None listed
Conditions
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.
Interventions
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.
Sponsors
The University of Auckland
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 No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed