<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/NCT03035864</url>
  </required_header>
  <id_info>
    <org_study_id>NGF0116</org_study_id>
    <nct_id>NCT03035864</nct_id>
  </id_info>
  <brief_title>A 8 Weeks Study to Evaluate Efficacy &amp; Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery</brief_title>
  <official_title>A 8 Weeks, Phase II, Single-centre, Randomized, Double-masked, Vehicle-controlled, Parallel Group Study With 4 Weeks Follow-up to Evaluate Efficacy &amp; Safety of rhNGF Eye Drops vs Vehicle in Patients After Cataract and Refractive Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dompé Farmaceutici S.p.A</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dompé Farmaceutici S.p.A</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this exploratory study is to assess preliminary efficacy and safety&#xD;
      of rhNGF when administered as eye drops to patients after cataract and refractive surgery.&#xD;
&#xD;
      The main criteria for evaluation were:&#xD;
&#xD;
        -  Change from baseline in SANDE scores for severity and frequency assessed at 8 weeks of&#xD;
           treatment (primary efficacy endpoint)&#xD;
&#xD;
        -  Changes in Cornea vital staining with fluorescein (National Eye Institute [NEI] scales)&#xD;
           assessed at 8 weeks of treatment (co-primary efficacy endpoint)&#xD;
&#xD;
        -  Changes in conjunctiva vital staining with fluorescein (NEI scales) (secondary efficacy&#xD;
           endpoint);&#xD;
&#xD;
        -  Changes in Tear Film Break-Up Time (TFBUT)(secondary efficacy endpoint);&#xD;
&#xD;
        -  Changes in Cochet-Bonnet corneal aesthesiometry (secondary efficacy endpoint);&#xD;
&#xD;
        -  Changes in Nerve count and morphology at scanning laser in vivo corneal confocal&#xD;
           microscopy (only patients who had Laser-Assisted In situ Keratomileusis [LASIK] surgery)&#xD;
           (secondary efficacy endpoint);&#xD;
&#xD;
        -  Changes in SANDE scores (face values) for severity and frequency (secondary efficacy&#xD;
           endpoint);&#xD;
&#xD;
        -  Incidence and frequency of treatment-emergent adverse events (TEAEs), assessed&#xD;
           throughout the study (safety endpoint).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed phase II study is a single-centre, randomized, double masked, parallel arm,&#xD;
      vehicle-controlled trial, designed to evaluate the preliminary efficacy and safety of rhNGF&#xD;
      eye drops at 20 µg/ml concentration administered six times daily for 8 weeks in patients who&#xD;
      underwent cataract and corneal refractive surgery, both known to damage the corneal sensory&#xD;
      nerve plexus.&#xD;
&#xD;
      After confirmation of inclusion and exclusion criteria all eligible patients will be&#xD;
      randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study&#xD;
      treatments administration with 4 weeks Follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2017</start_date>
  <completion_date type="Actual">September 4, 2017</completion_date>
  <primary_completion_date type="Actual">September 4, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>For the whole duration of the trial, treatment was unknown to the patient, the Investigator and the site staff.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment.</measure>
    <time_frame>Baseline and Week 8</time_frame>
    <description>The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.&#xD;
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Cornea Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)</measure>
    <time_frame>Baseline and Week 8</time_frame>
    <description>Corneal Staining was derived as the sum of scores of the five corneal sectors (central, superior, inferior, nasal, and temporal) each of which was scored on a scale of 0-3, with a minimum score of 0 and a maximal score of 15 (sum &gt; 3 out of 15 is abnormal).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)</measure>
    <time_frame>From baseline to weeks 4, 8 and 12</time_frame>
    <description>Conjunctival Staining was derived as the sum of scores of the conjunctival area (nasal-superior paralimbal, nasal-inferior paralimbal, nasal-peripheral, temporal-superior paralimbal, temporal-inferior paralimbal, temporal-peripheral) with a grading scale of 0-3 and with a minimum score of 0 and a maximal score of 18 (18 indicates the most abnormal score). Grades increase with the number and density of dots.&#xD;
Data for the main eye are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Tear Film Break-Up Time (TFBUT)</measure>
    <time_frame>From baseline to weeks 4, 8 and 12</time_frame>
    <description>The TFBUT measurement was performed after instillation of 5 microliters of 2% sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient was instructed to blink several times to thoroughly mix the fluorescein with the tear film.&#xD;
Data for the main eye are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Cochet-Bonnet Corneal Aesthesiometry</measure>
    <time_frame>From baseline to week 8</time_frame>
    <description>Corneal sensation was measured in both eyes in each of the four quadrants of the cornea using the Cochet Bonnet aesthesiometer before the instillation of any dilating or anesthetic eye drops. The handheld esthesiometer (Cochet-Bonnet) is a device that contains a thin, retractable, nylon monofilament that extends up to 6 cm in length. Variable pressure can be applied by the device by adjusting the length. The monofilament ranges from 60 mm to 5 mm and as the length is decreased the pressure increases from 11 mm/gm to 200 mm/gm.&#xD;
