xml: <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/NCT05990712</url>
    </required_header>
    <id_info>
      <org_study_id>UptownEye4</org_study_id>
      <nct_id>NCT05990712</nct_id>
    </id_info>
    <brief_title>The Effect of a Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers</brief_title>
    <official_title>A Prospective Study on the Effect of Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers Between Two Ocular Hygiene Regimen Groups</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uptown Eye Specialists</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>WIlliam Osler Health Systems</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Forsee Canada</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Uptown Eye Specialists</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study assesses the impact of two differing ocular hygiene regimens prior to cataract&#xD;
        surgery. The first regimen includes an omega-3 supplement and the second without, and both&#xD;
        include an at-home lid wipe and cleansing eye drops. These regimens will be assessed on&#xD;
        microbial load, inflammation, tear osmolarity, and dry eye metrics. Patients will be&#xD;
        randomized to either the omega-3 group + 3-part hygiene regimen, or the group with only the&#xD;
        3-part hygiene regimen. Data will be collected for inflammation through a test (InflammaDry)&#xD;
        that measures an inflammatory marker, dry eye metrics via an imaging tool called Oculus 5M&#xD;
        and the Canadian Dry Eye Assessment (CDEA) questionnaire, tear osmolarity through Tear Labs&#xD;
        device, and area of growth for conjunctiva microbial load by swabbing the conjunctiva of the&#xD;
        eye. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline&#xD;
        appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load swabs will&#xD;
        be collected at baseline, 2-5 days prior to surgery, and date of the surgery. An ocular&#xD;
        assessment will also be completed at baseline, one week post-operation, and one month&#xD;
        post-operation. All metrics will be compared to the fellow eye. The usage of omega-3 will be&#xD;
        compared to the regimen without omega-3.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Prospective interventional study assessing the impact of two ocular hygiene regimens, with&#xD;
        and without Omega-3, on microbial load, inflammation, tear osmolarity, and dry eye metrics&#xD;
        and disease for patients soon to undergo cataract surgery. Study recruitment will occur at&#xD;
        Uptown Eye between Sept-Nov 2023, with a target of 68 patients enrolled in the study.&#xD;
        Patients will be consecutively randomized to group 1 (without omega 3 group) or group 2 (with&#xD;
        omega 3 group). The intervention includes Zocular in clinic at baseline, Thealoz Duo eyedrops&#xD;
        twice daily until surgery, and the cleansing wipes twice daily until surgery. The omega 3&#xD;
        group will take the supplement from baseline until one month post-operative.&#xD;
  &#xD;
        Data will be collected for inflammation through a InflammaDry Matrix metallopeptidase 9&#xD;
        (MMP-9) test, dry eye through Oculus 5M (measures non-invasive break-up time (NIBUT), lipid&#xD;
        layer, bulbar redness, tear meniscus height) and Canadian Dry Eye Assessment (CDEA), TearLab&#xD;
        for osmolarity, and conjunctival swabs for microbial load. Dry eye metrics (CDEA and Oculus&#xD;
        5M) will be collected during the patient's baseline Cataract Dry Eye Clinic (CDEC)&#xD;
        appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load will be&#xD;
        collected at baseline, 2-5 days prior to surgery, and date of the surgery. Tear osmolarity&#xD;
        and inflammation markers will be collected at baseline, 2-5 days prior to surgery, and&#xD;
        post-operative month. An ocular assessment will also be completed at baseline, one week&#xD;
        post-operation, and post-operative month. All metrics will be compared to the fellow eye.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>Phase 4</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>
      <intervention_model_description>Patients will be assigned to either the omega-3 group or no omega-3 group.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>MMP-9</measure>
      <time_frame>Baseline, 2-5 days prior to surgery, post-operative month 1</time_frame>
      <description>Level of MMP-9, an inflammatory marker reported as positive (level of MMP-9 &gt; 40ng/mL) or negative (level of MMP-9 &lt; 40ng/mL).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Microbial load</measure>
      <time_frame>Baseline, 2-5 days prior to surgery, surgery day</time_frame>
      <description>Area of microbial growth from conjunctival swab reported as percentage of dish coverage, incubated for 48 hours</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tear osmolarity</measure>
      <time_frame>Baseline, 2-5 days prior to surgery, surgery day</time_frame>
      <description>Measure of salt concentration in tear reported as mOsm/L</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Non-invasive break-up time (NIBUT)</measure>
      <time_frame>Baseline, 2-5 days prior to surgery, post-operative month 1</time_frame>
      <description>Non-invasive break-up time (NIBUT) is measured using the Oculus 5M and measured in seconds, with longer NIBUT representing better outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lipid layer</measure>
      <time_frame>Baseline, 2-5 days prior to surgery, post-operative month 1</time_frame>
      <description>Lipid layer is reported in nanometres with higher/thicker lipid layers representing a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bulbar redness</measure>
      <time_frame>Baseline, 2-5 days prior to surgery, post-operative month 1</time_frame>
      <description>Bulbar redness is reported by a score from 0-4 with lower scores representing a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tear meniscus height</measure>
