<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/NCT02199964</url>
  </required_header>
  <id_info>
    <org_study_id>H-33276</org_study_id>
    <nct_id>NCT02199964</nct_id>
  </id_info>
  <brief_title>The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface</brief_title>
  <acronym>CsA</acronym>
  <official_title>The Effects of Cyclosporin A Emulsion, (Restasis), on the Ocular Surface in Response to Low Humidity Environment in Patients With Dry Eye</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will test that hypothesis that topical administration of the FDA approved&#xD;
      immunomodulatory agent cyclosporin A emulsion will minimize irritation and ocular surface&#xD;
      disease that results from a short term low humidity environmental stress&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study designed to evaluate the effect of two conventional dry eye therapies,&#xD;
      artificial tears to hydrate and cyclosporine A as an anti-inflammatory, on the irritation&#xD;
      symptoms and ocular surface disease of dry eye patients who will be exposed to a low humidity&#xD;
      environment for 90 minutes. Patients with dry eye will be enrolled in this study and complete&#xD;
      a validated symptom questionnaire and then undergo a complete ocular surface and tear&#xD;
      examination to characterize their disease. Enrolled subjects will be exposed to a low&#xD;
      humidity environment at the initial evaluation prior to any treatment and will be exposed to&#xD;
      a low humidity environment for a second time. They will be randomized to receive either&#xD;
      artificial tears or 0.05% cyclosporine A emulsion drop four times a day for 6 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding was terminated&#xD;
  </why_stopped>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Corneal Fluorescein Staining</measure>
    <time_frame>6 weeks</time_frame>
    <description>The mean difference in corneal staining using the adjusted CCLR global staining score before and after the environmental challenge at visits baseline and Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Corneal fluorescein staining was graded 0-100 in 5 zones on the cornea. The scores ranged from 0 (minimum) to 500 (maximum). A higher score indicates there was greater cornea disease induced by the low humidity stress on Day 42</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eye Irritation Symptoms</measure>
    <time_frame>6 weeks</time_frame>
    <description>The mean difference in subject's scoring of eye irritation symptoms using a VAS (visual analog scale) questionnaire before and after the environmental challenge after treatment at Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Symptoms were graded on a 4 question VAS 0-5 for each question, with scores summed for all questions for a total score that ranges from 0 (minimum) to 20 (maximum) for the pre and post challenge questionnaires. The outcome measure is the difference in the post to pre total score ranging from -20 (maximum improvement) to 20 (maximum worsening). A minus difference indicated the subject had lower irritation symptoms following the lower humidity challenge, while a positive difference indicated the subject had greater irritation following the low humidity challenge on Day 42.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Conjunctival Goblet Cells</measure>
    <time_frame>6 weeks</time_frame>
    <description>The number of conjunctival goblet cells measured in impression cytology at screening/baseline before and after low humidity exposure at the baseline and Day 42 visits. No (zero) subjects were analyzed because the assay was not performed and data was not collected because the study was terminated due to loss of funding.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>Cyclosporin 0.05% emulsion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>used in the eye 4 times a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endura Refresh, Artificial Tears</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Over the Counter artificial tears used in the eye 4 times a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclosporin 0.05% emulsion</intervention_name>
    <description>Topical therapy for dry eye</description>
    <arm_group_label>Cyclosporin 0.05% emulsion</arm_group_label>
    <other_name>Artificial tears</other_name>
    <other_name>Cyclosporin 0.05% emulsion (Restasis)</other_name>
    <other_name>Dry Eyes</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endura, Refresh artificial tears</intervention_name>
    <description>Over the counter therapy for dry eye, used 4 times a day</description>
    <arm_group_label>Endura Refresh, Artificial Tears</arm_group_label>
    <other_name>Dry Eyes</other_name>
    <other_name>Artificial Tears</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signature on the written informed consent form&#xD;
&#xD;
          -  Patient willingness and ability to return for all visits during the study&#xD;
&#xD;
          -  Rapid tear film break up time of seven seconds or less in at least one eye AND&#xD;
&#xD;
          -  Both cornea fluorescein staining score greater than or equal to 3 and conjunctival&#xD;
             lissamine green staining greater than or equal to 3 in at least one eye&#xD;
&#xD;
