doctor，md
mesh term: Herpes Simplex
mesh term: Keratitis, Herpetic
mesh term: Keratitis
mesh term: Pyranoprofen
sharing ipd: Yes