<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/NCT03031327</url>
  </required_header>
  <id_info>
    <org_study_id>LUB0116MD</org_study_id>
    <nct_id>NCT03031327</nct_id>
  </id_info>
  <brief_title>A 2 Weeks Study to Evaluate Tolerability, Safety, Permanence on the Ocular Surface and Efficacy of Two Concentrations of Lubricin Eye Drops Versus Sodium Hyaluronate 0.18% Eye Drops in Patients With Ocular Discomfort Following Refractive Surgery</brief_title>
  <official_title>A 2 Week, Randomized, Double-masked, Controlled, Parallel Group Study to Evaluate Tolerability, Safety, Permanence on the Ocular Surface and Efficacy of Two Concentrations of Lubricin (20 and 50 μg/mL) Eye Drops Versus Sodium Hyaluronate (HA) 0.18% Eye Drops (Vismed®) in Patients With Ocular Discomfort Following 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>
      A 2 week randomized (1:1:1), controlled, double-masked, parallel group, pre-market study.&#xD;
&#xD;
      Patients with ocular discomfort following refractive surgery procedure (within 6 months from&#xD;
      enrollment into the investigation) will be evaluated at baseline (Day 1), at Week 2 (day 15±2&#xD;
      days) and at Week 3 follow-up visit (day 22±2, or early exit).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty (30) patients (10 per arm) randomized 1:1:1 to Lubricin 20 µg/ml eye drops solution or&#xD;
      Lubricin 50 µg/ml eye drops solution or sodium hyaluronate (HA) 0.18% eye drops solution will&#xD;
      be enrolled.&#xD;
&#xD;
      As the primary objective of this study is to evaluate the tolerability and safety of Lubricin&#xD;
      (20 and 50 μg/mL) eye drops solution administered over 2 weeks in patients with ocular&#xD;
      discomfort following ocular refractive surgery, sample size was calculated based on clinical&#xD;
      feasibility and no formal sample size calculation has been performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2017</start_date>
  <completion_date type="Actual">August 10, 2017</completion_date>
  <primary_completion_date type="Actual">August 10, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tolerability using a Visual analogue scale (VAS)</measure>
    <time_frame>Day 1</time_frame>
    <description>Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tolerability using a Visual analogue scale (VAS)</measure>
    <time_frame>Day 15</time_frame>
    <description>Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tolerability using a Visual analogue scale (VAS)</measure>
    <time_frame>Day 22</time_frame>
    <description>Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>Day 15</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>Day 22</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ocular surface vital staining with Fluorescein (Oxford scale)</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular surface vital staining with Fluorescein (Oxford scale)</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ocular surface vital staining with Fluorescein (Oxford scale)</measure>
    <time_frame>Day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schirmer-I test (without anaesthesia)</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schirmer-I test (without anaesthesia)</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schirmer-I test (without anaesthesia)</measure>
    <time_frame>Day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Permanence of Lubricin on the Ocular Surface</measure>
    <time_frame>Day 1 - 15 minutes - 30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Permanence of Lubricin on the Ocular Surface</measure>
    <time_frame>Day 15 - 15 minutes - 30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Permanence of Lubricin on the Ocular Surface</measure>
    <time_frame>Day 22 - 15 minutes - 30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear film break-up time (TFBUT)</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear film break-up time (TFBUT)</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear film break-up time (TFBUT)</measure>
    <time_frame>Day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best corrected distance visual acuity</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best corrected distance visual acuity</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best corrected distance visual acuity</measure>
    <time_frame>Day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SANDE questionnaire scores - discomfort improvement entity</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SANDE questionnaire scores - discomfort improvement entity</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SANDE questionnaire scores - discomfort improvement entity</measure>
    <time_frame>Day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SANDE questionnaire scores - discomfort improvement speed</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SANDE questionnaire scores - discomfort improvement speed</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SANDE questionnaire scores - discomfort improvement speed</measure>
    <time_frame>Day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Signs evaluated by Slit lamp examination (SLE)</measure>
    <time_frame>Day 1</time_frame>
    <description>blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Signs evaluated by Slit lamp examination (SLE)</measure>
    <time_frame>Day 15</time_frame>
    <description>blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Signs evaluated by Slit lamp examination (SLE)</measure>
    <time_frame>Day 22</time_frame>
    <description>blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraocular pressure</measure>
    <time_frame>Day 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal sensitivity by Cochet-Bonnet aesthesiometry</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal sensitivity by Cochet-Bonnet aesthesiometry</measure>