          -  Ocular Surface Disease Index Symptom Severity score of twenty or greater&#xD;
&#xD;
          -  Tear meniscus height less than or equal to 230um&#xD;
&#xD;
          -  Intact corneal sensitivity&#xD;
&#xD;
          -  Willingness to discontinue use of any current dry eye treatment (except artificial&#xD;
             tears) for four weeks prior to enrollment, and during the course of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Compromised cognitive ability which may be expected to interfere with study compliance&#xD;
&#xD;
          -  Uncontrolled or poorly controlled diabetes or heart or pulmonary disease that could,&#xD;
             in the judgment of the investigator, jeopardize subject safety or interfere with the&#xD;
             interpretation of the results of the study&#xD;
&#xD;
          -  Known hypersensitivity to any components of the artificial tears or cyclosporin A eye&#xD;
             drops Anticipated contact lens wear during the study&#xD;
&#xD;
          -  History of corneal transplant&#xD;
&#xD;
          -  Active ocular infection, uveitis or non-KCS related inflammation&#xD;
&#xD;
          -  History of cataract surgery within 3 months prior to enrollment&#xD;
&#xD;
          -  History of pterygium removal within 6 months prior to enrollment&#xD;
&#xD;
          -  Reduced corneal sensitivity&#xD;
&#xD;
          -  Initiation, discontinuation or change in dosage of hormone replacement therapy (HRT),&#xD;
             fish oil, evening primrose, flaxseed, or black current seed oil supplements,&#xD;
             antihistamines, cholinergic agents, beta-blocking agents, tricyclic or SSRI&#xD;
             antidepressants, phenothiazines, or topical or systemic acne rosacea medications in&#xD;
             two months prior to enrollment, or anticipated change in dosage during course of study&#xD;
&#xD;
          -  Topical ophthalmic medications within prior 4 weeks, or anticipated use of same during&#xD;
             the study (except artificial tears)&#xD;
&#xD;
          -  Occlusion of the lacrimal puncta either surgically or with temporary collagen punctal&#xD;
             plugs within three months prior to study, or anticipated use of same during 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>
  <overall_official>
    <last_name>Stephen C. Pflugfelder, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine, Department of Ophthalmology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alkek Eye Center, Dept of Ophthalmology, Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Alex A, Edwards A, Hays JD, Kerkstra M, Shih A, de Paiva CS, Pflugfelder SC. Factors predicting the ocular surface response to desiccating environmental stress. Invest Ophthalmol Vis Sci. 2013 May 7;54(5):3325-32. doi: 10.1167/iovs.12-11322.</citation>
    <PMID>23572103</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <results_first_submitted>February 21, 2017</results_first_submitted>
  <results_first_submitted_qc>January 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 5, 2020</results_first_posted>
  <last_update_submitted>February 12, 2020</last_update_submitted>
  <last_update_submitted_qc>February 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Steven Pflugfelder</investigator_full_name>
    <investigator_title>Director of Ocular Surface Clinical Trials</investigator_title>
  </responsible_party>
  <keyword>Dry eye</keyword>
  <keyword>environmental stress</keyword>
  <keyword>artificial tears</keyword>
  <keyword>cyclosporin</keyword>
  <keyword>Restasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclosporine</mesh_term>
    <mesh_term>Lubricant Eye Drops</mesh_term>
    <mesh_term>Cyclosporins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The study was terminated early because of loss of funding.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment process occurred at the medical clinic of the primary investigator. Recruitment began July 2014 and ended December 2015.</recruitment_details>
      <pre_assignment_details>There were no pre-assignment details.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cyclosporin 0.05% Emulsion</title>
          <description>used in the eye 4 times a day&#xD;
Cyclosporin 0.05% emulsion: Topical therapy for dry eye</description>
        </group>
        <group group_id="P2">
          <title>Endura Refresh, Artificial Tears</title>
          <description>Over the Counter artificial tears used in the eye 4 times a day&#xD;
Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cyclosporin 0.05% Emulsion</title>
          <description>used in the eye 4 times a day&#xD;
Cyclosporin 0.05% emulsion: Topical therapy for dry eye</description>
        </group>
        <group group_id="B2">
          <title>Endura Refresh, Artificial Tears</title>
          <description>Over the Counter artificial tears used in the eye 4 times a day&#xD;
Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day</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="2"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="51" spread="9.9"/>
                    <measurement group_id="B2" value="58" spread="4.2"/>
                    <measurement group_id="B3" value="54.5" spread="7.4"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Corneal Fluorescein Staining</title>