Data for the main eye are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in SANDE Scores (Face Values) for Frequency and Severity</measure>
    <time_frame>From baseline to weeks 4, 8 and 12</time_frame>
    <description>The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.&#xD;
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Ocular Discomfort</condition>
  <arm_group>
    <arm_group_label>rhNGF 20 µg/ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle eye drops six times daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rhNGF</intervention_name>
    <description>Eye Drop 20 μg/mL</description>
    <arm_group_label>rhNGF 20 µg/ml</arm_group_label>
    <other_name>NGF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Vehicle Eye Drop</description>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female ≥18 years old&#xD;
&#xD;
          2. Patients who are characterized by the following clinical features:&#xD;
&#xD;
               1. History of cataract or refractive corneal surgery in the study eye(s) in the&#xD;
                  previous 6 months;&#xD;
&#xD;
               2. Mean Symptom Assessment in Dry Eye (SANDE) score for severity and frequency of at&#xD;
                  least 30 at baseline&#xD;
&#xD;
          3. The same eye (study eye) must fulfill all the above criteria&#xD;
&#xD;
          4. Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units in both&#xD;
             eyes at the time of study enrolment&#xD;
&#xD;
          5. Female patients must have negative pregnancy urine test if at childbirth potential.&#xD;
&#xD;
          6. Only patients who satisfy all requirements for informed consent may be included in the&#xD;
             study. Written Informed Consent must be obtained before the initiation of any&#xD;
             study-specific procedures.&#xD;
&#xD;
          7. Patients must have the ability and willingness to comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any ocular disease other than Dry Eye requiring treatment with topical medications in&#xD;
             either eye at the time of study enrolment.&#xD;
&#xD;
          2. Any active ocular infection or active inflammation in either eye unrelated to Dry Eye.&#xD;
&#xD;
          3. Presence or history of any systemic or ocular disorder, condition or disease (with&#xD;
             particular attention to malignancies and neuro-oncological diseases) that could&#xD;
             possibly interfere with the conduct of the required study procedures or the&#xD;
             interpretation of the study results.&#xD;
&#xD;
          4. Use of therapeutic or Refractive Contact lenses in either eye at the time of study&#xD;
             enrolment;&#xD;
&#xD;
          5. History of ocular surgery in the study eye(s), excluding corneal refractive or&#xD;
             cataract procedures, within 90 days of study enrolment.&#xD;
&#xD;
          6. Females of childbearing potential (those who are not surgically sterilized or&#xD;
             post-menopausal for at least 1 year) are excluded from participation in the study if&#xD;
             they meet any one of the following conditions:&#xD;
&#xD;
               1. are currently pregnant or,&#xD;
&#xD;
               2. have a positive result at the urine pregnancy test (Baseline/Day 0) or,&#xD;
&#xD;
               3. intend to become pregnant during the study treatment period or,&#xD;
&#xD;
               4. are breast-feeding or,&#xD;
&#xD;
               5. are not willing to use highly effective birth control measures, such as: hormonal&#xD;
                  contraceptives - oral, implanted, transdermal, or injected - and/or mechanical&#xD;
                  barrier methods - spermicide in conjunction with a barrier such as a condom or&#xD;
                  diaphragm or IUD (Intrauterine device) - during the entire course of and 30 days&#xD;
                  after the study treatment periods.&#xD;
&#xD;
          7. Participation in another clinical study at the same time as the present and within 30&#xD;
             days of study enrolment;&#xD;
&#xD;
          8. History of drug, medication or alcohol abuse or addiction.&#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>Leonardo Mastropasqua, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univ. G. D'Annunzio- Clinica Oftalmologica Chieti</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univ. G. D'Annunzio-Clinica Oftalmologica-Chieti</name>
      <address>
        <city>Chieti</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <results_first_submitted>January 25, 2019</results_first_submitted>
  <results_first_submitted_qc>May 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 22, 2019</results_first_posted>
  <last_update_submitted>May 7, 2019</last_update_submitted>
  <last_update_submitted_qc>May 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ocular discomfort after cataract and refractive surgery</keyword>
  <keyword>cataract surgery</keyword>
  <keyword>refractive surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cataract</mesh_term>
