<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/NCT03265327</url>
  </required_header>
  <id_info>
    <org_study_id>22309</org_study_id>
    <nct_id>NCT03265327</nct_id>
  </id_info>
  <brief_title>Effect of an Oral Supplement Containing Omega-3 and Omega-6 on Dry Eye Symptoms</brief_title>
  <acronym>TURMERIC</acronym>
  <official_title>The Use of a Novel Oral Supplement Containing Omega-3 and Omega-6 Fatty Acids on Dry Eye Symptoms (TURMERIC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nature's Way Canada</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre for Contact Lens Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nature's Way Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the effectiveness of two oral supplements on the ocular signs and&#xD;
      symptoms in symptomatic dry eye patients. Eligible participants will be given one of two oral&#xD;
      supplements to take once a day for up to three months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">June 27, 2018</completion_date>
  <primary_completion_date type="Actual">June 27, 2018</primary_completion_date>
  <phase>N/A</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ocular Surface Disease Index (OSDI) score</measure>
    <time_frame>At screening</time_frame>
    <description>The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Surface Disease Index (OSDI) score</measure>
    <time_frame>At 1 month</time_frame>
    <description>The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Surface Disease Index (OSDI) score</measure>
    <time_frame>At 3 months</time_frame>
    <description>The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Assessment in Dry Eye (SANDE) questionnaire</measure>
    <time_frame>At screening</time_frame>
    <description>The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Assessment in Dry Eye (SANDE) questionnaire</measure>
    <time_frame>At 1 month</time_frame>
    <description>The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Assessment in Dry Eye (SANDE) questionnaire</measure>
    <time_frame>At 3 months</time_frame>
    <description>The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Schirmers test</measure>
    <time_frame>At screening</time_frame>
    <description>The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Schirmers test</measure>
    <time_frame>At 1 month</time_frame>
    <description>The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Schirmers test</measure>
    <time_frame>At 3 months</time_frame>
    <description>The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective non-invasive tear film stability (NIKBUT)</measure>
    <time_frame>At screening</time_frame>
    <description>Time taken for tear film breakup as measured objectively in seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective non-invasive tear film stability (NIKBUT)</measure>
    <time_frame>At 1 month</time_frame>
    <description>Time taken for tear film breakup as measured objectively in seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective non-invasive tear film stability (NIKBUT)</measure>
    <time_frame>At 3 months</time_frame>
    <description>Time taken for tear film breakup as measured objectively in seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-invasive tear break up time (NITBUT)</measure>
    <time_frame>At screening</time_frame>
    <description>Time taken for tear film breakup as measured by a study investigator in seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-invasive tear break up time (NITBUT)</measure>
    <time_frame>At 1 month</time_frame>
    <description>Time taken for tear film breakup as measured by a study investigator in seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-invasive tear break up time (NITBUT)</measure>
    <time_frame>At 3 months</time_frame>
    <description>Time taken for tear film breakup as measured by a study investigator in seconds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Bulbar hyperemia after 3 months</measure>
    <time_frame>At screening, 1 month and 3 months</time_frame>
    <description>The redness of the bulbar conjunctiva of both eyes will be assessed in all four quadrants using the Efron scale (0-4, in 0.1 steps).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Limbal hyperemia after 3 months</measure>
    <time_frame>At screening, 1 month and 3 months</time_frame>
    <description>The redness of the limbal conjunctiva of both eyes will be assessed in all four quadrants using the Efron scale (0-4, in 0.1 steps).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tear meniscus height after 3 months</measure>
    <time_frame>At screening, 1 month and 3 months</time_frame>
    <description>Measurement of tear meniscus height in mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Meiboscore (Arita's scale) after 3 months</measure>
    <time_frame>At screening, 1 month and 3 months</time_frame>
    <description>Graded on 0-3 scale. Grade 0: no dropout, Grade 1: &lt; 1/3 total area dropout, Grade 2: 1/3 to 2/3 total area dropout, Grade 3: &gt; 2/3 total area dropout</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual acuity after 3 months</measure>
    <time_frame>At screening, 1 month and 3 months</time_frame>
    <description>High contrast logMAR VA with computerized charts in high illumination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tear osmolarity after 3 months</measure>
    <time_frame>At screening and 3 months</time_frame>
    <description>Measure of the osmolarity of collected tears.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Omega-3 index after 3 months</measure>
    <time_frame>At screening and 3 months</time_frame>
    <description>Amount of EPA and DHA in erythrocytes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive an oral supplement containing fish oil, evening primrose oil and borage oil.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive an oral supplement containing coconut oil and light olive oil.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oral supplement containing omega-3 and omega-6</intervention_name>
    <description>An oral supplement containing omega-3 and omega-6</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oral supplement containing coconut and olive oil</intervention_name>
    <description>An oral supplement containing coconut oil and olive oil</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Is over 19 years of age and has full legal capacity to volunteer;&#xD;
&#xD;
          2. Has read and signed an information consent letter;&#xD;
&#xD;
          3. Is willing and anticipated to be able to comply with the daily intake of liquid oil&#xD;
             supplements (one teaspoon per day for three months);&#xD;
&#xD;
          4. Is willing and able to follow instructions and maintain the appointment schedule;&#xD;
&#xD;
          5. Exhibit moderate ocular dryness symptoms, defined as:&#xD;
&#xD;
               1. A score of ≥23 on the Ocular Surface Disease Index (OSDI, (Allergan Inc., Irvine,&#xD;
                  CA)) questionnaire;&#xD;
&#xD;
               2. Currently uses, or feels the need to use eye drops to relieve symptoms of&#xD;
                  dryness.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Is participating in any concurrent clinical or research study;&#xD;
&#xD;
          2. Has any known active* ocular disease and/or infection;&#xD;
&#xD;
          3. Currently wears, or has worn contact lenses in the past 3 months;&#xD;
&#xD;
          4. Has sensitivity or an allergy to products that contain fish, soy, coconut oil or olive&#xD;
             oil;&#xD;
&#xD;
          5. Has a systemic condition that in the opinion of the investigator may affect a study&#xD;
             outcome variable;&#xD;
&#xD;
          6. Is using any systemic or topical medications (including topical corticosteroids/NSAIDs&#xD;
             or glaucoma medications) that in the opinion of the investigator may affect a study&#xD;
             outcome variable;&#xD;
&#xD;
          7. Is currently taking, or has used, any omega-3 or omega-6 supplements in the last three&#xD;
             months;&#xD;
&#xD;
          8. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;&#xD;
&#xD;
          9. Is pregnant, lactating or planning a pregnancy at the time of enrolment;&#xD;
&#xD;
         10. Is aphakic;&#xD;
&#xD;
         11. Has undergone refractive error surgery;&#xD;
&#xD;
         12. Is an employee of the Centre for Contact Lens Research;&#xD;
&#xD;
         13. Has taken part in another (pharmaceutical) research study within the last 30 days;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre for Contact Lens Research</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03265327
org study id: 22309
nct id: NCT03265327
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will investigate the effectiveness of two oral supplements on the ocular signs and
      symptoms in symptomatic dry eye patients. Eligible participants will be given one of two oral
      supplements to take once a day for up to three months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Ocular Surface Disease Index (OSDI) score
time frame: At screening
description: The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.
