<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/NCT01679015</url>
  </required_header>
  <id_info>
    <org_study_id>AL-001</org_study_id>
    <nct_id>NCT01679015</nct_id>
  </id_info>
  <brief_title>Evaluating Patients With Eye Allergies and Determining if There Are Also Dry Eyes</brief_title>
  <official_title>Concomitant Dry Eye in Patients With Ocular Allergy: an Under Recognized and Poorly Managed Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schwartz Laser Eye Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Schwartz Laser Eye Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluating the percentage of patients that suffer from eye allergies and determining whether&#xD;
      they also have dry eyes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of dry eye in an allergic population presenting to a high volume optometry practice</measure>
    <time_frame>up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of allergic patients with moderate to severe ocular signs and symptoms</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">250</enrollment>
  <condition>Dry Eyes</condition>
  <condition>Allergic Conjunctivitis</condition>
  <arm_group>
    <arm_group_label>Dry Eyes, Eye Allergies</arm_group_label>
    <description>Patients with ocular allergies and those with dry eyes.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be screened from existing patient database.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Males and females at least 18 years of age&#xD;
&#xD;
          -  Personal history of allergic disorders including but not limited to allergic&#xD;
             conjunctivitis, allergic rhinitis, contact dermatitis and other eczema, and asthma&#xD;
&#xD;
          -  Diagnosis of allergic conjunctivitis&#xD;
&#xD;
          -  Presence of any of the following signs including conjunctival redness and papillae,&#xD;
             chemosis, red edematous eyelids, reduced tear clearance, reduced TBUT, vital staining,&#xD;
             stringy discharge, and/or symptoms including ocular itching, burning and tearing,&#xD;
             runny nose or itchy throat&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active ocular or systemic infection&#xD;
&#xD;
          -  History of ocular infection within past 6 months&#xD;
&#xD;
          -  Presence of punctal plugs&#xD;
&#xD;
          -  Recent ocular surgery within past 6 months&#xD;
&#xD;
          -  Current use of chemotherapeutic agents&#xD;
&#xD;
          -  Presence of ocular trauma&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Women who are pregnant, nursing or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc R Bloomenstein, O.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schwartz Laser Eye Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schwartz Laser Eye Center</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>June 2, 2016</last_update_submitted>
  <last_update_submitted_qc>June 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schwartz Laser Eye Center</investigator_affiliation>
    <investigator_full_name>Marc R.Bloomenstein</investigator_full_name>
    <investigator_title>O.D.</investigator_title>
  </responsible_party>
  <keyword>Burning</keyword>
  <keyword>Dryness</keyword>
  <keyword>Itching</keyword>
  <keyword>Blurry Vision</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>
    <mesh_term>Conjunctivitis</mesh_term>
    <mesh_term>Conjunctivitis, Allergic</mesh_term>
  </condition_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/NCT01679015
org study id: AL-001
nct id: NCT01679015
lead sponsor: 
collaborator: 
has dmc: No
Evaluating the percentage of patients that suffer from eye allergies and determining whether
      they also have dry eyes.
observational model: Case-Only
time perspective: Prospective
measure: Prevalence of dry eye in an allergic population presenting to a high volume optometry practice
time frame: up to 2 years
measure: Prevalence of allergic patients with moderate to severe ocular signs and symptoms
time frame: up to 2 years
arm group label: Dry Eyes, Eye Allergies
description: Patients with ocular allergies and those with dry eyes.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc R Bloomenstein, O.D.
role: Principal Investigator
affiliation: Schwartz Laser Eye Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Schwartz Laser Eye Center
investigator full name: Marc R.Bloomenstein
investigator title: O.D.
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Conjunctivitis
mesh term: Conjunctivitis, Allergic