<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/NCT02257957</url>
  </required_header>
  <id_info>
    <org_study_id>plasmadry10</org_study_id>
    <nct_id>NCT02257957</nct_id>
  </id_info>
  <brief_title>Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye</brief_title>
  <official_title>Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Nacional de Colombia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Nacional de Colombia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dry eye is a chronic condition that decreases function and affect visual function with severe&#xD;
      discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has&#xD;
      emerged as a strategy for cellular restoration, the purpose of this study is to evaluate&#xD;
      their effects in lacrimal production and safety of this intervention in patients with severe&#xD;
      dry eye.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dry eye is a chronic condition that decreases function and affect visual function with severe&#xD;
      discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has&#xD;
      emerged as a strategy for cellular restoration, the purpose of this study is to evaluate&#xD;
      their effects in lacrimal production and safety of this intervention in patients with severe&#xD;
      dry eye.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2014</start_date>
  <completion_date type="Actual">April 20, 2016</completion_date>
  <primary_completion_date type="Actual">September 30, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Ocular Surface Staining</measure>
    <time_frame>90 days</time_frame>
    <description>Surface damage to the exposed eye, assessed by staining, is graded against standard charts. According to the Oxford grade panel (Oxford Scale), the staining was graded and was classified from grade 0 to grade V (0 to 5 score). The minimum value of this scale was 0, which indicating absent surface damage, and the maximum value was 5, which meaning severe surface damages.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Shirmer Test</measure>
    <time_frame>90 days</time_frame>
    <description>The Schirmer test I (performed without anaesthesia) was completed before any drops were instilled in the eye. Standardised Schirmer strips (Biotech Vision Care, Gandhinagar, India) were bent at the notch and placed carefully over the lower lid margin as far as possible towards the temporal angle of the lids. The patient was instructed to keep his/her eyelids closed during the test. The strips remained in place for 5 min. After 5 min, the amount of moisture in each strip was measured using a millimetre scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ocular Surface Disease Index (OSDI)</measure>
    <time_frame>90 days</time_frame>
    <description>The OSDI consists of 12 questions on items related to the assessment of symptoms, functional limitations and environmental factors related to dry eye. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. This is a valid and reliable instrument for measuring the severity of dry eye.&#xD;
The total OSDI score was then calculated by the following formula: OSDI = (sum of scores for all questions answered) × 100/(total number of questions answered) × 4). A score of 0-100 was obtained, related to the extent of dry eye, which a higher score representing greater symptoms severity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Dry Eye</condition>
  <condition>Sjogren Syndrome</condition>
  <arm_group>
    <arm_group_label>Platelet -Rich Plasma (PRP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PRP injection</intervention_name>
    <arm_group_label>Platelet -Rich Plasma (PRP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard care Hyaluronic acid eye drops</intervention_name>
    <description>: 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients with symptomatic Dry eye&#xD;
&#xD;
               -  Shirmer ≤10 mm in 5 min&#xD;
&#xD;
               -  BUT ≤10 seconds&#xD;
&#xD;
               -  Corneal staining ≥3&#xD;
&#xD;
               -  Age range: 18 years and older.&#xD;
&#xD;
               -  Both genders and all ethnic groups comparable with the local community.&#xD;
&#xD;
               -  Able to understand and willing to sign a written informed consent&#xD;
&#xD;
               -  Able and willing to cooperate with the investigational plan.&#xD;
&#xD;
               -  Able and willing to complete all mandatory follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients who are currently engaged in another clinical trial, unwilling or unable to&#xD;
             give consent, to accept randomization, or to return for scheduled visits.&#xD;
&#xD;
               -  Children under 18.&#xD;
&#xD;
               -  Pregnant women or expecting to be pregnant during the study.&#xD;
&#xD;
               -  Systemic immune deficient conditions such as AIDS or under systemic&#xD;
                  immunosuppressant.&#xD;
&#xD;
               -  Concomitant use of systemic antibiotics or steroids.&#xD;
&#xD;
               -  Contact lens wear&#xD;
&#xD;
               -  Active ocular infection or allergy&#xD;
&#xD;
               -  Unable to close eyes or uncontrolled blinking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <results_first_submitted>April 29, 2021</results_first_submitted>
  <results_first_submitted_qc>July 29, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 24, 2021</results_first_posted>
  <last_update_submitted>July 29, 2021</last_update_submitted>
  <last_update_submitted_qc>July 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</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>Sjogren's Syndrome</mesh_term>
    <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>Ophthalmic Solutions</mesh_term>
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Platelet -Rich Plasma (PRP)</title>
          <description>15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90&#xD;
PRP injection</description>
        </group>
        <group group_id="P2">
          <title>Standard Care</title>
          <description>15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90&#xD;
Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
              </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>Platelet -Rich Plasma (PRP)</title>
          <description>15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90&#xD;
PRP injection</description>
        </group>
        <group group_id="B2">
          <title>Standard Care</title>
          <description>15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90&#xD;
Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90</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="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </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="52.9" spread="3.5"/>
                    <measurement group_id="B2" value="52.7" spread="3.5"/>
                    <measurement group_id="B3" value="52.7" spread="3.5"/>
                  </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="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Ocular Surface Staining</title>
        <description>Surface damage to the exposed eye, assessed by staining, is graded against standard charts. According to the Oxford grade panel (Oxford Scale), the staining was graded and was classified from grade 0 to grade V (0 to 5 score). The minimum value of this scale was 0, which indicating absent surface damage, and the maximum value was 5, which meaning severe surface damages.</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Platelet -Rich Plasma (PRP)</title>
            <description>15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90&#xD;
PRP injection</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90&#xD;
Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ocular Surface Staining</title>