    <mesh_term>Capsule Opacification</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03035864/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03035864/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Eligible patients were randomized in a 2:1 ratio to rhNGF eye drops solution at 20 μg/ml (120 patients) or vehicle eye drops solution (60 patients) 6 times per day for 8 weeks, followed by 4 weeks of follow-up with no further treatment.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>rhNGF 20 µg/ml</title>
          <description>Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily&#xD;
rhNGF: Eye Drop 20 μg/mL</description>
        </group>
        <group group_id="P2">
          <title>Vehicle</title>
          <description>Vehicle eye drops six times daily&#xD;
Vehicle: Vehicle Eye Drop</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="116"/>
                <participants group_id="P2" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysed for safety (SAF) population</population>
      <group_list>
        <group group_id="B1">
          <title>rhNGF 20 µg/ml</title>
          <description>Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily&#xD;
rhNGF: Eye Drop 20 μg/mL</description>
        </group>
        <group group_id="B2">
          <title>Vehicle</title>
          <description>Vehicle eye drops six times daily&#xD;
Vehicle: Vehicle Eye Drop</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="115"/>
            <count group_id="B2" value="59"/>
            <count group_id="B3" value="174"/>
          </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="38.0" spread="12.80"/>
                    <measurement group_id="B2" value="34.4" spread="11.20"/>
                    <measurement group_id="B3" value="36.8" spread="12.36"/>
                  </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="71"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="172"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment.</title>
        <description>The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.&#xD;
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
        <time_frame>Baseline and Week 8</time_frame>
        <population>Full Analysis Set Population. Last observation carried forward (LOCF) imputation method</population>
        <group_list>
          <group group_id="O1">
            <title>rhNGF 20 µg/ml</title>
            <description>Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily&#xD;
rhNGF: Eye Drop 20 μg/mL</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle eye drops six times daily&#xD;
Vehicle: Vehicle Eye Drop</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment.</title>
          <description>The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.&#xD;
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
          <population>Full Analysis Set Population. Last observation carried forward (LOCF) imputation method</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="112"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Frequency</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.2" spread="24.85"/>
                    <measurement group_id="O2" value="-35.7" spread="26.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.8" spread="27.20"/>
                    <measurement group_id="O2" value="-37.3" spread="20.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Frequency statistical analysis</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.974</p_value>
            <method>ANCOVA</method>
            <param_type>difference in LS means</param_type>
            <param_value>-0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.85</ci_lower_limit>
            <ci_upper_limit>6.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis related to severity</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.399</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least square means</param_type>
            <param_value>2.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.85</ci_lower_limit>
            <ci_upper_limit>9.61</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Cornea Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)</title>
        <description>Corneal Staining was derived as the sum of scores of the five corneal sectors (central, superior, inferior, nasal, and temporal) each of which was scored on a scale of 0-3, with a minimum score of 0 and a maximal score of 15 (sum &gt; 3 out of 15 is abnormal).</description>
        <time_frame>Baseline and Week 8</time_frame>
        <population>Full Analysis Set population. Last observation carried forward (LOCF) imputation method.</population>
        <group_list>
          <group group_id="O1">
            <title>rhNGF 20 µg/ml</title>
            <description>Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily&#xD;
rhNGF: Eye Drop 20 μg/mL</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle eye drops six times daily&#xD;
Vehicle: Vehicle Eye Drop</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Cornea Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)</title>
          <description>Corneal Staining was derived as the sum of scores of the five corneal sectors (central, superior, inferior, nasal, and temporal) each of which was scored on a scale of 0-3, with a minimum score of 0 and a maximal score of 15 (sum &gt; 3 out of 15 is abnormal).</description>
          <population>Full Analysis Set population. Last observation carried forward (LOCF) imputation method.</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="112"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="2.11"/>
                    <measurement group_id="O2" value="-2.2" spread="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.214</p_value>
            <method>ANCOVA</method>
            <param_type>difference in least square means</param_type>
            <param_value>0.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)</title>
        <description>Conjunctival Staining was derived as the sum of scores of the conjunctival area (nasal-superior paralimbal, nasal-inferior paralimbal, nasal-peripheral, temporal-superior paralimbal, temporal-inferior paralimbal, temporal-peripheral) with a grading scale of 0-3 and with a minimum score of 0 and a maximal score of 18 (18 indicates the most abnormal score). Grades increase with the number and density of dots.&#xD;
Data for the main eye are reported.</description>
        <time_frame>From baseline to weeks 4, 8 and 12</time_frame>
        <population>As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied. Due to the reason mentioned above, the patients actually analysed (n) were the following:&#xD;
Week 4 - 110 rhNGF; 58 vehicle Week 8 - 107 rhNGF; 58 vehicle Week 12 - 107 rhNGF; 55 vehicle</population>
        <group_list>
          <group group_id="O1">
            <title>rhNGF 20 µg/ml</title>
            <description>Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily&#xD;
rhNGF: Eye Drop 20 μg/mL</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle eye drops six times daily&#xD;
Vehicle: Vehicle Eye Drop</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)</title>
          <description>Conjunctival Staining was derived as the sum of scores of the conjunctival area (nasal-superior paralimbal, nasal-inferior paralimbal, nasal-peripheral, temporal-superior paralimbal, temporal-inferior paralimbal, temporal-peripheral) with a grading scale of 0-3 and with a minimum score of 0 and a maximal score of 18 (18 indicates the most abnormal score). Grades increase with the number and density of dots.&#xD;
Data for the main eye are reported.</description>
          <population>As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied. Due to the reason mentioned above, the patients actually analysed (n) were the following:&#xD;
Week 4 - 110 rhNGF; 58 vehicle Week 8 - 107 rhNGF; 58 vehicle Week 12 - 107 rhNGF; 55 vehicle</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="112"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.00"/>
                    <measurement group_id="O2" value="0.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Tear Film Break-Up Time (TFBUT)</title>
        <description>The TFBUT measurement was performed after instillation of 5 microliters of 2% sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient was instructed to blink several times to thoroughly mix the fluorescein with the tear film.&#xD;
Data for the main eye are reported.</description>
        <time_frame>From baseline to weeks 4, 8 and 12</time_frame>
        <population>As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied. Due to the reason mentioned above, the patients actually analysed (n) were the following:&#xD;
Week 4 - 110 rhNGF Week 8 - 107 rhNGF Week 12 - 107 rhNGF</population>
        <group_list>
          <group group_id="O1">
            <title>rhNGF 20 µg/ml</title>
            <description>Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily&#xD;
rhNGF: Eye Drop 20 μg/mL</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle eye drops six times daily&#xD;
Vehicle: Vehicle Eye Drop</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Tear Film Break-Up Time (TFBUT)</title>
          <description>The TFBUT measurement was performed after instillation of 5 microliters of 2% sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient was instructed to blink several times to thoroughly mix the fluorescein with the tear film.&#xD;
Data for the main eye are reported.</description>
          <population>As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied. Due to the reason mentioned above, the patients actually analysed (n) were the following:&#xD;
Week 4 - 110 rhNGF Week 8 - 107 rhNGF Week 12 - 107 rhNGF</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="112"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="3.07"/>
                    <measurement group_id="O2" value="2.5" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="2.96"/>
                    <measurement group_id="O2" value="2.2" spread="2.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="2.61"/>
                    <measurement group_id="O2" value="2.7" spread="2.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Cochet-Bonnet Corneal Aesthesiometry</title>
        <description>Corneal sensation was measured in both eyes in each of the four quadrants of the cornea using the Cochet Bonnet aesthesiometer before the instillation of any dilating or anesthetic eye drops. The handheld esthesiometer (Cochet-Bonnet) is a device that contains a thin, retractable, nylon monofilament that extends up to 6 cm in length. Variable pressure can be applied by the device by adjusting the length. The monofilament ranges from 60 mm to 5 mm and as the length is decreased the pressure increases from 11 mm/gm to 200 mm/gm.&#xD;
