<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/NCT02260960</url>
  </required_header>
  <id_info>
    <org_study_id>PRN 20142</org_study_id>
    <nct_id>NCT02260960</nct_id>
  </id_info>
  <brief_title>The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease</brief_title>
  <official_title>The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Physician Recommended Nutriceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Physician Recommended Nutriceuticals</source>
  <brief_summary>
    <textblock>
      The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye&#xD;
      related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity,&#xD;
      Schirmer-1 test values, corneal staining, and fluorescein tear break-up time) when compared&#xD;
      to administration of placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 2/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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tear Osmolarity</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Dry Eye Disease</condition>
  <arm_group>
    <arm_group_label>Omega-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reesterified Triglyceride form omega 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>safflower oil</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3 (Triglyceride form)</intervention_name>
    <arm_group_label>Omega-3</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 and ≤ 90 at the time of informed consent&#xD;
&#xD;
          -  Subjects experiencing dry eye based on a global clinical assessment by the attending&#xD;
             clinician, subject complaint of dry eye symptoms&#xD;
&#xD;
          -  Presence or History of Tear Osmolarity (Appendix 2) equal to or greater than 312&#xD;
             mOsm/L in at least one eye&#xD;
&#xD;
          -  Presence or History of Meibomian Gland Dysfunction (Grade 1 or 2) in at least one eye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to fish oil or safflower oil&#xD;
&#xD;
          -  Clinically significant eyelid deformity or eyelid movement disorder that is caused by&#xD;
             conditions such as notch deformity, incomplete lid closure, entropion, ectropion,&#xD;
             hordeola or chalazia&#xD;
&#xD;
          -  Previous ocular disease leaving sequelae or requiring current topical eye therapy&#xD;
             other than for DED, including, but not limited to: active corneal or conjunctival&#xD;
             infection of the eye and ocular surface scarring Active ocular or nasal allergy&#xD;
&#xD;
          -  LASIK or PRK surgery that was performed within one year of the Screening Visit or at&#xD;
             any time during the study&#xD;
&#xD;
          -  Ophthalmologic drop use within 2 hours of any study visits. Any OTC habitual&#xD;
             artificial tear should be continued at the same frequency and no change in drop brand&#xD;
&#xD;
          -  Contact lens wear within 12 hours of any study visits&#xD;
&#xD;
          -  Pregnancy or lactation during the study&#xD;
&#xD;
          -  Abnormal nasolacrimal drainage (by history)&#xD;
&#xD;
          -  Punctal cauterization or punctal plug placement within 60 days of screening&#xD;
&#xD;
          -  Prohibited Medications - Cyclosporine (Restasis®); any topical prescription&#xD;
             medications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or&#xD;
             topical macrolides; oral nutraceuticals (flax, black currant seed oils, etc…) within 3&#xD;
             weeks (21 days) of Screening and at any time during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alice Epitropoulos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Eye Center of Columbus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Eye Center of Columbus</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>August 2, 2016</last_update_submitted>
  <last_update_submitted_qc>August 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Eye Diseases</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/NCT02260960
org study id: PRN 20142
nct id: NCT02260960
lead sponsor: 
The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye
      related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity,
      Schirmer-1 test values, corneal staining, and fluorescein tear break-up time) when compared
      to administration of placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Tear Osmolarity
time frame: 12 weeks
arm group label: Omega-3
arm group type: Experimental
description: Reesterified Triglyceride form omega 3
arm group label: Placebo
arm group type: Placebo Comparator
description: safflower oil
intervention type: Dietary Supplement
intervention name: Omega-3 (Triglyceride form)
arm group label: Omega-3
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Alice Epitropoulos, MD
role: Principal Investigator
affiliation: The Eye Center of Columbus
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases