<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/NCT01735045</url>
  </required_header>
  <id_info>
    <org_study_id>HF-2010-01</org_study_id>
    <nct_id>NCT01735045</nct_id>
  </id_info>
  <brief_title>LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear</brief_title>
  <official_title>LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szabocsik and Associates, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Szabocsik and Associates, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft&#xD;
      contact lenses when used as a daily wear contact lens for the correction of myopia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>3 months</time_frame>
    <description>Snelling Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Slit Lamp Findings</measure>
    <time_frame>3 months</time_frame>
    <description>Grading by the Slit Lamp Classification Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Myopia</condition>
  <arm_group>
    <arm_group_label>Test Group myopia control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects wearing contact lenses made of LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for myopia control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Myopia Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects wearing Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens for myopia control</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens</intervention_name>
    <description>Daily Wear</description>
    <arm_group_label>Test Group myopia control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens</intervention_name>
    <arm_group_label>Myopia Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have been advised that the contact lenses they will be wearing for the next 3 months&#xD;
             are being used for investigational purposes and that their informed consent will be&#xD;
             needed and documented prior to the start of the study.&#xD;
&#xD;
          -  Visual acuity must be correctable to 20/30, with spherical lenses ranging in power&#xD;
             from -1.00 to -5.00D, astigmatism≤1.50D.&#xD;
&#xD;
          -  Have been successfully wearing soft (hydrophilic) contact lenses for at least one&#xD;
             month prior to entering the study. (Success means both subject and practitioner are&#xD;
             satisfied with visual acuity, comfort, and ocular physiology).&#xD;
&#xD;
          -  Have non-diseased eyes which are normal or which have no preexisting ocular condition&#xD;
             which would interfere with the patient's ability to adapt to the new pair of LSH&#xD;
             Silicone Hydrogel Soft (hydrophilic) Contact Lenses. A normal eye is defined as one&#xD;
             having all the following characteristics:&#xD;
&#xD;
               1. No evidence of lid infection.&#xD;
&#xD;
               2. No structural lid abnormality.&#xD;
&#xD;
               3. No conjunctival abnormality or infection.&#xD;
&#xD;
               4. A cornea which is clear with no edema, staining, vascularization or abnormal&#xD;
                  opacities, all as observed by slit lamp examination.&#xD;
&#xD;
               5. No iritis.&#xD;
&#xD;
               6. No other active ocular disease that would contraindicate use of the&#xD;
                  investigational lens.&#xD;
&#xD;
               7. No GPC (giant papillary conjunctivitis, tarsal abnormality) Grade 2 or greater&#xD;
&#xD;
          -  Use no ocular medication.&#xD;
&#xD;
          -  Have no known sensitivity to solutions currently used for contact lens care.&#xD;
&#xD;
          -  Have binocular correction with contact lenses.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Astigmatism &gt;1.50D&#xD;
&#xD;
          -  No monocular or monovision fits may be included.&#xD;
&#xD;
          -  Pregnant and lactating women are excluded from the study&#xD;
&#xD;
          -  Minors (under age 18) are excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John M Szabocsik, PhD</last_name>
    <role>Study Director</role>
  </overall_official>
  <location>
    <facility>
      <name>Glenda Secor, OD</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Randall Sakamoto</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert Davis, OD</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Douglas P. Benoit, OD, FAAO</name>
      <address>
        <city>Concord</city>
        <state>New Hampshire</state>
        <zip>03301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stephen P. Byrnes, OD, FAAO</name>
      <address>
        <city>Londonderry</city>
        <state>New Hampshire</state>
        <zip>03053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>June 11, 2012</study_first_submitted>
  <study_first_submitted_qc>November 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 25, 2012</last_update_submitted>
  <last_update_submitted_qc>November 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myopia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01735045
org study id: HF-2010-01
nct id: NCT01735045
lead sponsor: 
has dmc: Yes
This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft
      contact lenses when used as a daily wear contact lens for the correction of myopia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Acuity
time frame: 3 months
description: Snelling Scale
measure: Slit Lamp Findings
time frame: 3 months
description: Grading by the Slit Lamp Classification Scale
arm group label: Test Group myopia control
arm group type: Experimental
description: Subjects wearing contact lenses made of LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for myopia control
arm group label: Myopia Control
arm group type: Active Comparator
description: Subjects wearing Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens for myopia control
intervention type: Device
intervention name: Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens
description: Daily Wear
arm group label: Test Group myopia control
intervention type: Device
intervention name: Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens
arm group label: Myopia Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: John M Szabocsik, PhD
role: Study Director
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Myopia