<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/NCT02260973</url>
  </required_header>
  <id_info>
    <org_study_id>PRN 20145</org_study_id>
    <nct_id>NCT02260973</nct_id>
  </id_info>
  <brief_title>The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity</brief_title>
  <official_title>The Influence of PRN Omega-3 Nutritional Supplement on Visual Acuity Outcomes In Cases Undergoing Cataract Surgery: A Pilot Study.</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>
      This is a randomized, masked, placebo controlled study to assess the effect on visual acuity,&#xD;
      if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cataract, Dry Eye Disease</condition>
  <arm_group>
    <arm_group_label>Omega-3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>re esterified TG omega-3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Safflower Oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>vegetable 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>Safflower Oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of nuclear or cortical lens opacities in one/both eyes&#xD;
&#xD;
          -  Physician diagnosis of age related cataract&#xD;
&#xD;
          -  Good overall physical constitution&#xD;
&#xD;
          -  All participants must be follow the same regimen for surgery related medications, both&#xD;
             pre and post surgery. (Antibiotic, NSAID and Steroid eye drops)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects requiring Premium IOLs/multifocal implants&#xD;
&#xD;
          -  Advanced cataract&#xD;
&#xD;
          -  Severe Age-Related Macular Degeneration Presence or history of Glaucoma&#xD;
&#xD;
          -  Presence or history of Diabetes Mellitus&#xD;
&#xD;
          -  Any Retinal pathology - retinal detachment, retinitis pigmentosa, diabetic&#xD;
             retinopathy, etc&#xD;
&#xD;
          -  Vision loss due to Central retinal artery occlusion or Central retinal vein occlusion&#xD;
&#xD;
          -  Vision loss due to presence of large pituitary tumors or aneurysms&#xD;
&#xD;
          -  Vision loss due to optic tract lesions&#xD;
&#xD;
          -  Vision loss due to bleeding into aqueous or vitreous chamber&#xD;
&#xD;
          -  Vision loss due to drug toxicity: Amiodarone, anti-tuberculosis drugs,&#xD;
             hydroxychloroquine, tamoxifen&#xD;
&#xD;
          -  Major cardiovascular or cerebral events in the past 12 months&#xD;
&#xD;
          -  Allergy to fish oil or safflower oil&#xD;
&#xD;
          -  Pregnancy or lactation at any time during the study&#xD;
&#xD;
          -  Newly started or increased the dose of chronic systemic medication known to affect&#xD;
             tear production including, but not limited to antihistamines, antidepressants,&#xD;
             diuretics, corticosteroids or immunomodulators within 30 days of Screening or at any&#xD;
             time during the study&#xD;
&#xD;
          -  Participation in any other study involving an investigational drug or device within&#xD;
             the past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bradley Williams, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southern Eye Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Eye Institute</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Crabtree</last_name>
      <phone>859-331-9000</phone>
      <phone_ext>4120</phone_ext>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southern Eye Associates</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kim Williams</last_name>
      <email>kim.williams@innovativeclinicalresearch.net</email>
    </contact>
  </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>Cataract</mesh_term>
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</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/NCT02260973
org study id: PRN 20145
nct id: NCT02260973
lead sponsor: 
This is a randomized, masked, placebo controlled study to assess the effect on visual acuity,
      if any, of the PRN omega-3 nutritional supplement in subjects undergoing cataract surgery.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Visual Acuity
time frame: 8 weeks
arm group label: Omega-3
arm group type: Active Comparator
description: re esterified TG omega-3
arm group label: Safflower Oil
arm group type: Placebo Comparator
description: vegetable oil
intervention type: Dietary Supplement
intervention name: Omega-3 (Triglyceride form)
arm group label: Omega-3
arm group label: Safflower Oil
criteria: 
gender: All
minimum age: 30 Years
maximum age: 90 Years
healthy volunteers: No
last name: Bradley Williams, MD
role: Principal Investigator
affiliation: Southern Eye Associates
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Cataract
mesh term: Dry Eye Syndromes
mesh term: Eye Diseases
mesh term: Keratoconjunctivitis Sicca