<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/NCT02980224</url>
  </required_header>
  <id_info>
    <org_study_id>OmegaD-2016-001</org_study_id>
    <nct_id>NCT02980224</nct_id>
  </id_info>
  <brief_title>Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease</brief_title>
  <official_title>A Randomized, Multicenter, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OmegaD LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OmegaD LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 3 study to evaluate the safety and efficacy of OmegaD softgels for the&#xD;
      treatment of dry eye disease. A daily dose of 2 OmegaD softgels dosed orally BID will be&#xD;
      compared to 2 placebo softgels dosed orally BID for 84 days. Approximately 164 subjects will&#xD;
      be evaluated for their signs and symptoms of dry eye disease and for safety throughout the&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inflammation is a key component of dry eye disease. Increasing the systemic levels of omega-3&#xD;
      fatty acids relative to omega-6 levels can mediate immune responses. Evaluating whether&#xD;
      omega-3 supplementation can improve dry eye disease signs, symptoms and associated measures&#xD;
      of inflammation may present a new therapeutic option for dry eye disease.&#xD;
&#xD;
      The primary objective of this study is to evaluate the safety and efficacy of twice daily&#xD;
      (BID) dosing of OmegaD softgels in subjects with dry eye disease.&#xD;
&#xD;
      Male and female subjects between 18 years and 90 years of age, with patient-reported dry eye&#xD;
      symptoms and a clinical diagnosis of dry eye disease supported by global clinical assessment&#xD;
      will be screened and enrolled. Each subject must have, in at least one eye, tear osmolarity&#xD;
      of ≥ 312 mOsm/L and meibomian gland dysfunction as defined by a grade of 1 or 2 on the&#xD;
      meibomian orifice size scale at both Screening and Baseline in at least one eye. In addition,&#xD;
      Tear break up time (TBUT) must be ≤ 7 seconds in both eyes at both Screening and Baseline and&#xD;
      the Schirmer's test score in both eye(s) must be ≥ 5 mm at Baseline.&#xD;
&#xD;
      Approximately 164 subjects will be randomized (1:1) to 1 of 2 treatment arms and treated for&#xD;
      84 days (12 weeks) with either OmegaD softgels; 2 softgels BID or placebo softgels; 2&#xD;
      softgels BID. The study will be double-masked with OmegaD and placebo being&#xD;
      identical-appearing softgels.&#xD;
&#xD;
      Subjects will participate in safety and efficacy assessments throughout the study. Efficacy&#xD;
      assessments will include, tear osmolarity, meibomian gland dysfunction grading, TBUT,&#xD;
      Schirmer's Test, and dry eye symptoms based on the OSDI questionnaire, Safety assessments&#xD;
      will include, slit lamp examination and adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Tear Break up Time(TBUT ) at Day 84</measure>
    <time_frame>Baseline and 84 Days</time_frame>
    <description>The difference between Baseline (Day 1) and Day 84 in Tear Break Up Time. TBUT is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as observed via slit lamp examination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Dry Eye Symptom Scores (OSDI Questionnaire)</measure>
    <time_frame>Baseline and 84 Days</time_frame>
    <description>Difference from Baseline (Day 1) to Day 84 in the OSDI Questionnaire (dry eye symptom score). Responses evaluate a subjects experience of a symptom on the following scale:&#xD;
0 (none of the time)&#xD;
(some of the time)&#xD;
(half of the time)&#xD;
(most of the time)&#xD;
(all of the time)&#xD;
The 12 questions are as follows:&#xD;
Have you experienced any of the following during the last week:&#xD;
Eyes that are sensitive to light&#xD;
Eyes that feel gritty&#xD;
Painful or sore eyes&#xD;
Blurred vision&#xD;
Poor vision&#xD;
Have problems with your eyes limited you in performance of any of the following during the last week:&#xD;
Reading&#xD;
Driving at night&#xD;
Working with a computer or bank machine (ATM)&#xD;
Watching TV&#xD;
Have your eyes felt uncomfortable in any of the following situations during the last week:&#xD;
Windy conditions&#xD;
Places or areas with low humidity (very dry)&#xD;
Areas that are air conditioned&#xD;
A higher score means a worse outcome. The scores for the 12 questions are added together.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Frequency and Severity of Adverse Events</measure>
    <time_frame>84 Days</time_frame>
    <description>Number and Percentage of Subjects Reporting Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>OmegaD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OmegaD Softgels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Softgels</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OmegaD</intervention_name>
    <description>OmegaD Softgels</description>
    <arm_group_label>OmegaD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo Softgels</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects age ≥ 18 years and ≤ 90 years on the date of informed consent.&#xD;
&#xD;
          2. All subjects must provide signed written consent prior to participation in any study&#xD;
             related procedures.&#xD;
&#xD;
          3. Patient-reported dry eye symptoms.&#xD;
&#xD;
          4. Clinical diagnosis of dry eye disease supported by global clinical assessment.&#xD;
&#xD;
          5. Presence of tear osmolarity in at least one eye ≥ 312 mOsm/L at both Screening and&#xD;
             Baseline.&#xD;
&#xD;
          6. Presence of meibomian gland dysfunction as defined by a grade of 1 or 2 on the&#xD;
             meibomian orifice size scale in at least one eye at both Screening and Baseline. The&#xD;
             qualifying osmolarity level and meibomian orifice size grade must be present in the&#xD;
             same eye at both Screening and Baseline if only one eye qualifies.&#xD;
&#xD;