      <time_frame>Baseline, 2-5 days prior to surgery, post-operative month 1</time_frame>
      <description>Tear meniscus height (TMH) is reported in millimetres, with increases in TMH representing a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Canadian Dry Eye Assessment (CDEA) Questionnaire</measure>
      <time_frame>Baseline, 2-5 days prior to surgery, post-operative month 1</time_frame>
      <description>12 item questionnaire for reporting of dry eye symptoms on a scale of 0-4. Total scores for the CDEA questionnaire range from 0 to 48 and are interpreted as no dry eye symptoms or normal (&lt;5), mild dry eye symptoms (5-20), moderate dry eye symptoms (21-30), or severe dry eye symptoms (31-48).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">68</enrollment>
    <condition>Dry Eye</condition>
    <condition>Dry Eye Syndromes</condition>
    <condition>Cataract</condition>
    <arm_group>
      <arm_group_label>Omega-3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this arm will take oral omega-3 supplement for 4 weeks pre-operatively and 4 weeks post-operatively. They will also receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Omega-3</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in this arm will not take oral omega-3 supplement. They will only receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Omega-3</intervention_name>
      <description>Omega-3 is a fatty acid and there is evidence that the consumption of re-esterified oral omega-3 supplements over the course of 6 to 8 weeks aid in reducing inflammation, dry eye, and optimizing tear osmolarity. The oral omega-3 supplement taken daily.</description>
      <arm_group_label>Omega-3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Trehalose</intervention_name>
      <description>Eyedrops consisting of trehalose and sodium hyaluronate that lubricate and hydrate the eye to relieve dry eye.</description>
      <arm_group_label>No Omega-3</arm_group_label>
      <arm_group_label>Omega-3</arm_group_label>
      <other_name>Thealoz Duo Drops</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Zocular Eyelid System Treatment</intervention_name>
      <description>A lid cleaning and debridement system that consists of okra-based gel to relieve dry eye or inflammation. The gel is applied to the eyelid margin and lashes with a cotton swab.</description>
      <arm_group_label>No Omega-3</arm_group_label>
      <arm_group_label>Omega-3</arm_group_label>
      <other_name>ZEST</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blephadex cleansing eyelid wipes</intervention_name>
      <description>Eyelid cleansing wipes with tea tree oil and coconut that help reduce infection.</description>
      <arm_group_label>No Omega-3</arm_group_label>
      <arm_group_label>Omega-3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients 18 or older who underwent cataract surgical ocular hygiene treatment regimen&#xD;
               prior to cataract surgery.&#xD;
  &#xD;
            -  Patients of all severity of dry eye will be included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with any other ocular comorbidities (glaucoma, iritis, traumatic eye injury,&#xD;
               known systemic autoimmune diseases, immune disorders, anti-inflammatory medications,&#xD;
               blood disorders (eg. altered white counts), prior surgery, prior traumatic eye injury,&#xD;
               previous dry eye interventions such as ocular plugs, radiofrequency, and IPL).&#xD;
  &#xD;
            -  Patients who have any complications arise during the cataract surgery.&#xD;
  &#xD;
            -  Patients with altered mental state and cannot provide informed consent.&#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_contact>
      <last_name>Sohel Somani, MD</last_name>
      <phone>416-292-0330</phone>
      <email>sohel.somani@uptowneye.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Uptown Eye</name>
        <address>
          <city>Brampton</city>
          <state>Ontario</state>
          <zip>L6Y 0P6</zip>
          <country>Canada</country>
        </address>
      </facility>
      <contact>
        <last_name>Sohel Somani, MD</last_name>
        <email>sohel.somani@uptowneye.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pre-operative</keyword>
    <keyword>Ocular hygiene</keyword>
    <keyword>Omega 3</keyword>
    <keyword>Microbial load</keyword>
    <keyword>Inflammation</keyword>
    <keyword>Tear osmolarity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cataract</mesh_term>
      <mesh_term>Dry Eye Syndromes</mesh_term>
      <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990712
  org study id: UptownEye4
  nct id: NCT05990712
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  This study assesses the impact of two differing ocular hygiene regimens prior to cataract
        surgery. The first regimen includes an omega-3 supplement and the second without, and both
        include an at-home lid wipe and cleansing eye drops. These regimens will be assessed on
        microbial load, inflammation, tear osmolarity, and dry eye metrics. Patients will be
        randomized to either the omega-3 group + 3-part hygiene regimen, or the group with only the
        3-part hygiene regimen. Data will be collected for inflammation through a test (InflammaDry)
        that measures an inflammatory marker, dry eye metrics via an imaging tool called Oculus 5M
        and the Canadian Dry Eye Assessment (CDEA) questionnaire, tear osmolarity through Tear Labs
        device, and area of growth for conjunctiva microbial load by swabbing the conjunctiva of the
        eye. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline
        appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load swabs will
        be collected at baseline, 2-5 days prior to surgery, and date of the surgery. An ocular
        assessment will also be completed at baseline, one week post-operation, and one month
        post-operation. All metrics will be compared to the fellow eye. The usage of omega-3 will be
        compared to the regimen without omega-3.
