None listed
Conditions
Brief summary
Manuka honey has a positive effect on enhancing the body’s natural immune responses due to its anti-inflammatory and antioxidant properties. Its antibacterial property is useful for wound healing and the prevention of inflammation. Other than the antibacterial property, manuka honey also showed to have antioxidant and anti-cancer properties. Multiple clinical trials have concluded its effectiveness against various ocular conditions: blepharitis, contact lens related dry eyes, and Meibomian Gland Dysfunction. The Optimel Manuka+ Dry Eye Drops packaging claimed: “For use as an adjunctive therapy in addition to good eyelid hygiene”.("Optimel Manuka+ Dry Eye Drops", 2020) However, the effectiveness of the Optimel Manuka+ Dry Eye Drops with the addition of eyelid hygiene therapies has not previously been investigated. Therefore, it is worthwhile to conduct a thorough investigation on this potential adjunctive treatment by measuring both the subjective and objective parameters associated with dry eye disease. Thus, this study will be a randomized clinical trial comparing the effectiveness of conventional adjunctive treatment (warm compresses) in combination with Optimel Manuka+ Dry Eye Drops on dry eye disease compared to the eye drops alone. This study will include at least 40 participants who experience dry eye, where they are randomly assigned into two groups receiving the combination therapy of warm compresses plus Optimel Manuka+ Dry Eye Drops or Optimel Manuka+ Dry Eye Drops only, where eye drops will be applied two times daily (Albietz & Schmid, 2017) in both eyes for one month. Optimel Manuka+ Dry Eye Drops are commercially available in Australia, therefore the results of this study will provide an evidenced based dry eye therapy option for society to consider.
Interventions
Optimel Antibacterial Manuka + Eye Drops 10mL (ARTG ID: 199785) contains standardised 16% antibacterial Manuka honey developed from Leptospermum sp, sodium chloride, and benzoic acid. It is available on the Australian market without prescription required.
ARTG Public Summary documentation:
https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=199785&agid=(PrintDetailsPublic)&actionid=1
The Bruder Moist Heat Eye Compress are warm compresses that are commonly used
Optimel Antibacterial Manuka + Eye Drops 10mL (ARTG ID: 199785) contains standardised 16% antibacterial Manuka honey developed from Leptospermum sp, sodium chloride, and benzoic acid. It is available on the Australian market without prescription required. ARTG Public Summary documentation: https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=199785&agid=(PrintDetailsPublic)&actionid=1 The Bruder Moist Heat Eye Compress are warm compresses that are commonly used as an easy way to treat chronic dry eye, MGD and Blepharitis. The compresses are applied over closed eyes for 10 minutes after heating it for 20 seconds in the microwave. ARTG Public Summary documentation: https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=223316&agid=(PrintDetailsPublic)&actionid=1 All products to be used for this study will follow all the conditions as set out in the ARTG public summary documentation. Participants allocated to the intervention group will administer both the eye drops and the warm compress twice daily for approximately 4 weeks. Participants will be instructed to apply the Bruder Moist Heat Eye Compresses for 10 minutes and then instil 1 drop of the Optimel Manuka+ Dry Eye Drops to each eye after an interval of 5 minutes. Participants will be asked to return for final evaluation and study exit (Visit 2) after approximately 4 weeks of daily use. Compliance: Compliance will be monitored by measuring and recording the weight of about 10 eye drop bottles to obtain an average weight prior to giving it to the participant, and at the beginning of visit 2. Warm compresses will be checked for compliance by directly asking the participants at Visit 2, and the unmasked investigator will schedule a phone call reminder 2 weeks after the first visit to both groups to check compliance with their treatments.
Sponsors
UNSW Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent; • General population aged 18 years and over; • In good general health; • Subjectively experiencing dry eye symptoms (e.g. burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun). Participants will be selected based on a minimum OSDI score of 13 points. • Have not used Optimel Manuka+ Dry Eye Drops in the past 3 months • Have not used warm compresses or lid scrubs in the past 1 month • Participant is willing to discontinue their current use of any rewetting/lubricating drops 3 days before the study and throughout the study; • Willing to comply with the dosage and study visit schedule as directed by the investigator; • Willing to notify the study investigator if instructed to alter their dietary intake of fish or omega-3 supplements by health/medical practitioner;
Exclusion criteria
• Allergy to benzoic acid preservatives; • Allergy to honey products; • Active anterior eye disease/ infection, inflammation/allergy that requires ocular medical treatment; • Eye injury or surgery in the past 6 months including chemical burns, penetrating injuries, traumatic iritis, orbital fractures, laser surgery, strabismus surgery, cataract or any other intraocular surgeries; • Soft contact lens wearer within one week prior to the study and during the study. • Rigid gas permeable, orthokeratology lens wear within 1 month prior to the study and during the study. • Current typical dietary intake of fish or oral supplements known to have anti-inflammatory properties; • Use of any of the following medications (including steroids) up to 12 weeks prior to start of the study or during the course of the study: o Ocular medication, category S3 and above; o Any systemic or topical medications that will affect ocular physiology e.g. anti-acne medications such as Roaccutane and corticosteroid or immunosuppressant medications such as Hydrocortisone, Prednisolone and antihistamine medications such as Claritine; • Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus; • Epilepsy or history of migraines exacerbated by flashing, strobe-like lights; • The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests.
Outcome results
None listed