<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/NCT02254265</url>
  </required_header>
  <id_info>
    <org_study_id>OTX-101-2014-001</org_study_id>
    <nct_id>NCT02254265</nct_id>
  </id_info>
  <brief_title>Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca</brief_title>
  <official_title>A Randomized, Multicenter, Double-Masked, Vehicle-Controlled, Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Pharmaceutical Industries Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Pharmaceutical Industries Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose&#xD;
      concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo&#xD;
      (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Keratoconjunctivitis sicca (KCS) is a common multifactorial ophthalmologic disorder of the&#xD;
      tears and ocular surface characterized by symptoms of burning, stinging, itching, grittiness,&#xD;
      scratchiness, foreign body sensation, dryness, stickiness and tired eye sensation.&#xD;
&#xD;
      This study is the first clinical safety and efficacy study with OTX-101 and is designed to&#xD;
      compare two dose concentrations of OTX-101 against vehicle (placebo) in reducing the signs&#xD;
      and symptoms of KCS and evaluate safety when dosed twice a day in both eyes over an 84 day&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Conjunctival Staining</measure>
    <time_frame>Baseline to 84 days</time_frame>
    <description>Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye.&#xD;
The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Global Symptom Score</measure>
    <time_frame>Baseline to 84 days</time_frame>
    <description>Mean change from baseline at day 84 for the global symptom score.&#xD;
The freuency and severy of dry eye and irritation scores were used to calculate symptom score as follows:&#xD;
Frequency of dry eye/irritation based on a scale of 0 (rarely) to 100 (all the time) Severity of dryness or irritation based on a scale of 0 (very mildly) to 100 (very severe).&#xD;
The global symptom score was calculated as the square root of the frequency score times the severity score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tear Film Break up Time (TBUT)</measure>
    <time_frame>Baseline to 84 days</time_frame>
    <description>Mean change from baseline in TBUT in the study eye from baseline at Day 84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal Staining Score</measure>
    <time_frame>Baseline to 84 days</time_frame>
    <description>Mean Change from Baseline in Corneal Staining Score in the Study Eye. Expanded National Eye Institute Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schirmer's Test</measure>
    <time_frame>Baseline to 84 days</time_frame>
    <description>Change from Baseline in Categorized Schirmer's Test Score. Schirmer's test was performed with strips placed in both eyes at the same time. Strips were removed after 5 minutes and the amount of wetting (in mm) was recorded as scores from 1 to 5.&#xD;
1: &lt; 3 mm, 3 - 6 mm, 7 - 10 mm, 11 - 14 mm, and 5: &gt; 14 mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Baseline to 84 days</time_frame>
    <description>Patient satisfaction with treatment score using 5-point scale (1=extremely dissatisfied to 5=extremely satisfied)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">455</enrollment>
  <condition>Keratoconjunctivitis Sicca</condition>
  <condition>Dry Eye Disease</condition>
  <arm_group>
    <arm_group_label>OTX-101 0.05%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OTX-101 0.09%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OTX-101 0.05%</intervention_name>
    <description>OTX-101 0.05% Ophthalmic Solution</description>
    <arm_group_label>OTX-101 0.05%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OTX-101 0.09%</intervention_name>
    <description>OTX-101 0.09% Ophthalmic Solution</description>
    <arm_group_label>OTX-101 0.09%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Vehicle of OTX-101 Ophthalmic Solution</description>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects age 18 years or older on the date of informed consent.&#xD;
&#xD;
          2. All subjects must provide signed written consent prior to participation in any&#xD;
             study-related procedures.&#xD;
&#xD;
          3. Patient-reported history of KCS for a period of at least 6 months.&#xD;
&#xD;
          4. Clinical diagnosis of bilateral KCS supported by OTX-101-2014-001 study assessments.&#xD;
&#xD;
          5. Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible&#xD;
             score of 12 (scoring excludes superior zones 2 and 4) in the same eye at Screening and&#xD;
             Baseline.&#xD;
&#xD;
          6. Global symptom score ≥ 40 at both Screening and Baseline.&#xD;
&#xD;
          7. Corrected Snellen VA of better than 20/200 in each eye.&#xD;
&#xD;
          8. Willing to discontinue use of current dry eye therapy (including artificial tears or&#xD;
             ocular lubricants) during the study as of the run-in period.&#xD;
&#xD;
          9. Female subjects of childbearing potential must have a negative urine pregnancy test at&#xD;
             Screening. Women of childbearing potential (ie, women who are not either&#xD;
             postmenopausal for one year or surgically sterile) must use an acceptable form of&#xD;
             contraception throughout the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to&#xD;
             Screening.&#xD;
&#xD;
          2. Previous treatment failure (lack of efficacy) on cyclosporine ophthalmic emulsion&#xD;
             0.05% (Restasis).&#xD;
&#xD;
          3. Diagnosed with Sjögren's disease ˃5 years prior to Screening.&#xD;
