<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/NCT02218827</url>
  </required_header>
  <id_info>
    <org_study_id>dry eye01</org_study_id>
    <nct_id>NCT02218827</nct_id>
  </id_info>
  <brief_title>Topical Steroid Treatment For Dry Eye</brief_title>
  <official_title>Evaluation of Steroidal Treatment For Dry Eye Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many patients refer to an oculoplastic or corneal clinic examination due to dry eye symptoms.&#xD;
      epidemiologic studies estimate that as many as 15% of the population over 60 years suffer&#xD;
      from dry eye. the disease can be treated both topically through several drugs or through&#xD;
      mechanical closure of the lacrimal drainage system. in the past decade a few studies&#xD;
      demonstrated the efficacy of anti inflammatory treatment on dry eye disease due to the&#xD;
      inflammatory process that occurs in it. this treatment rises goblet cell counts but in the&#xD;
      meantime elevates the intra ocular pressure and elevates the risk for infections. steroids&#xD;
      that cause a lower increase in intraocular pressure have not been thoroughly evaluated in dry&#xD;
      eye disease. we with to subjectively and objectively evaluate an FDA approved topical&#xD;
      steroidal drug in the treatment of dry eye.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      30 patients 21 year or older, from both sexes with no previous eyelid or corneal surgeries,&#xD;
      refered to our outpatient clinics will be recruited and evaluated.&#xD;
&#xD;
      the initial examination will include schirmer1 test, Tear break up time test, a full&#xD;
      ophthalmologic evaluation and a dry eye questionaire.&#xD;
&#xD;
      after signing a concent form patient will be treated with Loteprednol Etabonate four times a&#xD;
      ady for a month, then a second examination will take place. after that and according to&#xD;
      necessity patients will be treated with Loteprednol Etabonate two times daily for another&#xD;
      month and return for a follow up examination. intraocular pressure will be evaluated in each&#xD;
      follow up visit as well as dry eye symptoms, schirmer 1 test and tear break up time test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical improvement in dry eye measurements</measure>
    <time_frame>two months</time_frame>
    <description>tear break up time and schirmer 1 test will evaluate improvement in dry eye under medical treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>symptomatic improvement</measure>
    <time_frame>two months</time_frame>
    <description>dry eye questionaire will be evaluated on each follow up</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>dry eye patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Loteprednol Etabonate (FML) topical treatment 1 drop 4 times daily for 1 month then Loteprednol Etabonate (FML) 1 drop 2 times daily for 1 month</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Loteprednol Etabonate (FML)</intervention_name>
    <description>a steroid topical treatment used for moderate dry eye symptoms. this drug causes less increase in intra ocular pressure</description>
    <arm_group_label>dry eye patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  referral for ophthalmic examination due to dry eye symptoms&#xD;
&#xD;
          -  ability to sign a concent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  former corneal, eyelid or lacrimal gland operations&#xD;
&#xD;
          -  former orbital chemotherapy or irradiation treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shay Ofir, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Meir Medical center</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>shay ofir</investigator_full_name>
    <investigator_title>Medical Doctir</investigator_title>
  </responsible_party>
  <keyword>Dry Eye</keyword>
  <keyword>Inflammatory reaction</keyword>
  <keyword>steroids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loteprednol Etabonate</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/NCT02218827
org study id: dry eye01
nct id: NCT02218827
lead sponsor: 
has dmc: Yes
Many patients refer to an oculoplastic or corneal clinic examination due to dry eye symptoms.
      epidemiologic studies estimate that as many as 15% of the population over 60 years suffer
      from dry eye. the disease can be treated both topically through several drugs or through
      mechanical closure of the lacrimal drainage system. in the past decade a few studies
      demonstrated the efficacy of anti inflammatory treatment on dry eye disease due to the
      inflammatory process that occurs in it. this treatment rises goblet cell counts but in the
      meantime elevates the intra ocular pressure and elevates the risk for infections. steroids
      that cause a lower increase in intraocular pressure have not been thoroughly evaluated in dry
      eye disease. we with to subjectively and objectively evaluate an FDA approved topical
      steroidal drug in the treatment of dry eye.
30 patients 21 year or older, from both sexes with no previous eyelid or corneal surgeries,
      refered to our outpatient clinics will be recruited and evaluated.

      the initial examination will include schirmer1 test, Tear break up time test, a full
      ophthalmologic evaluation and a dry eye questionaire.

      after signing a concent form patient will be treated with Loteprednol Etabonate four times a
      ady for a month, then a second examination will take place. after that and according to
      necessity patients will be treated with Loteprednol Etabonate two times daily for another
      month and return for a follow up examination. intraocular pressure will be evaluated in each
      follow up visit as well as dry eye symptoms, schirmer 1 test and tear break up time test.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: clinical improvement in dry eye measurements
time frame: two months
description: tear break up time and schirmer 1 test will evaluate improvement in dry eye under medical treatment
measure: symptomatic improvement
time frame: two months
description: dry eye questionaire will be evaluated on each follow up
arm group label: dry eye patients
arm group type: Experimental
description: Loteprednol Etabonate (FML) topical treatment 1 drop 4 times daily for 1 month then Loteprednol Etabonate (FML) 1 drop 2 times daily for 1 month
intervention type: Drug
intervention name: Loteprednol Etabonate (FML)
description: a steroid topical treatment used for moderate dry eye symptoms. this drug causes less increase in intra ocular pressure
arm group label: dry eye patients
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Shay Ofir, Dr
role: Principal Investigator
affiliation: Meir Medical Center
facility: 
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: shay ofir
investigator title: Medical Doctir
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Loteprednol Etabonate