          <description>Surface damage to the exposed eye, assessed by staining, is graded against standard charts. According to the Oxford grade panel (Oxford Scale), the staining was graded and was classified from grade 0 to grade V (0 to 5 score). The minimum value of this scale was 0, which indicating absent surface damage, and the maximum value was 5, which meaning severe surface damages.</description>
          <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="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.18"/>
                    <measurement group_id="O2" value="2.4" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Shirmer Test</title>
        <description>The Schirmer test I (performed without anaesthesia) was completed before any drops were instilled in the eye. Standardised Schirmer strips (Biotech Vision Care, Gandhinagar, India) were bent at the notch and placed carefully over the lower lid margin as far as possible towards the temporal angle of the lids. The patient was instructed to keep his/her eyelids closed during the test. The strips remained in place for 5 min. After 5 min, the amount of moisture in each strip was measured using a millimetre scale</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Platelet -Rich Plasma (PRP)</title>
            <description>15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90&#xD;
PRP injection</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90&#xD;
Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Shirmer Test</title>
          <description>The Schirmer test I (performed without anaesthesia) was completed before any drops were instilled in the eye. Standardised Schirmer strips (Biotech Vision Care, Gandhinagar, India) were bent at the notch and placed carefully over the lower lid margin as far as possible towards the temporal angle of the lids. The patient was instructed to keep his/her eyelids closed during the test. The strips remained in place for 5 min. After 5 min, the amount of moisture in each strip was measured using a millimetre scale</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" spread="1"/>
                    <measurement group_id="O2" value="5.3" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ocular Surface Disease Index (OSDI)</title>
        <description>The OSDI consists of 12 questions on items related to the assessment of symptoms, functional limitations and environmental factors related to dry eye. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. This is a valid and reliable instrument for measuring the severity of dry eye.&#xD;
The total OSDI score was then calculated by the following formula: OSDI = (sum of scores for all questions answered) × 100/(total number of questions answered) × 4). A score of 0-100 was obtained, related to the extent of dry eye, which a higher score representing greater symptoms severity.</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Platelet -Rich Plasma (PRP)</title>
            <description>15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90&#xD;
PRP injection</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90&#xD;
Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ocular Surface Disease Index (OSDI)</title>
          <description>The OSDI consists of 12 questions on items related to the assessment of symptoms, functional limitations and environmental factors related to dry eye. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. This is a valid and reliable instrument for measuring the severity of dry eye.&#xD;
The total OSDI score was then calculated by the following formula: OSDI = (sum of scores for all questions answered) × 100/(total number of questions answered) × 4). A score of 0-100 was obtained, related to the extent of dry eye, which a higher score representing greater symptoms severity.</description>
          <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="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34" spread="4"/>
                    <measurement group_id="O2" value="55" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Platelet -Rich Plasma (PRP)</title>
          <description>15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90&#xD;
PRP injection</description>
        </group>
        <group group_id="E2">
          <title>Standard Care</title>
          <description>15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90&#xD;
Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr Marcel Y Avila</name_or_title>
      <organization>Universidad Nacional de Colombia</organization>
      <phone>+5713165000 ext 15119</phone>
      <email>myavilac@unal.edu.co</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/NCT02257957
org study id: plasmadry10
nct id: NCT02257957
lead sponsor: 
has dmc: Yes
Dry eye is a chronic condition that decreases function and affect visual function with severe
      discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has
      emerged as a strategy for cellular restoration, the purpose of this study is to evaluate
      their effects in lacrimal production and safety of this intervention in patients with severe
      dry eye.
Dry eye is a chronic condition that decreases function and affect visual function with severe
      discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has
      emerged as a strategy for cellular restoration, the purpose of this study is to evaluate
      their effects in lacrimal production and safety of this intervention in patients with severe
      dry eye.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Ocular Surface Staining
time frame: 90 days
description: Surface damage to the exposed eye, assessed by staining, is graded against standard charts. According to the Oxford grade panel (Oxford Scale), the staining was graded and was classified from grade 0 to grade V (0 to 5 score). The minimum value of this scale was 0, which indicating absent surface damage, and the maximum value was 5, which meaning severe surface damages.
measure: Change From Baseline in Shirmer Test
time frame: 90 days
description: The Schirmer test I (performed without anaesthesia) was completed before any drops were instilled in the eye. Standardised Schirmer strips (Biotech Vision Care, Gandhinagar, India) were bent at the notch and placed carefully over the lower lid margin as far as possible towards the temporal angle of the lids. The patient was instructed to keep his/her eyelids closed during the test. The strips remained in place for 5 min. After 5 min, the amount of moisture in each strip was measured using a millimetre scale
measure: Change From Baseline in Ocular Surface Disease Index (OSDI)
time frame: 90 days
description: The OSDI consists of 12 questions on items related to the assessment of symptoms, functional limitations and environmental factors related to dry eye. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. This is a valid and reliable instrument for measuring the severity of dry eye.
The total OSDI score was then calculated by the following formula: OSDI = (sum of scores for all questions answered) × 100/(total number of questions answered) × 4). A score of 0-100 was obtained, related to the extent of dry eye, which a higher score representing greater symptoms severity.
arm group label: Platelet -Rich Plasma (PRP)
arm group type: Experimental
description: 15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90
arm group label: Standard Care
arm group type: Active Comparator
description: 15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90
intervention type: Drug
intervention name: PRP injection
arm group label: Platelet -Rich Plasma (PRP)
intervention type: Drug
intervention name: Standard care Hyaluronic acid eye drops
description: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90
arm group label: Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Ophthalmic Solutions
mesh term: Hyaluronic Acid
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 