&#xD;
          4. Clinical diagnosis of seasonal and perennial allergic conjunctivitis.&#xD;
&#xD;
          5. Use of systemic and topical medications that are known to cause dry eye within 7 days&#xD;
             prior to Screening and throughout the study period. These include the following&#xD;
             medications:&#xD;
&#xD;
               -  Immunomodulators (permitted if dose is stable for 3 months prior to screening and&#xD;
                  does not change during the study period)&#xD;
&#xD;
               -  Antihistamines (including over-the counter (OTC))&#xD;
&#xD;
               -  Cholinergics&#xD;
&#xD;
               -  Antimuscarinics&#xD;
&#xD;
               -  Tricyclic antidepressants&#xD;
&#xD;
               -  Phenothiazines&#xD;
&#xD;
               -  Retinoids&#xD;
&#xD;
          6. Oral omega-3 fatty acids (permitted if dose is stable for 3 months prior to Screening&#xD;
             and does not change during the study period)&#xD;
&#xD;
          7. Use of any topical ophthalmic medications, prescription (including antiglaucoma&#xD;
             medications) or OTC (including artificial tears), other than the assigned study&#xD;
             medication during the study period.&#xD;
&#xD;
          8. Current active eye disease other than KCS (i.e., any disease for which topical or&#xD;
             systemic ophthalmic medication is necessary).&#xD;
&#xD;
          9. History of herpes keratitis.&#xD;
&#xD;
         10. Unstable macular disease (e.g., age-related macular degeneration, diabetic&#xD;
             maculopathy). Stable macular disease is defined as no reduction in central VA within 6&#xD;
             months prior to Screening.&#xD;
&#xD;
         11. Diagnosis of chronic uveitis.&#xD;
&#xD;
         12. Corneal transplant (e.g., penetrating keratoplasty, lamellar keratoplasty, Descemet's&#xD;
             stripping endothelial keratoplasty (DSEK) ).&#xD;
&#xD;
         13. Corneal refractive surgery (e.g., laser-assisted in situ keratomileusis (LASIK]) photo&#xD;
             refractive keratectomy (PRK), limbal relaxing incision (LRI) ) within 6 months prior&#xD;
             to screening or postoperative refractive surgery symptoms of dryness that have not&#xD;
             resolved.&#xD;
&#xD;
         14. Cataract surgery within 3 months prior to Screening.&#xD;
&#xD;
         15. Non-laser glaucoma surgery at any time; glaucoma laser procedures within 3 months&#xD;
             prior to Screening.&#xD;
&#xD;
         16. Presence of punctal plugs or past history of permanent punctal occlusion (e.g.,&#xD;
             cautery).&#xD;
&#xD;
         17. Lagophthalmos or clinically significant eyelid margin irregularity of the study eye&#xD;
             whether congenital or acquired.&#xD;
&#xD;
         18. Presence of conjunctivochalasis (i.e., mechanical blockage of the lower lid punctum by&#xD;
             redundant conjunctiva).&#xD;
&#xD;
         19. Presence of pterygium in the study eye.&#xD;
&#xD;
         20. Unwilling to discontinue use of contact lenses during the duration of the study.&#xD;
&#xD;
         21. Preplanned elective surgery or hospitalization during the study period.&#xD;
&#xD;
         22. HIV-positive.&#xD;
&#xD;
         23. Unable to reliably report symptoms and history.&#xD;
&#xD;
         24. Has known hypersensitivity or contraindication to the study medication(s) or their&#xD;
             components.&#xD;
&#xD;
         25. Has a history or presence of chronic generalized systemic disease that the&#xD;
             Investigator feels might increase the risk to the subject or confound the result(s) of&#xD;
             the study.&#xD;
&#xD;
         26. Has a severe/serious ocular condition, or any other unstable medical condition that,&#xD;
             in the Investigator's opinion, may preclude study treatment or follow-up.&#xD;
&#xD;
         27. Women who are pregnant or breastfeeding.&#xD;
&#xD;
         28. Participation in any drug or device clinical investigation within 30 days prior to&#xD;
             entry into this study and/or during the period of study participation.&#xD;
&#xD;
         29. Previous randomization into this study.&#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>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>November 14, 2018</results_first_submitted>
  <results_first_submitted_qc>December 12, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 14, 2018</results_first_posted>
  <disposition_first_submitted>February 13, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>November 18, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">November 21, 2016</disposition_first_posted>
  <last_update_submitted>August 26, 2022</last_update_submitted>
  <last_update_submitted_qc>August 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Keratoconjunctivitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>OTX-101 0.05%</title>
          <description>OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution</description>
        </group>
        <group group_id="P2">
          <title>OTX-101 0.09%</title>
          <description>OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution</description>
        </group>
        <group group_id="P3">
          <title>Vehicle</title>
          <description>Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
Vehicle: Vehicle of OTX-101 Ophthalmic Solution</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="151"/>
                <participants group_id="P2" count="152"/>
                <participants group_id="P3" count="152"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="142"/>