    <time_frame>Day 15</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal sensitivity by Cochet-Bonnet aesthesiometry</measure>
    <time_frame>Day 22</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Ocular Discomfort</condition>
  <arm_group>
    <arm_group_label>Lubricin 20µg/ml eye drops</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lubricin 20µg/ml eye drops 3 times per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lubricin 50µg/ml eye drops</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lubricin 50µg/ml eye drops 3 times per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium hyaluronate (HA) 0.18% eye drops</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sodium hyaluronate (HA) 0.18% eye drops 3 times per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lubricin 20µg/ml eye drops</intervention_name>
    <description>Lubricin 20µg/ml eye drops 3 times per day</description>
    <arm_group_label>Lubricin 20µg/ml eye drops</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lubricin 50µg/ml eye drops</intervention_name>
    <description>Lubricin 50µg/ml eye drops 3 times per day</description>
    <arm_group_label>Lubricin 50µg/ml eye drops</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sodium hyaluronate (HA) 0.18% eye drops</intervention_name>
    <description>Sodium hyaluronate (HA) 0.18% eye drops 3 times per day</description>
    <arm_group_label>Sodium hyaluronate (HA) 0.18% eye drops</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 18 years of age or older.&#xD;
&#xD;
          2. Patients undergone ocular refractive surgery within 6 months from Day 1 Visit.&#xD;
&#xD;
          3. Patients with ocular discomfort defined as SANDE score ≥ 30 at baseline.&#xD;
&#xD;
          4. Average VAS score (dryness, foreign body sensation, burning/stinging, itching, pain,&#xD;
             stick feeling, blurred vision and photophobia) ≥ 25 mm;&#xD;
&#xD;
          5. Best corrected distance visual acuity (BCDVA) score ≥ 0.1 decimal units in both eyes&#xD;
             at the time of study enrolment.&#xD;
&#xD;
          6. Only patients who satisfy all Informed Consent requirements may be included in the&#xD;
             study. The patient and/or his/her legal representative must read, sign and date the&#xD;
             Informed Consent document before any study-related procedures are performed. The&#xD;
             Informed Consent form signed by patients and/or legal representative must have been&#xD;
             approved by the Ethics Committee for the current study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a severe Dry Eye condition (severity level 4 according to the Report of&#xD;
             the International Dry Eye Workshop -DEWS, 2007)&#xD;
&#xD;
          2. Best corrected distance visual acuity (BCDVA) score of &lt; 0.1 decimal units in either&#xD;
             eye at the time of study enrolment&#xD;
&#xD;
          3. Evidence of an active ocular infection in either eye&#xD;
&#xD;
          4. History or presence of ocular surface disorders other than ocular discomfort in either&#xD;
             eye&#xD;
&#xD;
          5. Use of any ocular topical medication other than the study medications for the&#xD;
             treatment of ocular diseases including artificial tears during the study period&#xD;
&#xD;
          6. Use of topical cyclosporine, topical corticosteroids or any other topical medication&#xD;
             for the treatment of dry eye in either eye within 30 days of study enrolment&#xD;
&#xD;
          7. History of any ocular surgery (excluding laser or refractive surgical procedures) in&#xD;
             either eye within 30 days before study enrolment. Ocular surgery will not be allowed&#xD;
             during the study treatment period and elective ocular surgery procedures should not be&#xD;
             planned during the duration of the follow-up period&#xD;
&#xD;
          8. Known hypersensitivity to one of the components of the study or procedural medications&#xD;
&#xD;
          9. Participation in another clinical study at the same time as the present study or&#xD;
             within 90 days of screening/baseline visit&#xD;
&#xD;
         10. History of drug, medication or alcohol abuse or addiction.&#xD;
&#xD;
         11. 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 on the urine pregnancy test at the Screening/Baseline&#xD;
                  Visit or,&#xD;
&#xD;
               3. intend to become pregnant during the study treatment period or,&#xD;
&#xD;
               4. are breast-feeding or,&#xD;
&#xD;
               5. 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;
      </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>Alessandro Lambiase, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università La Sapienza- Policlinico Umberto I - Rome</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Università La Sapienza- Policlinico Umberto I</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>July 24, 2018</last_update_submitted>
  <last_update_submitted_qc>July 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ocular Discomfort Following Refractive Surgery</keyword>
  <keyword>Refractive Surgery</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03031327
org study id: LUB0116MD
nct id: NCT03031327
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A 2 week randomized (1:1:1), controlled, double-masked, parallel group, pre-market study.

      Patients with ocular discomfort following refractive surgery procedure (within 6 months from
      enrollment into the investigation) will be evaluated at baseline (Day 1), at Week 2 (day 15±2
      days) and at Week 3 follow-up visit (day 22±2, or early exit).
Thirty (30) patients (10 per arm) randomized 1:1:1 to Lubricin 20 µg/ml eye drops solution or
      Lubricin 50 µg/ml eye drops solution or sodium hyaluronate (HA) 0.18% eye drops solution will
      be enrolled.

