<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/NCT03809611</url>
  </required_header>
  <id_info>
    <org_study_id>CUNR844A2203</org_study_id>
    <nct_id>NCT03809611</nct_id>
  </id_info>
  <brief_title>A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.</brief_title>
  <official_title>A 3-month, Randomized, Placebo-controlled, Double-masked, Multi-center Study to Evaluate the Safety and Efficacy of Topical Ocular UNR844-Cl in Subjects With Presbyopia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</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>
      The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline&#xD;
      ester chloride) ophthalmic solution on near visual function in presbyopic subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a multi-center, double-masked, placebo-controlled, randomized, parallel-group study.&#xD;
      The total duration of the study was approximately 3 months. Approximately 120 presbyopic&#xD;
      subjects were to be enrolled into the study.&#xD;
&#xD;
      Presbyopic subjects aged 45 to 55 years were the primary age group in this study.&#xD;
&#xD;
      Screening and Baseline: Subjects were screened for eligibility followed by a baseline visit&#xD;
      after which they were randomized to receive either UNR844-Cl (1.5%, equivalent to 1.3%&#xD;
      freebase) or Placebo, dosed one drop in each eye twice daily, for 3 months.&#xD;
&#xD;
      Randomized subjects attended the following study visits after baseline: at Week 2, Month 1,&#xD;
      Month 2 and Month 3.&#xD;
&#xD;
      The primary objective of this study was to assess the efficacy of UNR844-Cl on binocular&#xD;
      distance corrected near visual acuity (DCNVA) in presbyopic subjects aged 45 to 55 years with&#xD;
      the primary endpoint being the change from baseline in binocular DCNVA in subjects aged 45 to&#xD;
      55 years at Month 3 after UNR844-Cl or Placebo treatment.&#xD;
&#xD;
      There were two secondary endpoints:&#xD;
&#xD;
        1. To assess the efficacy of UNR844-Cl on achieving 75 or more Early Treatment Diabetic&#xD;
           Retinopathy Study (ETDRS) letters in binocular DCNVA in presbyopic subjects aged 45 to&#xD;
           55 years with endpoint being the proportion of subjects aged 45 to 55 years achieving 75&#xD;
           or more ETDRS letters in binocular DCNVA at Month 3 after UNR844-Cl or Placebo&#xD;
           treatment.&#xD;
&#xD;
        2. To assess the safety of UNR844-Cl in presbyopic subjects by the frequency of treatment&#xD;
           emergent adverse events (AEs) and treatment emergent serious adverse events (SAEs) in&#xD;
           all subjects after UNR844-Cl or Placebo treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 26, 2019</start_date>
  <completion_date type="Actual">December 16, 2019</completion_date>
  <primary_completion_date type="Actual">December 16, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>double-mask(Investigator, patient)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Binocular Distance-corrected Near Visual Acuity (DCNVA) From Baseline</measure>
    <time_frame>Baseline and at Month 3</time_frame>
    <description>Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number and Percentage of Subjects Aged 45 to 55 Years Achieving 75 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in Binocular DCNVA at Month 3</measure>
    <time_frame>month 3</time_frame>
    <description>Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation</measure>
    <time_frame>4 months</time_frame>
    <description>Frequency of treatment emergent adverse events and treatment emergent serious adverse events in all subjects. Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Presbyopia</condition>
  <arm_group>
    <arm_group_label>UNR844-Cl Ophthalmic Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.5% UNR844-Cl ophthalmic solution for twice-daily dosing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Ophthalmic Solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo ophthalmic solution for twice-daily dosing</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>UNR844-Cl</intervention_name>
    <description>1.5% Ophthalmic solution for topical ocular administration</description>
    <arm_group_label>UNR844-Cl Ophthalmic Solution</arm_group_label>
    <other_name>Lipoic acid choline ester chloride, EV06</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo</description>
    <arm_group_label>Placebo Ophthalmic Solution</arm_group_label>
    <other_name>Vehicle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent must be obtained before any assessment is performed&#xD;
&#xD;
          -  Impaired near vision in each eye and when using both eyes, without any near correction&#xD;
&#xD;
          -  Need a certain level of near correction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impaired distance vision in either eye, with distance correction (if any)&#xD;
&#xD;
          -  Severe short- or long-sightedness&#xD;
&#xD;
          -  Any significant medical or clinical conditions affecting vision, the eyes or general&#xD;
             health&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mission Hills</city>
        <state>California</state>
        <zip>91345</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mount Dora</city>
        <state>Florida</state>
        <zip>32757</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Washington</city>
        <state>Missouri</state>
        <zip>63090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Allenwood</city>
        <state>Pennsylvania</state>
        <zip>17810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cranberry Township</city>
        <state>Pennsylvania</state>
        <zip>16066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kingston</city>
        <state>Pennsylvania</state>
        <zip>18704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205-2013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cedar Park</city>
        <state>Texas</state>
        <zip>78613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>September 28, 2020</results_first_submitted>
  <results_first_submitted_qc>November 24, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 27, 2020</results_first_posted>
  <last_update_submitted>April 18, 2022</last_update_submitted>
  <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Presbyopia, adults, randomized study, placebo</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Presbyopia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.</ipd_description>
    <ipd_url>https://www.clinicalstudydatarequest.com/</ipd_url>
  </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>July 2, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03809611/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>January 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03809611/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>UNR844-Cl</title>
          <description>1.5% UNR844-Cl</description>
        </group>
        <group group_id="P2">
          <title>Placebo Ophthalmic Solution</title>
          <description>placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>UNR844-Cl</title>
          <description>1.5% UNR844-Cl</description>
        </group>
        <group group_id="B2">
          <title>Placebo Ophthalmic Solution</title>
          <description>placebo</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="62"/>
            <count group_id="B2" value="62"/>
            <count group_id="B3" value="124"/>
          </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="53.9" spread="4.97"/>