          7. Female subjects of childbearing potential must have a negative urine pregnancy test at&#xD;
             Screening. Women of childbearing potential (i.e., women who are not either&#xD;
             postmenopausal for one year or surgically sterile) must use an acceptable form of&#xD;
             contraception throughout the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergy to fish oil or safflower oil (component of placebo softgels) or any component&#xD;
             of the softgel material.&#xD;
&#xD;
          2. Schirmer's test score &lt; 5 mm at Screening in either eye.&#xD;
&#xD;
          3. Tear break-up time &gt; 7 seconds at Screening or Baseline in either eye.&#xD;
&#xD;
          4. Clinically significant eyelid deformity or eyelid movement disorder that is caused by&#xD;
             conditions such as notch deformity, incomplete lid closure, entropion, ectropion,&#xD;
             hordeolum or chalazion.&#xD;
&#xD;
          5. Active seasonal and/or perennial allergic conjunctivitis or rhinitis.&#xD;
&#xD;
          6. Previous ocular disease leaving sequelae or requiring current topical eye therapy&#xD;
             other than for dry eye disease, including, but not limited to: active corneal or&#xD;
             conjunctival infection of the eye and ocular surface scarring.&#xD;
&#xD;
          7. History or presence of abnormal nasolacrimal drainage.&#xD;
&#xD;
          8. Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK)&#xD;
             performed within one year prior to Screening and throughout the study period.&#xD;
&#xD;
          9. Ophthalmic drop use within 2 hours prior to any study visit. Any over-the-counter&#xD;
             (OTC) artificial tear should be continued at the same frequency and with no change in&#xD;
             drop brand.&#xD;
&#xD;
         10. Contact lens wear within 12 hours prior to any study visit; subjects determined to&#xD;
             have worn contact lenses within 12 hours must be rescheduled.&#xD;
&#xD;
         11. Punctal cauterization or punctal plug placement within 60 days prior to Screening and&#xD;
             throughout the study period.&#xD;
&#xD;
         12. Started or changed the dose of systemic medications known to affect tear production&#xD;
             within 30 days prior to Screening and throughout the study period. These include but&#xD;
             are not limited to the following medications:&#xD;
&#xD;
               -  Immunomodulators&#xD;
&#xD;
               -  Antihistamines&#xD;
&#xD;
               -  Tricyclic antidepressants&#xD;
&#xD;
               -  Diuretics&#xD;
&#xD;
               -  Corticosteroids (intranasal, inhaled, topical dermatological, and perianal&#xD;
                  steroids are permitted).&#xD;
&#xD;
         13. Use of any topical prescription ophthalmic medications (including cyclosporine&#xD;
             [Restasis®, steroids, nonsteroidal anti-inflammatory drugs [NSAIDs], anti-glaucoma&#xD;
             medications), oral tetracyclines or topical macrolides, oral nutraceuticals [fish,&#xD;
             flax, black currant seed oils, etc.] within 21 days prior to Screening and throughout&#xD;
             the study period.&#xD;
&#xD;
         14. Chronic daily use (defined as &gt; 7 consecutive days at the recommended dosing&#xD;
             frequency) of oral NSAIDs during the study period. ANY use of oral NSAIDS during the&#xD;
             study period must be discussed with the Medical Monitor.&#xD;
&#xD;
         15. Participation in any drug or device clinical investigation within 30 days prior to&#xD;
             entry into this study and/or during the period of study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Artesia</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rancho Cordova</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Crystal River</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Deerfield Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pittsburg</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>August 19, 2019</results_first_submitted>
  <results_first_submitted_qc>August 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 11, 2019</results_first_posted>
  <last_update_submitted>November 26, 2019</last_update_submitted>
  <last_update_submitted_qc>November 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2019</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT02980224/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT02980224/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>OmegaD</title>
          <description>OmegaD Softgels&#xD;
OmegaD: OmegaD Softgels</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo Softgels&#xD;
Placebo: Placebo Softgels</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="89"/>
                <participants group_id="P2" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>OmegaD</title>
          <description>OmegaD Softgels&#xD;
OmegaD: OmegaD Softgels</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo Softgels&#xD;
Placebo: Placebo Softgels</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="89"/>
            <count group_id="B2" value="91"/>
            <count group_id="B3" value="180"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.6" spread="12.78"/>
                    <measurement group_id="B2" value="61.5" spread="12.53"/>
                    <measurement group_id="B3" value="60.6" spread="12.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Tear Break up Time(TBUT ) at Day 84</title>
        <description>The difference between Baseline (Day 1) and Day 84 in Tear Break Up Time. TBUT is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as observed via slit lamp examination.</description>
        <time_frame>Baseline and 84 Days</time_frame>
        <population>Intent to Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>OmegaD</title>
            <description>OmegaD Softgels&#xD;
OmegaD: OmegaD Softgels</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo Softgels&#xD;