        <description>The mean difference in corneal staining using the adjusted CCLR global staining score before and after the environmental challenge at visits baseline and Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Corneal fluorescein staining was graded 0-100 in 5 zones on the cornea. The scores ranged from 0 (minimum) to 500 (maximum). A higher score indicates there was greater cornea disease induced by the low humidity stress on Day 42</description>
        <time_frame>6 weeks</time_frame>
        <population>Due to loss of funding, this study was not completed and enrollment ended. Data from only 2 subjects per group was analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Cyclosporin 0.05% Emulsion</title>
            <description>used in the eye 4 times a day&#xD;
Cyclosporin 0.05% emulsion: Topical therapy for dry eye</description>
          </group>
          <group group_id="O2">
            <title>Endura Refresh, Artificial Tears</title>
            <description>Over the Counter artificial tears used in the eye 4 times a day&#xD;
Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day</description>
          </group>
        </group_list>
        <measure>
          <title>Corneal Fluorescein Staining</title>
          <description>The mean difference in corneal staining using the adjusted CCLR global staining score before and after the environmental challenge at visits baseline and Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Corneal fluorescein staining was graded 0-100 in 5 zones on the cornea. The scores ranged from 0 (minimum) to 500 (maximum). A higher score indicates there was greater cornea disease induced by the low humidity stress on Day 42</description>
          <population>Due to loss of funding, this study was not completed and enrollment ended. Data from only 2 subjects per group was analyzed</population>
          <units>units 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="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5" spread="13.44"/>
                    <measurement group_id="O2" value="29" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eye Irritation Symptoms</title>
        <description>The mean difference in subject's scoring of eye irritation symptoms using a VAS (visual analog scale) questionnaire before and after the environmental challenge after treatment at Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Symptoms were graded on a 4 question VAS 0-5 for each question, with scores summed for all questions for a total score that ranges from 0 (minimum) to 20 (maximum) for the pre and post challenge questionnaires. The outcome measure is the difference in the post to pre total score ranging from -20 (maximum improvement) to 20 (maximum worsening). A minus difference indicated the subject had lower irritation symptoms following the lower humidity challenge, while a positive difference indicated the subject had greater irritation following the low humidity challenge on Day 42.</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cyclosporin 0.05% Emulsion</title>
            <description>used in the eye 4 times a day&#xD;
Cyclosporin 0.05% emulsion: Topical therapy for dry eye</description>
          </group>
          <group group_id="O2">
            <title>Endura Refresh, Artificial Tears</title>
            <description>Over the Counter artificial tears used in the eye 4 times a day&#xD;
Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day</description>
          </group>
        </group_list>
        <measure>
          <title>Eye Irritation Symptoms</title>
          <description>The mean difference in subject's scoring of eye irritation symptoms using a VAS (visual analog scale) questionnaire before and after the environmental challenge after treatment at Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Symptoms were graded on a 4 question VAS 0-5 for each question, with scores summed for all questions for a total score that ranges from 0 (minimum) to 20 (maximum) for the pre and post challenge questionnaires. The outcome measure is the difference in the post to pre total score ranging from -20 (maximum improvement) to 20 (maximum worsening). A minus difference indicated the subject had lower irritation symptoms following the lower humidity challenge, while a positive difference indicated the subject had greater irritation following the low humidity challenge on Day 42.</description>
          <units>units 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="2"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="2.1"/>
                    <measurement group_id="O2" value="1" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Conjunctival Goblet Cells</title>
        <description>The number of conjunctival goblet cells measured in impression cytology at screening/baseline before and after low humidity exposure at the baseline and Day 42 visits. No (zero) subjects were analyzed because the assay was not performed and data was not collected because the study was terminated due to loss of funding.</description>
        <time_frame>6 weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected up to 6 months until study termination.</time_frame>
      <desc>Adverse event collection was done at each subject visit.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cyclosporin 0.05% Emulsion</title>
          <description>used in the eye 4 times a day&#xD;