                <participants group_id="P2" count="140"/>
                <participants group_id="P3" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to treat population</population>
      <group_list>
        <group group_id="B1">
          <title>OTX-101 0.05%</title>
          <description>OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution</description>
        </group>
        <group group_id="B2">
          <title>OTX-101 0.09%</title>
          <description>OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution</description>
        </group>
        <group group_id="B3">
          <title>Vehicle</title>
          <description>Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
Vehicle: Vehicle of OTX-101 Ophthalmic Solution</description>
        </group>
        <group group_id="B4">
          <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="151"/>
            <count group_id="B2" value="152"/>
            <count group_id="B3" value="152"/>
            <count group_id="B4" value="455"/>
          </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="61.9" spread="13.27"/>
                    <measurement group_id="B2" value="59.2" spread="14.55"/>
                    <measurement group_id="B3" value="59.3" spread="13.75"/>
                    <measurement group_id="B4" value="60.1" spread="13.90"/>
                  </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="119"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="120"/>
                    <measurement group_id="B4" value="361"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="94"/>
                  </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="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="18"/>
                  </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="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="120"/>
                    <measurement group_id="B4" value="374"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="16"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Conjunctival Staining</title>
        <description>Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye.&#xD;
The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale</description>
        <time_frame>Baseline to 84 days</time_frame>
        <population>Intent to treat population, last observed carried forward approach</population>
        <group_list>
          <group group_id="O1">
            <title>OTX-101 0.05%</title>
            <description>OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution</description>
          </group>
          <group group_id="O2">
            <title>OTX-101 0.09%</title>
            <description>OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
Vehicle: Vehicle of OTX-101 Ophthalmic Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Conjunctival Staining</title>
          <description>Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye.&#xD;
The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale</description>
          <population>Intent to treat population, last observed carried forward approach</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="151"/>
                <count group_id="O2" value="152"/>
                <count group_id="O3" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="2.17"/>
                    <measurement group_id="O2" value="-1.8" spread="2.27"/>
                    <measurement group_id="O3" value="-1.2" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Global Symptom Score</title>
        <description>Mean change from baseline at day 84 for the global symptom score.&#xD;
The freuency and severy of dry eye and irritation scores were used to calculate symptom score as follows:&#xD;
Frequency of dry eye/irritation based on a scale of 0 (rarely) to 100 (all the time) Severity of dryness or irritation based on a scale of 0 (very mildly) to 100 (very severe).&#xD;
The global symptom score was calculated as the square root of the frequency score times the severity score</description>
        <time_frame>Baseline to 84 days</time_frame>
        <population>Intent to treat population, observed data</population>
        <group_list>
          <group group_id="O1">
            <title>OTX-101 0.05%</title>
            <description>OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution</description>
          </group>
          <group group_id="O2">
            <title>OTX-101 0.09%</title>
            <description>OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
Vehicle: Vehicle of OTX-101 Ophthalmic Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Global Symptom Score</title>
          <description>Mean change from baseline at day 84 for the global symptom score.&#xD;
The freuency and severy of dry eye and irritation scores were used to calculate symptom score as follows:&#xD;
Frequency of dry eye/irritation based on a scale of 0 (rarely) to 100 (all the time) Severity of dryness or irritation based on a scale of 0 (very mildly) to 100 (very severe).&#xD;
The global symptom score was calculated as the square root of the frequency score times the severity score</description>
          <population>Intent to treat population, observed data</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="143"/>
                <count group_id="O2" value="140"/>
                <count group_id="O3" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.78" spread="23.791"/>
                    <measurement group_id="O2" value="-18.86" spread="22.810"/>
                    <measurement group_id="O3" value="-19.16" spread="22.973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tear Film Break up Time (TBUT)</title>