Data for the main eye are reported.</description>
        <time_frame>From baseline to week 8</time_frame>
        <population>As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied.</population>
        <group_list>
          <group group_id="O1">
            <title>rhNGF 20 µg/ml</title>
            <description>Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily&#xD;
rhNGF: Eye Drop 20 μg/mL</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle eye drops six times daily&#xD;
Vehicle: Vehicle Eye Drop</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Cochet-Bonnet Corneal Aesthesiometry</title>
          <description>Corneal sensation was measured in both eyes in each of the four quadrants of the cornea using the Cochet Bonnet aesthesiometer before the instillation of any dilating or anesthetic eye drops. The handheld esthesiometer (Cochet-Bonnet) is a device that contains a thin, retractable, nylon monofilament that extends up to 6 cm in length. Variable pressure can be applied by the device by adjusting the length. The monofilament ranges from 60 mm to 5 mm and as the length is decreased the pressure increases from 11 mm/gm to 200 mm/gm.&#xD;
Data for the main eye are reported.</description>
          <population>As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>superior nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.31"/>
                    <measurement group_id="O2" value="-0.2" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>inferior nasal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.32"/>
                    <measurement group_id="O2" value="-0.1" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>superior temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.36"/>
                    <measurement group_id="O2" value="-0.2" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>inferior temporal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.41"/>
                    <measurement group_id="O2" value="0.0" spread="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in SANDE Scores (Face Values) for Frequency and Severity</title>
        <description>The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.&#xD;
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
        <time_frame>From baseline to weeks 4, 8 and 12</time_frame>
        <population>Full Analysis Set Population. Observed values are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>rhNGF 20 µg/ml</title>
            <description>Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily&#xD;
rhNGF: Eye Drop 20 μg/mL</description>
          </group>
          <group group_id="O2">
            <title>Vehicle</title>
            <description>Vehicle eye drops six times daily&#xD;
Vehicle: Vehicle Eye Drop</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in SANDE Scores (Face Values) for Frequency and Severity</title>
          <description>The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.&#xD;
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.</description>
          <population>Full Analysis Set Population. Observed values are reported.</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="112"/>
                <count group_id="O2" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Frequency - week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.1" spread="22.37"/>
                    <measurement group_id="O2" value="-33.2" spread="25.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frequency - week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.2" spread="24.84"/>
                    <measurement group_id="O2" value="-35.7" spread="26.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frequency - week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.1" spread="22.94"/>
                    <measurement group_id="O2" value="-38.6" spread="26.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity - week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.7" spread="24.28"/>
                    <measurement group_id="O2" value="-32.9" spread="20.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity - week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.9" spread="27.51"/>
                    <measurement group_id="O2" value="-37.3" spread="20.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity - week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.5" spread="22.7"/>
                    <measurement group_id="O2" value="-38.4" spread="20.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Frequency - week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.881</p_value>
            <method>ANCOVA</method>
            <param_type>difference in least square means</param_type>
            <param_value>-0.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.13</ci_lower_limit>
            <ci_upper_limit>5.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Frequency - week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.926</p_value>
            <method>ANCOVA</method>
            <param_type>difference in least square means</param_type>
            <param_value>-0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.96</ci_lower_limit>
            <ci_upper_limit>6.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Frequency - Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.426</p_value>
            <method>ANCOVA</method>
