<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/NCT01665612</url>
  </required_header>
  <id_info>
    <org_study_id>FI-2012</org_study_id>
    <nct_id>NCT01665612</nct_id>
  </id_info>
  <brief_title>The Clinical and Subjective Performance of Three Different MPDS With Silicon Hydrogel Lenses</brief_title>
  <official_title>The Evaluation of the Clinical and Subjective Performance of Three Different Contact Lens Care Solutions With Silicon Hydrogel Lenses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Finnsusp Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Finnsusp Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the clinical investigation is to assess the clinical and subjective&#xD;
      performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two&#xD;
      silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Actual">January 2015</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>Crossover Assignment</intervention_model>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical performance</measure>
    <time_frame>1 month</time_frame>
    <description>TBUT, conjunctival and limbal hyperemia, corneal vascularization, epithelial and stromal oedema, corneal infiltrates, endothelial regularity, corneal staining and papillar conjunctivitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective performance</measure>
    <time_frame>1 month</time_frame>
    <description>E.g. Comfort</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Adverse Reaction to Contact Lens Solution</condition>
  <arm_group>
    <arm_group_label>MPDS1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Contact lens care solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MPDS2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Contact lens care solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MPDS3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Contact lens care solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Contact lens care solution</intervention_name>
    <description>Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses</description>
    <arm_group_label>MPDS1</arm_group_label>
    <arm_group_label>MPDS2</arm_group_label>
    <arm_group_label>MPDS3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age above 18&#xD;
&#xD;
          -  experienced contact lens user&#xD;
&#xD;
          -  good health (self-reported)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  eye disease or eye operations&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  medication that can affect sight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Riikka Järvinen, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Turku, Finland; Finnsusp Ltd, Finland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanna Vaahtoranta-Lehtonen, Dr. Ophth.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Turku University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Raision Näkökulma</name>
      <address>
        <city>Raisio</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>March 5, 2015</last_update_submitted>
  <last_update_submitted_qc>March 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Contact lens</keyword>
  <keyword>Care solution</keyword>
  <keyword>MPDS</keyword>
  <keyword>comfort</keyword>
  <!-- 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/NCT01665612
org study id: FI-2012
nct id: NCT01665612
lead sponsor: 
has dmc: Yes
The purpose of the clinical investigation is to assess the clinical and subjective
      performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two
      silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).
allocation: Randomized
intervention model: Crossover Assignment
masking: Triple (Participant, Care Provider, Investigator)
measure: Clinical performance
time frame: 1 month
description: TBUT, conjunctival and limbal hyperemia, corneal vascularization, epithelial and stromal oedema, corneal infiltrates, endothelial regularity, corneal staining and papillar conjunctivitis
measure: Subjective performance
time frame: 1 month
description: E.g. Comfort
arm group label: MPDS1
arm group type: Experimental
description: Contact lens care solution
arm group label: MPDS2
arm group type: Active Comparator
description: Contact lens care solution
arm group label: MPDS3
arm group type: Active Comparator
description: Contact lens care solution
intervention type: Device
intervention name: Contact lens care solution
description: Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses
arm group label: MPDS1
arm group label: MPDS2
arm group label: MPDS3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Riikka Järvinen, PhD
role: Study Director
affiliation: University of Turku, Finland; Finnsusp Ltd, Finland
last name: Hanna Vaahtoranta-Lehtonen, Dr. Ophth.
role: Principal Investigator
affiliation: Turku University Hospital
facility: 
country: Finland
responsible party type: Sponsor