Cyclosporin 0.05% emulsion: Topical therapy for dry eye</description>
        </group>
        <group group_id="E2">
          <title>Endura Refresh, Artificial Tears</title>
          <description>Over the Counter artificial tears used in the eye 4 times a day&#xD;
Endura, Refresh artificial tears: Over the counter therapy for dry eye, used 4 times a day</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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Stephen Pflugfelder, M.D.</name_or_title>
      <organization>Baylor College of Medicine</organization>
      <phone>713-798-6100</phone>
      <email>stevenp@bcm.edu</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/NCT02199964
org study id: H-33276
nct id: NCT02199964
lead sponsor: 
collaborator: 
has dmc: No
This study will test that hypothesis that topical administration of the FDA approved
      immunomodulatory agent cyclosporin A emulsion will minimize irritation and ocular surface
      disease that results from a short term low humidity environmental stress
This is a pilot study designed to evaluate the effect of two conventional dry eye therapies,
      artificial tears to hydrate and cyclosporine A as an anti-inflammatory, on the irritation
      symptoms and ocular surface disease of dry eye patients who will be exposed to a low humidity
      environment for 90 minutes. Patients with dry eye will be enrolled in this study and complete
      a validated symptom questionnaire and then undergo a complete ocular surface and tear
      examination to characterize their disease. Enrolled subjects will be exposed to a low
      humidity environment at the initial evaluation prior to any treatment and will be exposed to
      a low humidity environment for a second time. They will be randomized to receive either
      artificial tears or 0.05% cyclosporine A emulsion drop four times a day for 6 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Corneal Fluorescein Staining
time frame: 6 weeks
description: The mean difference in corneal staining using the adjusted CCLR global staining score before and after the environmental challenge at visits baseline and Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Corneal fluorescein staining was graded 0-100 in 5 zones on the cornea. The scores ranged from 0 (minimum) to 500 (maximum). A higher score indicates there was greater cornea disease induced by the low humidity stress on Day 42
measure: Eye Irritation Symptoms
time frame: 6 weeks
description: The mean difference in subject's scoring of eye irritation symptoms using a VAS (visual analog scale) questionnaire before and after the environmental challenge after treatment at Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Symptoms were graded on a 4 question VAS 0-5 for each question, with scores summed for all questions for a total score that ranges from 0 (minimum) to 20 (maximum) for the pre and post challenge questionnaires. The outcome measure is the difference in the post to pre total score ranging from -20 (maximum improvement) to 20 (maximum worsening). A minus difference indicated the subject had lower irritation symptoms following the lower humidity challenge, while a positive difference indicated the subject had greater irritation following the low humidity challenge on Day 42.
measure: Conjunctival Goblet Cells
time frame: 6 weeks
description: The number of conjunctival goblet cells measured in impression cytology at screening/baseline before and after low humidity exposure at the baseline and Day 42 visits. No (zero) subjects were analyzed because the assay was not performed and data was not collected because the study was terminated due to loss of funding.
arm group label: Cyclosporin 0.05% emulsion
arm group type: Experimental
description: used in the eye 4 times a day
arm group label: Endura Refresh, Artificial Tears
arm group type: Active Comparator
description: Over the Counter artificial tears used in the eye 4 times a day
intervention type: Drug
intervention name: Cyclosporin 0.05% emulsion
description: Topical therapy for dry eye
arm group label: Cyclosporin 0.05% emulsion
other name: Artificial tears
other name: Cyclosporin 0.05% emulsion (Restasis)
other name: Dry Eyes
intervention type: Drug
intervention name: Endura, Refresh artificial tears
description: Over the counter therapy for dry eye, used 4 times a day
arm group label: Endura Refresh, Artificial Tears
other name: Dry Eyes
other name: Artificial Tears
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen C. Pflugfelder, MD
role: Principal Investigator
affiliation: Baylor College of Medicine, Department of Ophthalmology
facility: 
country: United States
citation: Alex A, Edwards A, Hays JD, Kerkstra M, Shih A, de Paiva CS, Pflugfelder SC. Factors predicting the ocular surface response to desiccating environmental stress. Invest Ophthalmol Vis Sci. 2013 May 7;54(5):3325-32. doi: 10.1167/iovs.12-11322.
PMID: 23572103
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Steven Pflugfelder
investigator title: Director of Ocular Surface Clinical Trials
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Cyclosporine
mesh term: Lubricant Eye Drops
mesh term: Cyclosporins
sharing ipd: No
ipd description: The study was terminated early because of loss of funding.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 