measure: Ocular Surface Disease Index (OSDI) score
time frame: At 1 month
description: The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.
measure: Ocular Surface Disease Index (OSDI) score
time frame: At 3 months
description: The OSDI is assessed on a scale of 0 and 100. A higher composite score indicates more severe dryness.
measure: Symptom Assessment in Dry Eye (SANDE) questionnaire
time frame: At screening
description: The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale.
measure: Symptom Assessment in Dry Eye (SANDE) questionnaire
time frame: At 1 month
description: The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale.
measure: Symptom Assessment in Dry Eye (SANDE) questionnaire
time frame: At 3 months
description: The Symptom Assessment in Dry Eye (SANDE) questionnaire is a dry eye questionnaire that asks participants to describe the frequency and severity of their dry eye symptoms using a visual analogue scale.
measure: Schirmers test
time frame: At screening
description: The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm.
measure: Schirmers test
time frame: At 1 month
description: The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm.
measure: Schirmers test
time frame: At 3 months
description: The small strip of paper is removed from the Schirmer test package, folded at one end, and is inserted into the outer corner of the participant's eyes. The participant is asked to close their eyes and wait for 5 minutes. After 5 minutes, the paper is removed and the length of which the paper strip is wetted is recorded in mm.
measure: Objective non-invasive tear film stability (NIKBUT)
time frame: At screening
description: Time taken for tear film breakup as measured objectively in seconds.
measure: Objective non-invasive tear film stability (NIKBUT)
time frame: At 1 month
description: Time taken for tear film breakup as measured objectively in seconds.
measure: Objective non-invasive tear film stability (NIKBUT)
time frame: At 3 months
description: Time taken for tear film breakup as measured objectively in seconds.
measure: Non-invasive tear break up time (NITBUT)
time frame: At screening
description: Time taken for tear film breakup as measured by a study investigator in seconds.
measure: Non-invasive tear break up time (NITBUT)
time frame: At 1 month
description: Time taken for tear film breakup as measured by a study investigator in seconds.
measure: Non-invasive tear break up time (NITBUT)
time frame: At 3 months
description: Time taken for tear film breakup as measured by a study investigator in seconds.
measure: Change in Bulbar hyperemia after 3 months
time frame: At screening, 1 month and 3 months
description: The redness of the bulbar conjunctiva of both eyes will be assessed in all four quadrants using the Efron scale (0-4, in 0.1 steps).
measure: Change in Limbal hyperemia after 3 months
time frame: At screening, 1 month and 3 months
description: The redness of the limbal conjunctiva of both eyes will be assessed in all four quadrants using the Efron scale (0-4, in 0.1 steps).
measure: Change in Tear meniscus height after 3 months
time frame: At screening, 1 month and 3 months
description: Measurement of tear meniscus height in mm.
measure: Change in Meiboscore (Arita's scale) after 3 months
time frame: At screening, 1 month and 3 months
description: Graded on 0-3 scale. Grade 0: no dropout, Grade 1: < 1/3 total area dropout, Grade 2: 1/3 to 2/3 total area dropout, Grade 3: > 2/3 total area dropout
measure: Change in Visual acuity after 3 months
time frame: At screening, 1 month and 3 months
description: High contrast logMAR VA with computerized charts in high illumination
measure: Change in Tear osmolarity after 3 months
time frame: At screening and 3 months
description: Measure of the osmolarity of collected tears.
measure: Change in Omega-3 index after 3 months
time frame: At screening and 3 months
description: Amount of EPA and DHA in erythrocytes
arm group label: Treatment
arm group type: Experimental
description: Subjects will receive an oral supplement containing fish oil, evening primrose oil and borage oil.
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive an oral supplement containing coconut oil and light olive oil.
intervention type: Dietary Supplement
intervention name: Oral supplement containing omega-3 and omega-6
description: An oral supplement containing omega-3 and omega-6
arm group label: Treatment
intervention type: Dietary Supplement
intervention name: Oral supplement containing coconut and olive oil
description: An oral supplement containing coconut oil and olive oil
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
sharing ipd: No