            <param_type>difference in least square means</param_type>
            <param_value>-2.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.97</ci_lower_limit>
            <ci_upper_limit>3.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Severity - Week 4</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.828</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least square means</param_type>
            <param_value>0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.04</ci_lower_limit>
            <ci_upper_limit>6.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Severity - Week 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.394</p_value>
            <method>ANCOVA</method>
            <param_type>difference in least square means</param_type>
            <param_value>2.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.75</ci_lower_limit>
            <ci_upper_limit>9.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Severeity - Week 12</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.552</p_value>
            <method>ANCOVA</method>
            <param_type>difference in least square means</param_type>
            <param_value>-1.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.41</ci_lower_limit>
            <ci_upper_limit>3.44</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected at each time point of the study (ie. Baseline visit, Week 4, Week 8 and week 12 (follow-up visit)</time_frame>
      <desc>Overall Summary of Adverse Events is calculated on the Analysed for safety (SAF) population, i.e. 115 patients in the rhNGF group and 59 in the vehicle group.</desc>
      <group_list>
        <group group_id="E1">
          <title>rhNGF 20 µg/ml</title>
          <description>Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily&#xD;
rhNGF: Eye Drop 20 μg/mL</description>
        </group>
        <group group_id="E2">
          <title>Vehicle</title>
          <description>Vehicle eye drops six times daily&#xD;
Vehicle: Vehicle Eye Drop</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <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="115"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.9</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="115"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="33" subjects_affected="23" subjects_at_risk="115"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" events="21" subjects_affected="13" subjects_at_risk="115"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="115"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Myopia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="115"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="115"/>
                <counts group_id="E2" events="11" subjects_affected="6" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="115"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>photophobia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="115"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>foreign body sensation in eyes</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Blepharospasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Conjunctival irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Corneal epithelium defect</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Ocular discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Photopsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Eye burns</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="14" subjects_affected="9" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinalgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </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>
    <limitations_and_caveats>LImitations and caveats non specified</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Mauro P. Ferrari, Pharm D</name_or_title>
      <organization>Dompé</organization>
      <phone>02583831</phone>
      <email>info@dompe.it</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/NCT03035864
org study id: NGF0116
nct id: NCT03035864
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this exploratory study is to assess preliminary efficacy and safety
      of rhNGF when administered as eye drops to patients after cataract and refractive surgery.

      The main criteria for evaluation were:

        -  Change from baseline in SANDE scores for severity and frequency assessed at 8 weeks of
           treatment (primary efficacy endpoint)

        -  Changes in Cornea vital staining with fluorescein (National Eye Institute [NEI] scales)
           assessed at 8 weeks of treatment (co-primary efficacy endpoint)

        -  Changes in conjunctiva vital staining with fluorescein (NEI scales) (secondary efficacy
           endpoint);

        -  Changes in Tear Film Break-Up Time (TFBUT)(secondary efficacy endpoint);

        -  Changes in Cochet-Bonnet corneal aesthesiometry (secondary efficacy endpoint);

        -  Changes in Nerve count and morphology at scanning laser in vivo corneal confocal
           microscopy (only patients who had Laser-Assisted In situ Keratomileusis [LASIK] surgery)
           (secondary efficacy endpoint);

        -  Changes in SANDE scores (face values) for severity and frequency (secondary efficacy
           endpoint);

        -  Incidence and frequency of treatment-emergent adverse events (TEAEs), assessed
           throughout the study (safety endpoint).
The proposed phase II study is a single-centre, randomized, double masked, parallel arm,
      vehicle-controlled trial, designed to evaluate the preliminary efficacy and safety of rhNGF
      eye drops at 20 µg/ml concentration administered six times daily for 8 weeks in patients who
      underwent cataract and corneal refractive surgery, both known to damage the corneal sensory
      nerve plexus.

      After confirmation of inclusion and exclusion criteria all eligible patients will be
      randomized at 2:1 ratio to rhNGF or vehicle control treatment with 8 weeks of study
      treatments administration with 4 weeks Follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: For the whole duration of the trial, treatment was unknown to the patient, the Investigator and the site staff.
measure: Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment.
time frame: Baseline and Week 8
description: The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
measure: Changes in Cornea Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)
time frame: Baseline and Week 8
description: Corneal Staining was derived as the sum of scores of the five corneal sectors (central, superior, inferior, nasal, and temporal) each of which was scored on a scale of 0-3, with a minimum score of 0 and a maximal score of 15 (sum > 3 out of 15 is abnormal).
measure: Changes in Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)
time frame: From baseline to weeks 4, 8 and 12
description: Conjunctival Staining was derived as the sum of scores of the conjunctival area (nasal-superior paralimbal, nasal-inferior paralimbal, nasal-peripheral, temporal-superior paralimbal, temporal-inferior paralimbal, temporal-peripheral) with a grading scale of 0-3 and with a minimum score of 0 and a maximal score of 18 (18 indicates the most abnormal score). Grades increase with the number and density of dots.
Data for the main eye are reported.
measure: Changes in Tear Film Break-Up Time (TFBUT)
time frame: From baseline to weeks 4, 8 and 12
description: The TFBUT measurement was performed after instillation of 5 microliters of 2% sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient was instructed to blink several times to thoroughly mix the fluorescein with the tear film.
Data for the main eye are reported.
measure: Changes in Cochet-Bonnet Corneal Aesthesiometry
time frame: From baseline to week 8
description: Corneal sensation was measured in both eyes in each of the four quadrants of the cornea using the Cochet Bonnet aesthesiometer before the instillation of any dilating or anesthetic eye drops. The handheld esthesiometer (Cochet-Bonnet) is a device that contains a thin, retractable, nylon monofilament that extends up to 6 cm in length. Variable pressure can be applied by the device by adjusting the length. The monofilament ranges from 60 mm to 5 mm and as the length is decreased the pressure increases from 11 mm/gm to 200 mm/gm.
Data for the main eye are reported.
measure: Changes in SANDE Scores (Face Values) for Frequency and Severity
time frame: From baseline to weeks 4, 8 and 12
description: The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.
The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
arm group label: rhNGF 20 µg/ml
arm group type: Experimental
description: Recombinant Human Nerve Growth Factor (rhNGF) at 20 μg/mL eye drops six times daily
arm group label: Vehicle
arm group type: Placebo Comparator
description: Vehicle eye drops six times daily
intervention type: Drug
intervention name: rhNGF
description: Eye Drop 20 μg/mL
arm group label: rhNGF 20 µg/ml
other name: NGF
intervention type: Other
intervention name: Vehicle
description: Vehicle Eye Drop
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Leonardo Mastropasqua, MD
role: Principal Investigator
affiliation: Univ. G. D'Annunzio- Clinica Oftalmologica Chieti
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Cataract
mesh term: Capsule Opacification
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: LImitations and caveats non specified
point of contact: 