Placebo: Placebo Softgels</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Tear Break up Time(TBUT ) at Day 84</title>
          <description>The difference between Baseline (Day 1) and Day 84 in Tear Break Up Time. TBUT is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as observed via slit lamp examination.</description>
          <population>Intent to Treat Population</population>
          <units>seconds</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.45" spread="0.261"/>
                    <measurement group_id="O2" value="1.23" spread="0.260"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Dry Eye Symptom Scores (OSDI Questionnaire)</title>
        <description>Difference from Baseline (Day 1) to Day 84 in the OSDI Questionnaire (dry eye symptom score). Responses evaluate a subjects experience of a symptom on the following scale:&#xD;
0 (none of the time)&#xD;
(some of the time)&#xD;
(half of the time)&#xD;
(most of the time)&#xD;
(all of the time)&#xD;
The 12 questions are as follows:&#xD;
Have you experienced any of the following during the last week:&#xD;
Eyes that are sensitive to light&#xD;
Eyes that feel gritty&#xD;
Painful or sore eyes&#xD;
Blurred vision&#xD;
Poor vision&#xD;
Have problems with your eyes limited you in performance of any of the following during the last week:&#xD;
Reading&#xD;
Driving at night&#xD;
Working with a computer or bank machine (ATM)&#xD;
Watching TV&#xD;
Have your eyes felt uncomfortable in any of the following situations during the last week:&#xD;
Windy conditions&#xD;
Places or areas with low humidity (very dry)&#xD;
Areas that are air conditioned&#xD;
A higher score means a worse outcome. The scores for the 12 questions are added together.</description>
        <time_frame>Baseline and 84 Days</time_frame>
        <population>Intent to Treat Population</population>
        <group_list>
          <group group_id="O1">
            <title>OmegaD</title>
            <description>OmegaD Softgels&#xD;
OmegaD: OmegaD Softgels</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo Softgels&#xD;
Placebo: Placebo Softgels</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Dry Eye Symptom Scores (OSDI Questionnaire)</title>
          <description>Difference from Baseline (Day 1) to Day 84 in the OSDI Questionnaire (dry eye symptom score). Responses evaluate a subjects experience of a symptom on the following scale:&#xD;
0 (none of the time)&#xD;
(some of the time)&#xD;
(half of the time)&#xD;
(most of the time)&#xD;
(all of the time)&#xD;
The 12 questions are as follows:&#xD;
Have you experienced any of the following during the last week:&#xD;
Eyes that are sensitive to light&#xD;
Eyes that feel gritty&#xD;
Painful or sore eyes&#xD;
Blurred vision&#xD;
Poor vision&#xD;
Have problems with your eyes limited you in performance of any of the following during the last week:&#xD;
Reading&#xD;
Driving at night&#xD;
Working with a computer or bank machine (ATM)&#xD;
Watching TV&#xD;
Have your eyes felt uncomfortable in any of the following situations during the last week:&#xD;
Windy conditions&#xD;
Places or areas with low humidity (very dry)&#xD;
Areas that are air conditioned&#xD;
A higher score means a worse outcome. The scores for the 12 questions are added together.</description>
          <population>Intent to Treat Population</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.39" spread="1.804"/>
                    <measurement group_id="O2" value="-15.04" spread="1.794"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Frequency and Severity of Adverse Events</title>
        <description>Number and Percentage of Subjects Reporting Adverse Events</description>
        <time_frame>84 Days</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>OmegaD</title>
            <description>OmegaD Softgels&#xD;
OmegaD: OmegaD Softgels</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo Softgels&#xD;
Placebo: Placebo Softgels</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency and Severity of Adverse Events</title>
          <description>Number and Percentage of Subjects Reporting Adverse Events</description>
          <population>Safety Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of Subjects Reporting AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects Reporting 0 AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects Reporting 1 AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Subjects Reporting &gt;1 AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of Serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects Reporting AEs leading to Discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with AEs leading to Drug Interrupti</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>84 Days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>OmegaD</title>
          <description>OmegaD Softgels&#xD;
OmegaD: OmegaD Softgels</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo Softgels&#xD;
Placebo: Placebo Softgels</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="89"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="89"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="89"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="91"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jeremy Brace, President</name_or_title>
      <organization>Brace Consulting Group Inc.</organization>
      <phone>7274582823</phone>
      <email>jbrace@braceconsultinggroup.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02980224
org study id: OmegaD-2016-001
nct id: NCT02980224
lead sponsor: 
has dmc: No
This is a phase 3 study to evaluate the safety and efficacy of OmegaD softgels for the
      treatment of dry eye disease. A daily dose of 2 OmegaD softgels dosed orally BID will be
      compared to 2 placebo softgels dosed orally BID for 84 days. Approximately 164 subjects will
      be evaluated for their signs and symptoms of dry eye disease and for safety throughout the
      study.
