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Trial registered on ANZCTR


Registration number
ACTRN12617000144314p
Ethics application status
Not yet submitted
Date submitted
19/01/2017
Date registered
27/01/2017
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Sterilid or Honevo as a treatment for Blepharitis.
Scientific title
A Single Blind, Parallel Group, Randomised Controlled Trial of Sterilid vs Honevo for the treatment of Blepharitis in adult participants.
Secondary ID [1] 290967 0
Nil known
Universal Trial Number (UTN)
U1111-1188-3091
Trial acronym
KH11
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blepharitis 301711 0
Condition category
Condition code
Eye 301413 301413 0 0
Diseases / disorders of the eye
Alternative and Complementary Medicine 301428 301428 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Honevo, which is topical medical grade Kanuka honey (10% glycerine and 90% Kanuka honey) is liberally applied to the affected eyelid margins once per day at night for 60 seconds for a period of twenty eight days. A participant ediary will record applications every four days during this period.
Intervention code [1] 296921 0
Treatment: Other
Comparator / control treatment
Standard treatment is focused around lid hygiene. Participants in the control arm will liberally apply Sterilid (active ingredient is tea tree oil) once a day at night for 60 seconds for a period of twenty eight days. A participant ediary will record applications every four days during this period.
Control group
Active

Outcomes
Primary outcome [1] 300804 0
The primary outcome is the acceptability of Honevo for the treatment of Blepharitis as compared to standard Sterilid therapy. These are assessed using five-point Likert-like questionnaires and will be compared using ordinal regression.
Timepoint [1] 300804 0
Day twenty eight.
Secondary outcome [1] 330914 0
Feasibility of using an electronic enrollment and consent system in a community based randomized controlled trial.
This is being assessed generally based on feedback from the optician and how smoothly the trial runs.
Timepoint [1] 330914 0
Day twenty eight.
Secondary outcome [2] 330915 0
Change in visit 2 (day twenty eight) patient assessment score from baseline. The patient assessment score is designed for this study.
Timepoint [2] 330915 0
Day twenty eight.
Secondary outcome [3] 330916 0
Change in visit two Blepharitis severity score from baseline. The Blepharitis severity score was designed for this study.
Timepoint [3] 330916 0
Day twenty eight.

Eligibility
Key inclusion criteria
Equal to or greater than 16 years old at the time of enrolment.
Optometrist diagnosis of current chronic blepharitis.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Requirement of any topical or systemic antibiotic for any ophthalmic indication.
Requirement of any topical or systemic corticosteroid for any ophthalmic indication.
Use of any systemic corticosteroid or antibiotic for any indication during the 14 days prior to enrolment.
Known or suspected allergy to honey, bees, glycerine, Sterilid (Registered Trademark) or Tea tree oil.
Any condition or issue which, at the investigators discretion may pose a safety risk or impact the validity of the study results.
Ocular surgery within the last 3 months or planned during the following 3 months.
Pregnant or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised 1:1 to treatment with either: Sterilid or Honevo. The randomization list will consist of 30-sequential allocation codes, numbered 1 to 30, which will correspond to one of two treatment groups, of which there will be an equal number. A randomisation field coded within the system that relays a randomisation schedule generated by the study biostatistician, will randomise patients at the time of enrolment at the opticians via the tablet.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Biostatastitian to generate randomization schedule using simple randomization generated by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participant and study site staff will not be blinded to the allocated treatment due to the nature of the investigational product. Data analysis will be conducted by a statastitian blinded to the allocation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
30 participants comprising 15 in each treatment arm will be recruited. Simple descriptive statistics appropriate to a feasibility pilot study will be undertaken. This will include the proportional comparison of patient reported acceptability, degree of symptomatic and physical improvement between the treatment groups. Acceptability measured on a ten point scale will be compared with t-tests. The Patient Assessment Score (PAS) and Blepharitis Severity Score (BSS) are five level Likert-like questionnaires and will be compared by ordinal regression. In order to attempt to establish the MCID a Likert scale will be used for participants to rate their improvement and a range of optimal cut-points based on this scale and the PAS and BSS will be explored to determine an appropriate level to set for a likely minimum clinically important difference (MCID) for these instruments. The distribution of the response instruments will then be used to model a translation of this to an ordinal odds ratio reflecting the likelihood of a clinically important response.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Resources allocated elsewhere
Date of first participant enrolment
Anticipated
1/03/2017
Actual
Date of last participant enrolment
Anticipated
1/09/2017
Actual
Date of last data collection
Anticipated
29/09/2017
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 8596 0
New Zealand
State/province [1] 8596 0

Funding & Sponsors
Funding source category [1] 295383 0
Commercial sector/Industry
Name [1] 295383 0
Honeylab Ltd
Country [1] 295383 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Honeylab Ltd
Address
Honeylab Ltd
1 Queens Warf
Wellington
6011
Country
New Zealand
Secondary sponsor category [1] 294206 0
None
Name [1] 294206 0
None
Address [1] 294206 0
NA
Country [1] 294206 0
Other collaborator category [1] 279406 0
Charities/Societies/Foundations
Name [1] 279406 0
Medical Research Institute of New Zealand
Address [1] 279406 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country [1] 279406 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296720 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 296720 0
Ethics committee country [1] 296720 0
New Zealand
Date submitted for ethics approval [1] 296720 0
28/02/2017
Approval date [1] 296720 0
Ethics approval number [1] 296720 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71866 0
Dr Alex Semprini
Address 71866 0
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country 71866 0
New Zealand
Phone 71866 0
+64 4 8050147
Fax 71866 0
+64 4 3895707
Email 71866 0
alex.semprini@mrinz.ac.nz
Contact person for public queries
Name 71867 0
Alex Semprini
Address 71867 0
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country 71867 0
New Zealand
Phone 71867 0
+64 4 8050147
Fax 71867 0
+64 4 3895707
Email 71867 0
alex.semprini@mrinz.ac.nz
Contact person for scientific queries
Name 71868 0
Alex Semprini
Address 71868 0
Level 7, CSB Building
Wellington Hospital
Riddiford St, Newtown
Wellington 6021
Country 71868 0
New Zealand
Phone 71868 0
+64 4 8050147
Fax 71868 0
+64 4 3895707
Email 71868 0
alex.semprini@mrinz.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study cancelled


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.