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Trial registered on ANZCTR


Registration number
ACTRN12616000539437
Ethics application status
Approved
Date submitted
2/02/2016
Date registered
27/04/2016
Date last updated
21/03/2019
Date data sharing statement initially provided
21/03/2019
Date results information initially provided
21/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Manuka honey CycloPower ophthalmic cream in managing blepharitis
Scientific title
Effect of Manuka honey CycloPower ophthalmic micro-emulsion cream on ocular parameters in blepharitis compared with no treatment
Secondary ID [1] 288467 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blepharitis 297500 0
Condition category
Condition code
Eye 297690 297690 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Manuka honey CycloPower ophthalmic cream (0.5-1ml) will be applied externally to the skin of the upper and lower eyelid of one eye only (randomised to left or right), once daily, for 12 weeks, while the fellow eye serves as the control. Compliance will be monitored through follow-up telephone calls and the weighing of returned unused cream.
Intervention code [1] 293801 0
Treatment: Other
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 297229 0
Dry eye signs as measured by keratography
Timepoint [1] 297229 0
Weeks 1, 4 and 12 after treatment commencement
Primary outcome [2] 298113 0
Dry eye symptoms by validated questionnaires; Standard Patient Evaluation of Eye Dryness (SPEED) and Symptom Assessment iN Dry Eye (SANDE)
Timepoint [2] 298113 0
Weeks 1, 4 and 12 after treatment commencement
Secondary outcome [1] 320409 0
Lid margin microbial load as measured by laboratory culture of lid margin swabs followed by enumeration of bacteria
Timepoint [1] 320409 0
Weeks 1, 4 and 12 after treatment commencement
Secondary outcome [2] 320410 0
Ocular surface inflammation as measured by laboratory analysis of gene expression of inflammatory marker molecules (MMP-9 and IL-6) in cytological impressions of the conjunctiva
Timepoint [2] 320410 0
Weeks 1, 4 and 12 after treatment commencement

Eligibility
Key inclusion criteria
- Males or females
- Age 18 years or over
- Normal lid / lash anatomy, and closure
- Clinically significant signs of blepharitis and symptoms of dry eye
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contact lens wearers unwilling to remove lenses 48 hours prior to commencement of, and for the duration of, the study.
- Ocular surgery (such as refractive or cataract surgery) in either eye within 3 months of the screening visit
- A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.)
- The history or presence of any significant skin condition or disorder that might interfere with the study outcomes.
- The history or presence of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or patient safety such as a significant reduction in visual acuity e.g. less than 20/200; significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection or inflammation unrelated to dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection, etc.
- Known hypersensitivity to any of the components of the study preparation or bee products
- Active or uncontrolled severe systemic allergy, chronic seasonal allergies, rhinitis or sinusitis requiring treatment (i.e. antihistamines, decongestants, oral or aerosol steroids) at the time of screening
- Use of medication known to cause ocular drying (e.g., cyclosporine, antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, diuretics, phenothiazines, steroids, etc.) within 30 days of the screening visit
- Punctal plugs (unless permanent)
- Participation in any clinical trial with a new active substance or a new device during the past 30
- Women who are pregnant, planning a pregnancy or nursing at study entry.

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)
Subject eligibility will be assessed and participants will be enrolled with informed consent if the inclusion and exclusion criteria are met. Treated eye and control eye allocation will be randomised and concealed from the investigator via opaque sealed envelopes given to the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation schedule allocates the left/right eye to treatment/control
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other
Other design features
Paired eye trial
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7568 0
New Zealand
State/province [1] 7568 0
Auckland

Funding & Sponsors
Funding source category [1] 292811 0
Commercial sector/Industry
Name [1] 292811 0
Manuka Health New Zealand Ltd
Address [1] 292811 0
66 Weona Court,
Te Awamutu 3800
Country [1] 292811 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Department of Ophthalmology
Faculty of Medical and Health Sciences
University of Auckland
85 Park Rd, Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 291552 0
Commercial sector/Industry
Name [1] 291552 0
Manuka Health New Zealand Ltd
Address [1] 291552 0
66 Weona Court,
Te Awamutu 3800
Country [1] 291552 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294313 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 294313 0
The University of Auckland
Private Bag 92019
Auckland 1142
Ethics committee country [1] 294313 0
New Zealand
Date submitted for ethics approval [1] 294313 0
31/10/2015
Approval date [1] 294313 0
05/11/2015
Ethics approval number [1] 294313 0
013084

Summary
Brief summary
Blepharitis, or inflammation of the eyelid, is a common, debilitating and chronic condition. This disease manifests clinically as either anterior blepharitis affecting the front portion of the eyelid and the eyelashes, or posterior blepharitis which involves the inner eyelid. Posterior blepharitis is usually caused by dysfunction of the lipid-producing meibomian glands in the eyelid and both types of blepharitis increase the susceptibility of the eyelids to over-colonisation by bacteria.

Existing treatments for eyelid disease are costly and ineffective, and no readily and commercially available ophthalmic product targets both the bacterial and inflammatory disease processes. Both the anti-bacterial and anti-inflammatory effects of New Zealand native Manuka honey have been proven, and it has been shown in research conducted in collaboration with Medihoney Antibacterial Honey (Medihoney Pty Ltd., Australia) that a honey-based ophthalmic formation may have a therapeutic effect in blepharitis and meibomian gland dysfunction (MGD). Therefore, there is a clear rationale for developing a novel ophthalmic product based on New Zealand native Manuka honey for the clinical treatment of blepharitis and MGD.

We identified the species of bacteria present on the eyelids of people affected by eyelid disease and demonstrated that Manuka Honey with CycloPower has an anti-bacterial effect on these specific microorganisms. Subsequently, we developed a formulation of Manuka Honey with CycloPower suitable for use externally around the eye and the safety and lack of toxicity of this product was demonstrated first in a corneal epithelial cell line in vitro, then in vivo in an animal study, and finally in healthy human volunteers. Thus, we hypothesise that Manuka Honey with CycloPower may improve the clinical signs and symptoms of blepharitis in this present trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63258 0
A/Prof Jennifer P Craig
Address 63258 0
Department of Ophthalmology
The University of Auckland
Private Bag 91019
Auckland 1142
Country 63258 0
New Zealand
Phone 63258 0
+6499238173
Fax 63258 0
+6493677173
Email 63258 0
jp.craig@auckland.ac.nz
Contact person for public queries
Name 63259 0
A/Prof Jennifer P Craig
Address 63259 0
Department of Ophthalmology
The University of Auckland
Private Bag 91019
Auckland 1142
Country 63259 0
New Zealand
Phone 63259 0
+6499238173
Fax 63259 0
+6493677173
Email 63259 0
jp.craig@auckland.ac.nz
Contact person for scientific queries
Name 63260 0
A/Prof Jennifer P Craig
Address 63260 0
Department of Ophthalmology
The University of Auckland
Private Bag 91019
Auckland 1142
Country 63260 0
New Zealand
Phone 63260 0
+6499238173
Fax 63260 0
+6493677173
Email 63260 0
jp.craig@auckland.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
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary