<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/NCT03785340</url>
  </required_header>
  <id_info>
    <org_study_id>OCU-310-301</org_study_id>
    <nct_id>NCT03785340</nct_id>
  </id_info>
  <brief_title>Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)</brief_title>
  <official_title>A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate 0.2% Nanoemulsion Eye Drops in Patients With Dry Eye Disease (DED)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ocugen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ocugen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the&#xD;
      treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half&#xD;
      will receive ophthalmic buffered saline (placebo).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dry eye disease (DED) is a common ocular disorder involving the aberrant production and&#xD;
      instability of tear film, which results in damage to the ocular surface and is correlated&#xD;
      with symptoms of ocular discomfort.&#xD;
&#xD;
      This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study&#xD;
      in the United States conducted at approximately 25 centers. Upon meeting the eligibility&#xD;
      criteria, enrolled subjects will be randomly assigned in a 1:1 (test:control) fashion to&#xD;
      receive either Brimonidine Nanoemulsion Eye Drops 0.20% investigational product (test) or&#xD;
      ophthalmic buffered saline (placebo).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">February 25, 2019</completion_date>
  <primary_completion_date type="Actual">February 25, 2019</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 to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score</measure>
    <time_frame>Baseline, 4 weeks (Day 28)</time_frame>
    <description>The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from &quot;rarely&quot; to &quot;all of the time&quot;, and the symptom severity from &quot;very mild&quot; to &quot;very severe&quot;. Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores</measure>
    <time_frame>Baseline, 4 Weeks (Day 28)</time_frame>
    <description>Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 2 Weeks (Day 14) in SANDE Score</measure>
    <time_frame>Baseline, 2 weeks (Day 14)</time_frame>
    <description>The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from &quot;rarely&quot; to &quot;all of the time&quot;, and the symptom severity from &quot;very mild&quot; to &quot;very severe&quot;. Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores</measure>
    <time_frame>Baseline, 2 Weeks (Day 14)</time_frame>
    <description>Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">252</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>OCU-310</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebos</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brimonidine Tartrate</intervention_name>
    <description>Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.</description>
    <arm_group_label>OCU-310</arm_group_label>
    <other_name>OCU-310</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.</description>
    <arm_group_label>Placebos</arm_group_label>
    <other_name>Ophthalmic buffered saline solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18 years or older.&#xD;
&#xD;
          2. Sign and date informed consent form approved by the IRB&#xD;
&#xD;
          3. History of Dry Eye Disease for ≥6 months&#xD;
&#xD;
          4. Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline&#xD;
             (Day 1):&#xD;
&#xD;
               1. Conjunctival staining at ≥3 (out of a possible score of 6 per eye), and&#xD;
&#xD;
               2. Schirmer test (with anesthesia) at ≥1 to ≤7mm in 5 minutes&#xD;
&#xD;
          5. Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at&#xD;
             Screening and Baseline (Day 1) visit&#xD;
&#xD;
          6. Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye&#xD;
&#xD;
          7. Women who satisfy one of the following:&#xD;
&#xD;
        8a. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are&#xD;
        either abstinent or sexually active on an acceptable method of birth control for at least 4&#xD;
        weeks prior to Visit 1 and throughout the study (i.e., until Day 28), OR 8b. Are&#xD;
        post-menopausal or have undergone a sterilization procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergic to brimonidine or any similar products, or excipients of brimonidine&#xD;
&#xD;
          2. Use of contact lenses within 14 days prior to Screening visit or planned use during&#xD;
             study&#xD;
&#xD;
          3. Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension&#xD;
             or history of glaucoma surgery.&#xD;
&#xD;
          4. Receiving or have received any experimental or investigational drug or device within&#xD;
             30 days prior to Screening visit&#xD;
&#xD;
          5. Intraocular pressure &lt;5 mmHg or &gt;22 mmHg in either eye&#xD;
&#xD;
          6. Active ocular infection or history of ocular herpetic keratitis&#xD;
&#xD;
          7. History of neurotrophic keratitis or ocular neuropathic pain&#xD;
&#xD;
          8. Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months&#xD;
&#xD;
          9. Punctal occlusion within 3 months prior to Screening visit or during study&#xD;
&#xD;
         10. Corneal epithelial defect larger than 1 mm2 in either eye&#xD;
&#xD;
         11. Have active drug/alcohol dependence or abuse history&#xD;
&#xD;
         12. Are neonates, pregnant/lactating women, children, or others who may be considered&#xD;
             vulnerable populations&#xD;
&#xD;
         13. Received corticosteroid-containing eye drops within 14 days prior to Screening visit&#xD;
             or planned use during study&#xD;
&#xD;
         14. Any change in systemic corticosteroids/immunosuppressives, cyclosporine ophthalmic&#xD;
             emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa™), or&#xD;
             lifitegrast ophthalmic solution 5% (Xiidra®) within 30 days prior to Screening visit&#xD;
             or planned change during study&#xD;
&#xD;
         15. In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply&#xD;
             with study protocol or unable to successfully instill eye drops&#xD;
&#xD;
         16. Disease, condition, or disorder that in the judgement of Investigator could confound&#xD;
             study assessments or limit compliance to study protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aesthetic Eye Care Institute/David Wirta, MD and Associates</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martel Medical Eye Group</name>
      <address>
        <city>Rancho Cordova</city>
        <state>California</state>
        <zip>95670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rand Eye Institute</name>
      <address>
        <city>Pompano Beach</city>
        <state>Florida</state>
        <zip>33064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Cornea Consultants</name>
      <address>
        <city>Hoffman Estates</city>
        <state>Illinois</state>
        <zip>60169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart of America Eye Care, P. A.</name>
      <address>
        <city>Mission</city>
        <state>Kansas</state>
        <zip>66204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology Associates</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Eye- Kenwood</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Eye-Montgomery</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abrams Eye Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott and Christie Eyecare Associates</name>
      <address>
        <city>Cranberry Township</city>
        <state>Pennsylvania</state>
        <zip>16066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Total Eye Care</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toyos Clinic</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midtown Eye Physicans &amp; Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Laser Vision &amp; Surgical Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revolution Research, Inc; Lake Travis Eye and Laser Center</name>
      <address>
        <city>Lakeway</city>
        <state>Texas</state>
        <zip>78734</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Eye Institute of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <results_first_submitted>April 25, 2022</results_first_submitted>
  <results_first_submitted_qc>May 24, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 6, 2022</results_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dry Eye Disease</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>Eye Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brimonidine Tartrate</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03785340/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>OCU-310</title>
          <description>Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
                <participants group_id="P2" count="126"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Study Treatment</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
                <participants group_id="P2" count="126"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="126"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized set: All randomized participants who previously signed the informed consent.</population>
      <group_list>
        <group group_id="B1">
          <title>OCU-310</title>
          <description>Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks</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="126"/>
            <count group_id="B2" value="126"/>
            <count group_id="B3" value="252"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.7" lower_limit="27" upper_limit="85"/>
                    <measurement group_id="B2" value="62.1" lower_limit="24" upper_limit="85"/>
                    <measurement group_id="B3" value="62" lower_limit="24" upper_limit="85"/>
                  </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>
              <title>Sex</title>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="211"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </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="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="229"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </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="19"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="212"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score</title>
        <description>The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from &quot;rarely&quot; to &quot;all of the time&quot;, and the symptom severity from &quot;very mild&quot; to &quot;very severe&quot;. Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
        <time_frame>Baseline, 4 weeks (Day 28)</time_frame>
        <population>The Intention-to-treat (ITT) set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed is the number of participants with evaluable data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>OCU-310</title>
            <description>Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score</title>
          <description>The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from &quot;rarely&quot; to &quot;all of the time&quot;, and the symptom severity from &quot;very mild&quot; to &quot;very severe&quot;. Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
          <population>The Intention-to-treat (ITT) set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed is the number of participants with evaluable data at each time point.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.0" spread="13.6"/>
                    <measurement group_id="O2" value="72.7" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 weeks (Day 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6" spread="23.2"/>
                    <measurement group_id="O2" value="57.2" spread="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at 4 weeks (Day 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.4" spread="20.9"/>
                    <measurement group_id="O2" value="-15.5" spread="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Four endpoints (two primary and two secondary) were to be tested in a fixed sequence, proceeding to the next endpoint until a p-value &gt;0.05 was found. The analysis of the four outcomes employed a repeated measures mixed model with mean change from baseline score at the stated time point as the response with baseline score as a covariate and treatment, visit, and their interaction as fixed effects. The least squares mean difference (OCU 310 - placebo) at the stated time point was tested.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>The endpoints were tested in a fixed sequence, proceeding to the next endpoint until a p-value &gt;0.05 was found:&#xD;
Change from baseline to 4 weeks (Day 28) in SANDE score&#xD;
Change from baseline to 4 weeks (Day 28) in Lissamine Green conjunctival staining scores&#xD;
Change from baseline to 2 weeks (Day 14) in SANDE score&#xD;
Change from baseline to 2 weeks (Day 14) in Lissamine Green conjunctival staining scores</non_inferiority_desc>
            <p_value>0.739</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <param_type>Least squares mean difference</param_type>
            <param_value>-0.844</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.823</ci_lower_limit>
            <ci_upper_limit>4.134</ci_upper_limit>
            <estimate_desc>Change from baseline to 4 weeks (Day 28) in SANDE score; OCU-310 vs. Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores</title>
        <description>Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.</description>
        <time_frame>Baseline, 4 Weeks (Day 28)</time_frame>
        <population>The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed is the number of participants with evaluable data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>OCU-310</title>
            <description>Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores</title>
          <description>Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.</description>
          <population>The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed is the number of participants with evaluable data at each time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="1.1"/>