  Prospective interventional study assessing the impact of two ocular hygiene regimens, with
        and without Omega-3, on microbial load, inflammation, tear osmolarity, and dry eye metrics
        and disease for patients soon to undergo cataract surgery. Study recruitment will occur at
        Uptown Eye between Sept-Nov 2023, with a target of 68 patients enrolled in the study.
        Patients will be consecutively randomized to group 1 (without omega 3 group) or group 2 (with
        omega 3 group). The intervention includes Zocular in clinic at baseline, Thealoz Duo eyedrops
        twice daily until surgery, and the cleansing wipes twice daily until surgery. The omega 3
        group will take the supplement from baseline until one month post-operative.
  
        Data will be collected for inflammation through a InflammaDry Matrix metallopeptidase 9
        (MMP-9) test, dry eye through Oculus 5M (measures non-invasive break-up time (NIBUT), lipid
        layer, bulbar redness, tear meniscus height) and Canadian Dry Eye Assessment (CDEA), TearLab
        for osmolarity, and conjunctival swabs for microbial load. Dry eye metrics (CDEA and Oculus
        5M) will be collected during the patient's baseline Cataract Dry Eye Clinic (CDEC)
        appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load will be
        collected at baseline, 2-5 days prior to surgery, and date of the surgery. Tear osmolarity
        and inflammation markers will be collected at baseline, 2-5 days prior to surgery, and
        post-operative month. An ocular assessment will also be completed at baseline, one week
        post-operation, and post-operative month. All metrics will be compared to the fellow eye.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be assigned to either the omega-3 group or no omega-3 group.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: MMP-9
  time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
  description: Level of MMP-9, an inflammatory marker reported as positive (level of MMP-9 > 40ng/mL) or negative (level of MMP-9 < 40ng/mL).
  measure: Microbial load
  time frame: Baseline, 2-5 days prior to surgery, surgery day
  description: Area of microbial growth from conjunctival swab reported as percentage of dish coverage, incubated for 48 hours
  measure: Tear osmolarity
  time frame: Baseline, 2-5 days prior to surgery, surgery day
  description: Measure of salt concentration in tear reported as mOsm/L
  measure: Non-invasive break-up time (NIBUT)
  time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
  description: Non-invasive break-up time (NIBUT) is measured using the Oculus 5M and measured in seconds, with longer NIBUT representing better outcomes.
  measure: Lipid layer
  time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
  description: Lipid layer is reported in nanometres with higher/thicker lipid layers representing a better outcome.
  measure: Bulbar redness
  time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
  description: Bulbar redness is reported by a score from 0-4 with lower scores representing a better outcome.
  measure: Tear meniscus height
  time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
  description: Tear meniscus height (TMH) is reported in millimetres, with increases in TMH representing a better outcome.
  measure: Canadian Dry Eye Assessment (CDEA) Questionnaire
  time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
  description: 12 item questionnaire for reporting of dry eye symptoms on a scale of 0-4. Total scores for the CDEA questionnaire range from 0 to 48 and are interpreted as no dry eye symptoms or normal (<5), mild dry eye symptoms (5-20), moderate dry eye symptoms (21-30), or severe dry eye symptoms (31-48).
  arm group label: Omega-3
  arm group type: Experimental
  description: Participants in this arm will take oral omega-3 supplement for 4 weeks pre-operatively and 4 weeks post-operatively. They will also receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.
  arm group label: No Omega-3
  arm group type: Active Comparator
  description: Participants in this arm will not take oral omega-3 supplement. They will only receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.
  intervention type: Dietary Supplement
  intervention name: Omega-3
  description: Omega-3 is a fatty acid and there is evidence that the consumption of re-esterified oral omega-3 supplements over the course of 6 to 8 weeks aid in reducing inflammation, dry eye, and optimizing tear osmolarity. The oral omega-3 supplement taken daily.
  arm group label: Omega-3
  intervention type: Drug
  intervention name: Trehalose
  description: Eyedrops consisting of trehalose and sodium hyaluronate that lubricate and hydrate the eye to relieve dry eye.
  arm group label: No Omega-3
  arm group label: Omega-3
  other name: Thealoz Duo Drops
  intervention type: Drug
  intervention name: Zocular Eyelid System Treatment
  description: A lid cleaning and debridement system that consists of okra-based gel to relieve dry eye or inflammation. The gel is applied to the eyelid margin and lashes with a cotton swab.
  arm group label: No Omega-3
  arm group label: Omega-3
  other name: ZEST
  intervention type: Other
  intervention name: Blephadex cleansing eyelid wipes
  description: Eyelid cleansing wipes with tea tree oil and coconut that help reduce infection.
  arm group label: No Omega-3
  arm group label: Omega-3
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sohel Somani, MD
  phone: 416-292-0330
  email: sohel.somani@uptowneye.ca
  facility: 
  contact: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Cataract
  mesh term: Dry Eye Syndromes
  mesh term: Keratoconjunctivitis Sicca
  sharing ipd: No