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Trial registered on ANZCTR


Registration number
ACTRN12616000540415
Ethics application status
Approved
Date submitted
2/02/2016
Date registered
27/04/2016
Date last updated
27/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety of Manuka honey CycloPower ophthalmic cream
Scientific title
Effect of Manuka honey CycloPower ophthalmic micro-emulsion cream on ocular parameters in healthy participants compared with no treatment
Secondary ID [1] 288466 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blepharitis 297499 0
Condition category
Condition code
Eye 297689 297689 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention involves external application of Manuka honey CycloPower ophthalmic cream (0.5-1ml) to the skin of the upper and lower eyelids of one eye only (randomised to the right or left eye), once daily for 2 weeks. The fellow (untreated) eye serves as the control. Compliance is monitored through follow-up telephone calls and the weighing of returned unused cream.
Intervention code [1] 293800 0
Treatment: Other
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 297227 0
Skin hyperaemia as measured by VAS grading by the researcher
Timepoint [1] 297227 0
Day 7 and Day 14 after treatment commencement
Secondary outcome [1] 320408 0
Dry eye signs as measured by keratography
Timepoint [1] 320408 0
Day 7 and Day 14 after treatment commencement

Eligibility
Key inclusion criteria
1. Male or female healthy subjects aged 18-45 and in good health as determined by past medical history, physical examination, vital signs at screening.
2. Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study and understand and sign the written informed consent.
3. Be willing not to wear contact lenses for 2 days prior to the start of the study and for the duration of the study
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known allergy to any components of the microemulsion (bee products or Manuka honey Cyclopower)
2. Pregnancy or planned pregnancy during the course of the study
3. A past medical history or evidence of significant dermatological conditions e.g. eczema, dermatitis
4. A past medical history or evidence of ophthalmic disease that could affect study outcomes
5. A past history or evidence of systemic disease that could affect the study outcomes
6. Dosing of a study drug in any clinical investigation within 30 days prior to initial treatment in this study.

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)
Treated eye and control eye allocation will be randomised and concealed from the investigator via opaque sealed envelopes given to the subjects.
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 study
Phase
Not Applicable
Type of endpoint(s)
Safety
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] 7567 0
New Zealand
State/province [1] 7567 0
Auckland

Funding & Sponsors
Funding source category [1] 292810 0
Commercial sector/Industry
Name [1] 292810 0
Manuka Health New Zealand Ltd
Address [1] 292810 0
34 Hannigan Dr, St Johns, Auckland 1072
Country [1] 292810 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
85 Park Road, Grafton, Auckland, 1023
Country
New Zealand
Secondary sponsor category [1] 291549 0
Commercial sector/Industry
Name [1] 291549 0
Manuka Health New Zealand Ltd.
Address [1] 291549 0
34 Hannigan Dr, St Johns, Auckland 1072
Country [1] 291549 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294311 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 294311 0
Private Bag 92019
Auckland 1142
Ethics committee country [1] 294311 0
New Zealand
Date submitted for ethics approval [1] 294311 0
08/09/2014
Approval date [1] 294311 0
03/12/2014
Ethics approval number [1] 294311 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 reducing the bacterial load, and the level of inflammation in 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, and then in vivo in an animal study. Thus, we hypothesise that the use of Manuka Honey with CycloPower may be safe and well tolerated in healthy human volunteers in this present trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63254 0
A/Prof Jennifer P Craig
Address 63254 0
Department of Ophthalmology
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country 63254 0
New Zealand
Phone 63254 0
+6499238173
Fax 63254 0
+6493677173
Email 63254 0
jp.craig@auckland.ac.nz
Contact person for public queries
Name 63255 0
A/Prof Jennifer P Craig
Address 63255 0
Department of Ophthalmology
Faculty of Medical and Health Sciences
The University of Auckland
85 Park Rd, Grafton
Auckland 1142
Country 63255 0
New Zealand
Phone 63255 0
+6499238173
Fax 63255 0
+6493677173
Email 63255 0
jp.craig@auckland.ac.nz
Contact person for scientific queries
Name 63256 0
A/Prof Jennifer P Craig
Address 63256 0
Department of Ophthalmology
Faculty of Medical and Health Sciences
The University of Auckland
85 Park Rd, Grafton
Auckland 1142
Country 63256 0
New Zealand
Phone 63256 0
+6499238173
Fax 63256 0
+6493677173
Email 63256 0
jp.craig@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary