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Safety of Manuka honey CycloPower ophthalmic cream

Effect of Manuka honey CycloPower ophthalmic micro-emulsion cream on ocular parameters in healthy participants compared with no treatment

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000540415
Enrollment
25
Registered
2016-04-27
Start date
2014-12-08
Completion date
2015-04-24
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

The University of Auckland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 26, 2026