      As the primary objective of this study is to evaluate the tolerability and safety of Lubricin
      (20 and 50 μg/mL) eye drops solution administered over 2 weeks in patients with ocular
      discomfort following ocular refractive surgery, sample size was calculated based on clinical
      feasibility and no formal sample size calculation has been performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Tolerability using a Visual analogue scale (VAS)
time frame: Day 1
description: Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia
measure: Tolerability using a Visual analogue scale (VAS)
time frame: Day 15
description: Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia
measure: Tolerability using a Visual analogue scale (VAS)
time frame: Day 22
description: Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia
measure: Treatment-emergent adverse events (TEAEs)
time frame: Day 1
measure: Treatment-emergent adverse events (TEAEs)
time frame: Day 15
measure: Treatment-emergent adverse events (TEAEs)
time frame: Day 22
measure: Ocular surface vital staining with Fluorescein (Oxford scale)
time frame: Day 1
measure: Ocular surface vital staining with Fluorescein (Oxford scale)
time frame: Day 15
measure: Ocular surface vital staining with Fluorescein (Oxford scale)
time frame: Day 22
measure: Schirmer-I test (without anaesthesia)
time frame: Day 1
measure: Schirmer-I test (without anaesthesia)
time frame: Day 15
measure: Schirmer-I test (without anaesthesia)
time frame: Day 22
measure: Permanence of Lubricin on the Ocular Surface
time frame: Day 1 - 15 minutes - 30 minutes
measure: Permanence of Lubricin on the Ocular Surface
time frame: Day 15 - 15 minutes - 30 minutes
measure: Permanence of Lubricin on the Ocular Surface
time frame: Day 22 - 15 minutes - 30 minutes
measure: Tear film break-up time (TFBUT)
time frame: Day 1
measure: Tear film break-up time (TFBUT)
time frame: Day 15
measure: Tear film break-up time (TFBUT)
time frame: Day 22
measure: Best corrected distance visual acuity
time frame: Day 1
measure: Best corrected distance visual acuity
time frame: Day 15
measure: Best corrected distance visual acuity
time frame: Day 22
measure: SANDE questionnaire scores - discomfort improvement entity
time frame: Day 1
measure: SANDE questionnaire scores - discomfort improvement entity
time frame: Day 15
measure: SANDE questionnaire scores - discomfort improvement entity
time frame: Day 22
measure: SANDE questionnaire scores - discomfort improvement speed
time frame: Day 1
measure: SANDE questionnaire scores - discomfort improvement speed
time frame: Day 15
measure: SANDE questionnaire scores - discomfort improvement speed
time frame: Day 22
measure: Signs evaluated by Slit lamp examination (SLE)
time frame: Day 1
description: blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia
measure: Signs evaluated by Slit lamp examination (SLE)
time frame: Day 15
description: blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia
measure: Signs evaluated by Slit lamp examination (SLE)
time frame: Day 22
description: blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia
measure: Intraocular pressure
time frame: Day 1
measure: Intraocular pressure
time frame: Day 15
measure: Intraocular pressure
time frame: Day 22
measure: Corneal sensitivity by Cochet-Bonnet aesthesiometry
time frame: Day 1
measure: Corneal sensitivity by Cochet-Bonnet aesthesiometry
time frame: Day 15
measure: Corneal sensitivity by Cochet-Bonnet aesthesiometry
time frame: Day 22
arm group label: Lubricin 20µg/ml eye drops
arm group type: Experimental
description: Lubricin 20µg/ml eye drops 3 times per day
arm group label: Lubricin 50µg/ml eye drops
arm group type: Experimental
description: Lubricin 50µg/ml eye drops 3 times per day
arm group label: Sodium hyaluronate (HA) 0.18% eye drops
arm group type: Active Comparator
description: Sodium hyaluronate (HA) 0.18% eye drops 3 times per day
intervention type: Device
intervention name: Lubricin 20µg/ml eye drops
description: Lubricin 20µg/ml eye drops 3 times per day
arm group label: Lubricin 20µg/ml eye drops
intervention type: Device
intervention name: Lubricin 50µg/ml eye drops
description: Lubricin 50µg/ml eye drops 3 times per day
arm group label: Lubricin 50µg/ml eye drops
intervention type: Device
intervention name: Sodium hyaluronate (HA) 0.18% eye drops
description: Sodium hyaluronate (HA) 0.18% eye drops 3 times per day
arm group label: Sodium hyaluronate (HA) 0.18% eye drops
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alessandro Lambiase, MD, PhD
role: Principal Investigator
affiliation: Università La Sapienza- Policlinico Umberto I - Rome
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Ophthalmic Solutions
mesh term: Hyaluronic Acid
sharing ipd: No