<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/NCT02249689</url>
  </required_header>
  <id_info>
    <org_study_id>CM-001-001</org_study_id>
    <nct_id>NCT02249689</nct_id>
  </id_info>
  <brief_title>Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses</brief_title>
  <official_title>Three-month Clinical Evaluation of Silicone Hydrogel Definitive 65 Contact Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Contamac Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hartwig Research Center</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Contamac Ltd</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>
      Comparison of different contact lens materials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a 3-month, open-label, bilateral, parallel-group, randomised, daily wear study.&#xD;
      Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear&#xD;
      the Control lenses in both eyes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>questionnaire addressing subjective comfort and wear time</measure>
    <time_frame>subjects will be followed-up for three months</time_frame>
    <description>Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>limbal redness - ocular biomicroscopy</measure>
    <time_frame>subjects will be followed-up for three months</time_frame>
    <description>Findings were graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>corneal staining - ocular biomicroscopy</measure>
    <time_frame>subjects will be followed-up for three months</time_frame>
    <description>Findings were graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Ametropia</condition>
  <arm_group>
    <arm_group_label>Definitive 65</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Test product were the Definitive 65 (Filcon V4) lenses. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Definitive 74</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Control product was the commercially available Definitive 74 (Efrofilcon A) lens. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Definitive 65</intervention_name>
    <arm_group_label>Definitive 65</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Definitive 74</intervention_name>
    <arm_group_label>Definitive 74</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  willing and able to sign the informed consent form&#xD;
&#xD;
          -  ages 18 years or older&#xD;
&#xD;
          -  Subjects must have owned spectacles or contact lenses prior to enrolment for this&#xD;
             trial&#xD;
&#xD;
          -  spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)&#xD;
&#xD;
          -  astigmatic power equal to or less than 0.75 D&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  eye injury or surgery within 3 months immediately prior to enrolment for this trial&#xD;
&#xD;
          -  pre-existing ocular irritation that would preclude contact lens fitting&#xD;
&#xD;
          -  currently enrolled in an ophthalmic clinical trial&#xD;
&#xD;
          -  evidence of systemic or ocular abnormality, infection or disease which is likely to&#xD;
             affect successful wear of contact lenses use of as determined by the investigator&#xD;
&#xD;
          -  any use of medications for which contact lens wear could be contradicted, as&#xD;
             determined by the investigator&#xD;
&#xD;
          -  current extended-wear users (sleep-in overnight)&#xD;
&#xD;
          -  current monovision leans wearers&#xD;
&#xD;
          -  pregnant women and nursing mothers&#xD;
&#xD;
          -  best-corrected visual acuity worse than 6/9 (logMAR: +0.20; Snellen decimal: 0.63)&#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>Andreas Hartwig, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hartwig Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siehste</name>
      <address>
        <city>Kassel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kresinsky</name>
      <address>
        <city>Würzburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</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>Refractive Errors</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/NCT02249689
org study id: CM-001-001
nct id: NCT02249689
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison of different contact lens materials.
This will be a 3-month, open-label, bilateral, parallel-group, randomised, daily wear study.
      Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear
      the Control lenses in both eyes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: questionnaire addressing subjective comfort and wear time
time frame: subjects will be followed-up for three months
description: Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.
measure: limbal redness - ocular biomicroscopy
time frame: subjects will be followed-up for three months
description: Findings were graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.
measure: corneal staining - ocular biomicroscopy
time frame: subjects will be followed-up for three months
description: Findings were graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.
arm group label: Definitive 65
arm group type: Experimental
description: The Test product were the Definitive 65 (Filcon V4) lenses. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.
arm group label: Definitive 74
arm group type: Active Comparator
description: The Control product was the commercially available Definitive 74 (Efrofilcon A) lens. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.
intervention type: Other
intervention name: Definitive 65
arm group label: Definitive 65
intervention type: Other
intervention name: Definitive 74
arm group label: Definitive 74
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andreas Hartwig, PhD
role: Principal Investigator
affiliation: Hartwig Research Center
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Refractive Errors