<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/NCT04457648</url>
  </required_header>
  <id_info>
    <org_study_id>MGD1</org_study_id>
    <nct_id>NCT04457648</nct_id>
  </id_info>
  <brief_title>Manuka Honey Eye Drops VS Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease</brief_title>
  <official_title>Randomized Assessor Masked Trial Comparing Manuka Honey Eye Drops to Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      Assessor-masked (Single blind, randomized controlled trial comparing the conventional&#xD;
      treatment group to an interventional group using 16% Manuka Honey topical eye drops.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose To evaluate the effects of conventional treatment compared to use of Manuka Honey eye&#xD;
      drops in the treatment of meibomian gland dysfunction related dry eye disease.&#xD;
&#xD;
      Design Assessor-masked (Single blind, randomized controlled trial comparing the conventional&#xD;
      treatment group to an interventional group using 16% Manuka Honey topical eye drops.&#xD;
&#xD;
      Methods Patients were randomized into two groups, one group given conventional treatment for&#xD;
      meibomian gland dysfunction. The other group was given additional manuka honey 16% eye drops&#xD;
      which are registered as a medical device by the australian FDA. SPEED score was taken at&#xD;
      baseline and upon follow up. Multiple parameters were graded from slit lamp examination by a&#xD;
      masked assessor. Results were compared from baseline to follow up date 3 weeks later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>speed score</measure>
    <time_frame>3 weeks</time_frame>
    <description>questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Meibomian Gland Dysfunction</condition>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Manuka Honey</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>manuka honey 16% eye drops ( Optimel )</intervention_name>
    <description>16% manuka honey eye drops, australian FDA approved</description>
    <arm_group_label>Manuka Honey</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>systane eye drops</intervention_name>
    <description>systane lubricant eye drops</description>
    <arm_group_label>Conventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  meibomian gland dysfunction stage 2-4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years old Unable to consent Recent ophthalmic surgery &lt;6m Abnormalities of lid&#xD;
             position Allergy to honey/bee products Contact lens wearers Patients on long term&#xD;
             topical medications apart from lubricants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>chinese university of Hong kong</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Anita Li</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
    <mesh_term>Meibomian Gland Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>protocol</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>6 months after completion for 6 months</ipd_time_frame>
  </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/NCT04457648
org study id: MGD1
nct id: NCT04457648
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assessor-masked (Single blind, randomized controlled trial comparing the conventional
      treatment group to an interventional group using 16% Manuka Honey topical eye drops.
Purpose To evaluate the effects of conventional treatment compared to use of Manuka Honey eye
      drops in the treatment of meibomian gland dysfunction related dry eye disease.

      Design Assessor-masked (Single blind, randomized controlled trial comparing the conventional
      treatment group to an interventional group using 16% Manuka Honey topical eye drops.

      Methods Patients were randomized into two groups, one group given conventional treatment for
      meibomian gland dysfunction. The other group was given additional manuka honey 16% eye drops
      which are registered as a medical device by the australian FDA. SPEED score was taken at
      baseline and upon follow up. Multiple parameters were graded from slit lamp examination by a
      masked assessor. Results were compared from baseline to follow up date 3 weeks later.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: speed score
time frame: 3 weeks
description: questionnaire
arm group label: Conventional
arm group type: Placebo Comparator
arm group label: Manuka Honey
arm group type: Active Comparator
intervention type: Device
intervention name: manuka honey 16% eye drops ( Optimel )
description: 16% manuka honey eye drops, australian FDA approved
arm group label: Manuka Honey
intervention type: Device
intervention name: systane eye drops
description: systane lubricant eye drops
arm group label: Conventional
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Anita Li
investigator title: Principal Investigator
mesh term: Dry Eye Syndromes
mesh term: Eye Diseases
mesh term: Meibomian Gland Dysfunction
mesh term: Ophthalmic Solutions
sharing ipd: Yes
ipd description: protocol
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 6 months after completion for 6 months