        <description>Mean change from baseline in TBUT in the study eye from baseline at Day 84</description>
        <time_frame>Baseline to 84 days</time_frame>
        <population>Intent to treat population - observed data</population>
        <group_list>
          <group group_id="O1">
            <title>OTX-101 0.05%</title>
            <description>OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution</description>
          </group>
          <group group_id="O2">
            <title>OTX-101 0.09%</title>
            <description>OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
Vehicle: Vehicle of OTX-101 Ophthalmic Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Tear Film Break up Time (TBUT)</title>
          <description>Mean change from baseline in TBUT in the study eye from baseline at Day 84</description>
          <population>Intent to treat population - observed data</population>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="140"/>
                <count group_id="O3" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" spread="2.032"/>
                    <measurement group_id="O2" value="0.53" spread="2.590"/>
                    <measurement group_id="O3" value="0.39" spread="2.149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Corneal Staining Score</title>
        <description>Mean Change from Baseline in Corneal Staining Score in the Study Eye. Expanded National Eye Institute Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale</description>
        <time_frame>Baseline to 84 days</time_frame>
        <population>Intent to treat population, Last observed carried forward approach</population>
        <group_list>
          <group group_id="O1">
            <title>OTX-101 0.05%</title>
            <description>OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution</description>
          </group>
          <group group_id="O2">
            <title>OTX-101 0.09%</title>
            <description>OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
Vehicle: Vehicle of OTX-101 Ophthalmic Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Corneal Staining Score</title>
          <description>Mean Change from Baseline in Corneal Staining Score in the Study Eye. Expanded National Eye Institute Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale</description>
          <population>Intent to treat population, Last observed carried forward approach</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="151"/>
                <count group_id="O2" value="152"/>
                <count group_id="O3" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="3.23"/>
                    <measurement group_id="O2" value="-1.4" spread="2.87"/>
                    <measurement group_id="O3" value="-0.6" spread="2.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Schirmer's Test</title>
        <description>Change from Baseline in Categorized Schirmer's Test Score. Schirmer's test was performed with strips placed in both eyes at the same time. Strips were removed after 5 minutes and the amount of wetting (in mm) was recorded as scores from 1 to 5.&#xD;
1: &lt; 3 mm, 3 - 6 mm, 7 - 10 mm, 11 - 14 mm, and 5: &gt; 14 mm</description>
        <time_frame>Baseline to 84 days</time_frame>
        <population>Intent to treat population (with both eyes averaged)</population>
        <group_list>
          <group group_id="O1">
            <title>OTX-101 0.05%</title>
            <description>OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution</description>
          </group>
          <group group_id="O2">
            <title>OTX-101 0.09%</title>
            <description>OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
Vehicle: Vehicle of OTX-101 Ophthalmic Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Schirmer's Test</title>
          <description>Change from Baseline in Categorized Schirmer's Test Score. Schirmer's test was performed with strips placed in both eyes at the same time. Strips were removed after 5 minutes and the amount of wetting (in mm) was recorded as scores from 1 to 5.&#xD;
1: &lt; 3 mm, 3 - 6 mm, 7 - 10 mm, 11 - 14 mm, and 5: &gt; 14 mm</description>
          <population>Intent to treat population (with both eyes averaged)</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="143"/>
                <count group_id="O2" value="140"/>
                <count group_id="O3" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" spread="1.263"/>
                    <measurement group_id="O2" value="0.37" spread="1.260"/>
                    <measurement group_id="O3" value="-0.08" spread="1.307"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction with treatment score using 5-point scale (1=extremely dissatisfied to 5=extremely satisfied)</description>
        <time_frame>Baseline to 84 days</time_frame>
        <population>Intent to treat population (Observed)</population>
        <group_list>
          <group group_id="O1">
            <title>OTX-101 0.05%</title>
            <description>OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution</description>
          </group>
          <group group_id="O2">
            <title>OTX-101 0.09%</title>
            <description>OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution</description>
          </group>
          <group group_id="O3">
            <title>Vehicle</title>
            <description>Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
Vehicle: Vehicle of OTX-101 Ophthalmic Solution</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction with treatment score using 5-point scale (1=extremely dissatisfied to 5=extremely satisfied)</description>