                    <measurement group_id="O2" value="4.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Weeks (Day 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="1.6"/>
                    <measurement group_id="O2" value="3.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at 4 Weeks (Day 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.4"/>
                    <measurement group_id="O2" value="-0.9" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 2 Weeks (Day 14) in SANDE Score</title>
        <description>The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from &quot;rarely&quot; to &quot;all of the time&quot;, and the symptom severity from &quot;very mild&quot; to &quot;very severe&quot;. Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
        <time_frame>Baseline, 2 weeks (Day 14)</time_frame>
        <population>The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed are those evaluable for this Outcome Measure and the Number Analyzed per Row is the number of participants with evaluable data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>OCU-310</title>
            <description>Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 2 Weeks (Day 14) in SANDE Score</title>
          <description>The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from &quot;rarely&quot; to &quot;all of the time&quot;, and the symptom severity from &quot;very mild&quot; to &quot;very severe&quot;. Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
          <population>The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed are those evaluable for this Outcome Measure and the Number Analyzed per Row is the number of participants with evaluable data at each time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.0" spread="13.6"/>
                    <measurement group_id="O2" value="72.7" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 weeks (Day 14)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.3" spread="20.5"/>
                    <measurement group_id="O2" value="58.6" spread="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at 2 weeks (Day 14)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.6" spread="18.3"/>
                    <measurement group_id="O2" value="-14.1" spread="16.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores</title>
        <description>Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.</description>
        <time_frame>Baseline, 2 Weeks (Day 14)</time_frame>
        <population>The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed are those evaluable for this Outcome Measure and the Number Analyzed per Row is the number of participants with evaluable data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>OCU-310</title>
            <description>Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores</title>
          <description>Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.</description>
          <population>The ITT set is the primary analysis set for the efficacy endpoints and includes all randomized participants who have at least one post-baseline efficacy measurement. Here, the overall number of participants analyzed are those evaluable for this Outcome Measure and the Number Analyzed per Row is the number of participants with evaluable data at each time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="1.1"/>
                    <measurement group_id="O2" value="4.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Weeks (Day 14)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="1.4"/>
                    <measurement group_id="O2" value="3.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at 2 Weeks (Day 14)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="1.2"/>
                    <measurement group_id="O2" value="-0.7" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the time of informed consent completion, throughout the study, and at early termination (Up to 28 Days)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>OCU-310</title>
          <description>Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day (BID) for 4 weeks</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo (ophthalmic buffered saline) Eye Drops given 2 times a day (BID) for 4 weeks</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="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="126"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="126"/>
              </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>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vijay Tammara, VP, Strategic regulatory Operations</name_or_title>
      <organization>Ocugen</organization>
      <phone>484-328-4751</phone>
      <email>Vijay.tammara@ocugen.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/NCT03785340
org study id: OCU-310-301
nct id: NCT03785340
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the
      treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half
      will receive ophthalmic buffered saline (placebo).
Dry eye disease (DED) is a common ocular disorder involving the aberrant production and
      instability of tear film, which results in damage to the ocular surface and is correlated
      with symptoms of ocular discomfort.

      This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study
      in the United States conducted at approximately 25 centers. Upon meeting the eligibility
      criteria, enrolled subjects will be randomly assigned in a 1:1 (test:control) fashion to
      receive either Brimonidine Nanoemulsion Eye Drops 0.20% investigational product (test) or
      ophthalmic buffered saline (placebo).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score
time frame: Baseline, 4 weeks (Day 28)
description: The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
measure: Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores
time frame: Baseline, 4 Weeks (Day 28)
description: Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.
measure: Change From Baseline to 2 Weeks (Day 14) in SANDE Score
time frame: Baseline, 2 weeks (Day 14)
description: The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
measure: Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores
time frame: Baseline, 2 Weeks (Day 14)
description: Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.
arm group label: OCU-310
arm group type: Experimental
description: Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks
arm group label: Placebos
arm group type: Placebo Comparator
description: Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks
intervention type: Drug
intervention name: Brimonidine Tartrate
description: Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.
arm group label: OCU-310
other name: OCU-310
intervention type: Drug
intervention name: Placebos
description: Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.
arm group label: Placebos
other name: Ophthalmic buffered saline solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases
mesh term: Brimonidine Tartrate
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