Inflammation is a key component of dry eye disease. Increasing the systemic levels of omega-3
      fatty acids relative to omega-6 levels can mediate immune responses. Evaluating whether
      omega-3 supplementation can improve dry eye disease signs, symptoms and associated measures
      of inflammation may present a new therapeutic option for dry eye disease.

      The primary objective of this study is to evaluate the safety and efficacy of twice daily
      (BID) dosing of OmegaD softgels in subjects with dry eye disease.

      Male and female subjects between 18 years and 90 years of age, with patient-reported dry eye
      symptoms and a clinical diagnosis of dry eye disease supported by global clinical assessment
      will be screened and enrolled. Each subject must have, in at least one eye, tear osmolarity
      of ≥ 312 mOsm/L and meibomian gland dysfunction as defined by a grade of 1 or 2 on the
      meibomian orifice size scale at both Screening and Baseline in at least one eye. In addition,
      Tear break up time (TBUT) must be ≤ 7 seconds in both eyes at both Screening and Baseline and
      the Schirmer's test score in both eye(s) must be ≥ 5 mm at Baseline.

      Approximately 164 subjects will be randomized (1:1) to 1 of 2 treatment arms and treated for
      84 days (12 weeks) with either OmegaD softgels; 2 softgels BID or placebo softgels; 2
      softgels BID. The study will be double-masked with OmegaD and placebo being
      identical-appearing softgels.

      Subjects will participate in safety and efficacy assessments throughout the study. Efficacy
      assessments will include, tear osmolarity, meibomian gland dysfunction grading, TBUT,
      Schirmer's Test, and dry eye symptoms based on the OSDI questionnaire, Safety assessments
      will include, slit lamp examination and adverse events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Tear Break up Time(TBUT ) at Day 84
time frame: Baseline and 84 Days
description: The difference between Baseline (Day 1) and Day 84 in Tear Break Up Time. TBUT is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as observed via slit lamp examination.
measure: Change From Baseline in Dry Eye Symptom Scores (OSDI Questionnaire)
time frame: Baseline and 84 Days
description: Difference from Baseline (Day 1) to Day 84 in the OSDI Questionnaire (dry eye symptom score). Responses evaluate a subjects experience of a symptom on the following scale:
0 (none of the time)
(some of the time)
(half of the time)
(most of the time)
(all of the time)
The 12 questions are as follows:
Have you experienced any of the following during the last week:
Eyes that are sensitive to light
Eyes that feel gritty
Painful or sore eyes
Blurred vision
Poor vision
Have problems with your eyes limited you in performance of any of the following during the last week:
Reading
Driving at night
Working with a computer or bank machine (ATM)
Watching TV
Have your eyes felt uncomfortable in any of the following situations during the last week:
Windy conditions
Places or areas with low humidity (very dry)
Areas that are air conditioned
A higher score means a worse outcome. The scores for the 12 questions are added together.
measure: The Frequency and Severity of Adverse Events
time frame: 84 Days
description: Number and Percentage of Subjects Reporting Adverse Events
arm group label: OmegaD
arm group type: Experimental
description: OmegaD Softgels
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Softgels
intervention type: Drug
intervention name: OmegaD
description: OmegaD Softgels
arm group label: OmegaD
intervention type: Drug
intervention name: Placebo
description: Placebo Softgels
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 