          <population>Intent to treat population (Observed)</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="143"/>
                <count group_id="O2" value="140"/>
                <count group_id="O3" value="144"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="1.17"/>
                    <measurement group_id="O2" value="3.7" spread="1.17"/>
                    <measurement group_id="O3" value="3.9" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>OTX-101 0.09%</title>
          <description>OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.09%: OTX-101 0.09% Ophthalmic Solution</description>
        </group>
        <group group_id="E2">
          <title>OTX-101 0.05%</title>
          <description>OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
OTX-101 0.05%: OTX-101 0.05% Ophthalmic Solution</description>
        </group>
        <group group_id="E3">
          <title>Vehicle</title>
          <description>Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days&#xD;
Vehicle: Vehicle of OTX-101 Ophthalmic Solution</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Peripheral nerve decompression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="37" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Meibomian gland dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Eye discharge</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Eyelid pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Vitreous detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="152"/>
              </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="23" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Instillation site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="152"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="152"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="152"/>
              </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 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>SPARC</name_or_title>
      <organization>Sun Pharma Advanced Research Company Limited</organization>
      <phone>+912266455645</phone>
      <email>Clinical.Trials@Sparcmail.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/NCT02254265
org study id: OTX-101-2014-001
nct id: NCT02254265
lead sponsor: 
has dmc: No
This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose
      concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo
      (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).
Keratoconjunctivitis sicca (KCS) is a common multifactorial ophthalmologic disorder of the
      tears and ocular surface characterized by symptoms of burning, stinging, itching, grittiness,
      scratchiness, foreign body sensation, dryness, stickiness and tired eye sensation.

      This study is the first clinical safety and efficacy study with OTX-101 and is designed to
      compare two dose concentrations of OTX-101 against vehicle (placebo) in reducing the signs
      and symptoms of KCS and evaluate safety when dosed twice a day in both eyes over an 84 day
      period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Conjunctival Staining
time frame: Baseline to 84 days
description: Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye.
The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale
measure: Global Symptom Score
time frame: Baseline to 84 days
description: Mean change from baseline at day 84 for the global symptom score.
The freuency and severy of dry eye and irritation scores were used to calculate symptom score as follows:
Frequency of dry eye/irritation based on a scale of 0 (rarely) to 100 (all the time) Severity of dryness or irritation based on a scale of 0 (very mildly) to 100 (very severe).
The global symptom score was calculated as the square root of the frequency score times the severity score
measure: Tear Film Break up Time (TBUT)
time frame: Baseline to 84 days
description: Mean change from baseline in TBUT in the study eye from baseline at Day 84
measure: Corneal Staining Score
time frame: Baseline to 84 days
description: Mean Change from Baseline in Corneal Staining Score in the Study Eye. Expanded National Eye Institute Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale
measure: Schirmer's Test
time frame: Baseline to 84 days
description: Change from Baseline in Categorized Schirmer's Test Score. Schirmer's test was performed with strips placed in both eyes at the same time. Strips were removed after 5 minutes and the amount of wetting (in mm) was recorded as scores from 1 to 5.
1: < 3 mm, 3 - 6 mm, 7 - 10 mm, 11 - 14 mm, and 5: > 14 mm
measure: Patient Satisfaction
time frame: Baseline to 84 days
description: Patient satisfaction with treatment score using 5-point scale (1=extremely dissatisfied to 5=extremely satisfied)
arm group label: OTX-101 0.05%
arm group type: Experimental
description: OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days
arm group label: OTX-101 0.09%
arm group type: Experimental
description: OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days
arm group label: Vehicle
arm group type: Placebo Comparator
description: Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days
intervention type: Drug
intervention name: OTX-101 0.05%
description: OTX-101 0.05% Ophthalmic Solution
arm group label: OTX-101 0.05%
intervention type: Drug
intervention name: OTX-101 0.09%
description: OTX-101 0.09% Ophthalmic Solution
arm group label: OTX-101 0.09%
intervention type: Drug
intervention name: Vehicle
description: Vehicle of OTX-101 Ophthalmic Solution
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Eye Diseases
mesh term: Keratoconjunctivitis Sicca
mesh term: Keratoconjunctivitis
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 