                    <measurement group_id="B2" value="54.2" spread="5.01"/>
                    <measurement group_id="B3" value="54.1" spread="4.97"/>
                  </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="40"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </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="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="101"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Binocular Distance-corrected Near Visual Acuity (DCNVA) From Baseline</title>
        <description>Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.</description>
        <time_frame>Baseline and at Month 3</time_frame>
        <population>All randomized subjects aged 45 to 55 years at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>UNR844-Cl</title>
            <description>1.5% UNR844-Cl</description>
          </group>
          <group group_id="O2">
            <title>Placebo Ophthalmic Solution</title>
            <description>placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Binocular Distance-corrected Near Visual Acuity (DCNVA) From Baseline</title>
          <description>Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.</description>
          <population>All randomized subjects aged 45 to 55 years at baseline</population>
          <units>number of letters read correctly</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="40"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="1.24"/>
                    <measurement group_id="O2" value="4.5" spread="1.27"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1832</p_value>
            <p_value_desc>One-sided p-value for treatment difference</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.77</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.34</ci_lower_limit>
            <ci_upper_limit>4.56</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Percentage of Subjects Aged 45 to 55 Years Achieving 75 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in Binocular DCNVA at Month 3</title>
        <description>Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.</description>
        <time_frame>month 3</time_frame>
        <population>l randomized subjects aged 45 to 55 years at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>UNR844-Cl</title>
            <description>1.5% UNR844-Cl</description>
          </group>
          <group group_id="O2">
            <title>Placebo Ophthalmic Solution</title>
            <description>placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Percentage of Subjects Aged 45 to 55 Years Achieving 75 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in Binocular DCNVA at Month 3</title>
          <description>Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.</description>
          <population>l randomized subjects aged 45 to 55 years at baseline</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="40"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2830</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>4.78</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation</title>
        <description>Frequency of treatment emergent adverse events and treatment emergent serious adverse events in all subjects. Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.</description>
        <time_frame>4 months</time_frame>
        <population>All randomized and treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>UNR844-Cl</title>
            <description>1.5% UNR844-Cl</description>
          </group>
          <group group_id="O2">
            <title>Placebo Ophthalmic Solution</title>
            <description>placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation</title>
          <description>Frequency of treatment emergent adverse events and treatment emergent serious adverse events in all subjects. Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.</description>
          <population>All randomized and treated participants</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="62"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any adverse events (AEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any ocular adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any non-ocular adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any severe adverse events</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>Any ocular severe adverse events</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>Any non-ocular severe adverse events</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>Any study drug related adverse events</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>Any study drug related ocular adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any study drug related non-ocular adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any adverse events leading to study drug disc.</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>Any ocular AEs leading to study drug disc.</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>Any non-ocular AEs leading to study drug disc.</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>Any serious adverse events</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>Any ocular serious adverse events</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>Any non-ocular serious adverse events</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>Any study drug related serious adverse events</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>Any study drug related ocular 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>Any study drug related non-ocular 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>Death</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>Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>UNR844-Cl</title>
          <description>UNR844-Cl</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo</description>
        </group>
        <group group_id="E3">
          <title>Total</title>
          <description>Total</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="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (22.1)</default_vocab>
        <default_assessment>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="14" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Conjunctival hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Lenticular opacities</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Instillation site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Sensation of foreign body</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Chemical burns of eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Vital dye staining cornea present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="124"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="124"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="62"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="62"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="124"/>
              </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>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>+ 1 862 778 8300</phone>
      <email>Novartis.email@Novartis.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/NCT03809611
org study id: CUNR844A2203
nct id: NCT03809611
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline
      ester chloride) ophthalmic solution on near visual function in presbyopic subjects.
This was a multi-center, double-masked, placebo-controlled, randomized, parallel-group study.
      The total duration of the study was approximately 3 months. Approximately 120 presbyopic
      subjects were to be enrolled into the study.

