<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/NCT01724892</url>
  </required_header>
  <id_info>
    <org_study_id>othana001</org_study_id>
    <nct_id>NCT01724892</nct_id>
  </id_info>
  <brief_title>Comparison the Effects of Dexamethasone and Loteprednol on Epithelial Healing</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khon Kaen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Khon Kaen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Corticosteroid has been used for the treatment after phototherapeutic keratectomy (PRK).&#xD;
      Dexamethasone, a potent steroid can retard the corneal epithelial healing rate and has&#xD;
      numerous serious complications, especially glaucoma. Loteprednol, a new generation of&#xD;
      corticosteroid has less potency than dexamethasone and was proposed to has less side effect&#xD;
      regarding intraocular pressure (IOP) elevation. Therefore, Investigators would like to&#xD;
      compare the effect of dexamethasone and loteprednol on corneal epithelial healing rate after&#xD;
      PRK and risk of glaucoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>corneal epithelial healing</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>intraocular pressure</measure>
    <time_frame>6 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Epithelial Defect After Phototherapeutic Keratectomy</condition>
  <arm_group>
    <arm_group_label>Loteprednol etabonate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical Loteprednol etabonate eye drop 0.5%, 4 times a day, 3 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical Dexamethasone eye drop 0.1%, 4 times a day, 3 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <arm_group_label>Loteprednol etabonate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Loteprednol etabonate</intervention_name>
    <arm_group_label>Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the patient with epithelial defect after phototherapeutic keratectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the patient with systemic disease such as diabetes and connective tissue disease&#xD;
&#xD;
          -  the patient with ocular surface disease such as dry eye and recurrent corneal erosion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Onsiri Thanathanee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Khon Kaen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Onsiri Thanathanee</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Srinagarind Hospital</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed?term=dexamethasone%20AND%20loteprednol</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Amon M, Busin M. Loteprednol etabonate ophthalmic suspension 0.5 %: efficacy and safety for postoperative anti-inflammatory use. Int Ophthalmol. 2012 Oct;32(5):507-17. doi: 10.1007/s10792-012-9589-2. Epub 2012 Jun 16.</citation>
    <PMID>22707339</PMID>
  </reference>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>March 14, 2014</last_update_submitted>
  <last_update_submitted_qc>March 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Khon Kaen University</investigator_affiliation>
    <investigator_full_name>Onsiri Thanathanee</investigator_full_name>
    <investigator_title>othana</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loteprednol Etabonate</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01724892
org study id: othana001
nct id: NCT01724892
lead sponsor: 
has dmc: Yes
Corticosteroid has been used for the treatment after phototherapeutic keratectomy (PRK).
      Dexamethasone, a potent steroid can retard the corneal epithelial healing rate and has
      numerous serious complications, especially glaucoma. Loteprednol, a new generation of
      corticosteroid has less potency than dexamethasone and was proposed to has less side effect
      regarding intraocular pressure (IOP) elevation. Therefore, Investigators would like to
      compare the effect of dexamethasone and loteprednol on corneal epithelial healing rate after
      PRK and risk of glaucoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: corneal epithelial healing
time frame: 1 month
measure: intraocular pressure
time frame: 6 month
arm group label: Loteprednol etabonate
arm group type: Active Comparator
description: Topical Loteprednol etabonate eye drop 0.5%, 4 times a day, 3 weeks
arm group label: Dexamethasone
arm group type: Active Comparator
description: Topical Dexamethasone eye drop 0.1%, 4 times a day, 3 weeks
intervention type: Drug
intervention name: Dexamethasone
arm group label: Loteprednol etabonate
intervention type: Drug
intervention name: Loteprednol etabonate
arm group label: Dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Onsiri Thanathanee, MD
role: Principal Investigator
affiliation: Khon Kaen University
facility: 
facility: 
country: Thailand
url: http://www.ncbi.nlm.nih.gov/pubmed?term=dexamethasone%20AND%20loteprednol
description: Related Info
citation: Amon M, Busin M. Loteprednol etabonate ophthalmic suspension 0.5 %: efficacy and safety for postoperative anti-inflammatory use. Int Ophthalmol. 2012 Oct;32(5):507-17. doi: 10.1007/s10792-012-9589-2. Epub 2012 Jun 16.
PMID: 22707339
responsible party type: Principal Investigator
investigator affiliation: Khon Kaen University
investigator full name: Onsiri Thanathanee
investigator title: othana
mesh term: Loteprednol Etabonate
mesh term: Dexamethasone