      Presbyopic subjects aged 45 to 55 years were the primary age group in this study.

      Screening and Baseline: Subjects were screened for eligibility followed by a baseline visit
      after which they were randomized to receive either UNR844-Cl (1.5%, equivalent to 1.3%
      freebase) or Placebo, dosed one drop in each eye twice daily, for 3 months.

      Randomized subjects attended the following study visits after baseline: at Week 2, Month 1,
      Month 2 and Month 3.

      The primary objective of this study was to assess the efficacy of UNR844-Cl on binocular
      distance corrected near visual acuity (DCNVA) in presbyopic subjects aged 45 to 55 years with
      the primary endpoint being the change from baseline in binocular DCNVA in subjects aged 45 to
      55 years at Month 3 after UNR844-Cl or Placebo treatment.

      There were two secondary endpoints:

        1. To assess the efficacy of UNR844-Cl on achieving 75 or more Early Treatment Diabetic
           Retinopathy Study (ETDRS) letters in binocular DCNVA in presbyopic subjects aged 45 to
           55 years with endpoint being the proportion of subjects aged 45 to 55 years achieving 75
           or more ETDRS letters in binocular DCNVA at Month 3 after UNR844-Cl or Placebo
           treatment.

        2. To assess the safety of UNR844-Cl in presbyopic subjects by the frequency of treatment
           emergent adverse events (AEs) and treatment emergent serious adverse events (SAEs) in
           all subjects after UNR844-Cl or Placebo treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: double-mask(Investigator, patient)
measure: Change in Binocular Distance-corrected Near Visual Acuity (DCNVA) From Baseline
time frame: Baseline and at Month 3
description: Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.
measure: Number and Percentage of Subjects Aged 45 to 55 Years Achieving 75 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in Binocular DCNVA at Month 3
time frame: month 3
description: Change from baseline in binocular DCNVA in subjects aged 45 to 55 years at Month 3 after UNR844-Cl or placebo treatment. Low contrast (10% contrast) DCNVA at 40 cm is measured binocularly using an electronic visual acuity testing system. This assessment was performed with subjects corrected for any distance refractive errors. The system provided distance-corrected low contrast near visual acuity in an Early Treatment Diabetic Retinopathy Study (ETDRS) letter numerical score. High monocular DCNVA ETDRS letter scores represent good vision; Low monocular DCNVA ETDRS letter scores represent poor vision.
measure: Number of Subjects With Adverse Events, Ocular Adverse Events, Deaths, Other Serious Adverse Events, or Adverse Events Leading to Study Drug Discontinuation
time frame: 4 months
description: Frequency of treatment emergent adverse events and treatment emergent serious adverse events in all subjects. Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 120 days.
arm group label: UNR844-Cl Ophthalmic Solution
arm group type: Experimental
description: 1.5% UNR844-Cl ophthalmic solution for twice-daily dosing
arm group label: Placebo Ophthalmic Solution
arm group type: Placebo Comparator
description: placebo ophthalmic solution for twice-daily dosing
intervention type: Drug
intervention name: UNR844-Cl
description: 1.5% Ophthalmic solution for topical ocular administration
arm group label: UNR844-Cl Ophthalmic Solution
other name: Lipoic acid choline ester chloride, EV06
intervention type: Drug
intervention name: Placebo
description: placebo
arm group label: Placebo Ophthalmic Solution
other name: Vehicle
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Presbyopia
mesh term: Choline
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
ipd url: https://www.clinicalstudydatarequest.com/
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