None listed
Conditions
Brief summary
Dry eye disease is a chronic, multifactorial disorder characterised by instability or poor quality of the tear film. It is associated with a wide variety of signs and symptoms, such as discomfort or visual disturbances (Lemp & Noulks, 2007). Due to the constancy and potential severity of these symptoms, dry eye patients may have their quality of life severely impacted, particularly with activities requiring visual attention like reading, driving or computer work (Uchino et al., 2014). Prevalence of dry eye disease can range from 5–50% depending on the population, with prevalence increasing with age or chronic illnesses (Rouen & White, 2018). Management is targeted towards symptomatic relief and tear film homeostasis, whether by improving tear production or reducing tear evaporation. Previous studies have shown that the Bruder Moist Heat Eye Compress and Optimel Manuka+ Dry Eye Drops have been effective in managing dry eye disease. The former seeks to improve meibum secretions to stabilise the tear film (Tan et al, 2018), whereas the latter has both anti-inflammatory and antibacterial properties to alleviate symptoms of dry eye disease (Tan et al., 2020). However, conventional or standalone treatments may not be effective for everyone; as such, a combination of the Bruder mask and manuka honey eye drops may offer a novel approach to treating dry eye disease. The proposed research aims to assess the effectiveness of this combination and provide evidence for its potential use in clinical practice. It will use both subjective and objective metrics to evaluate changes in tear film properties, eyelid health and comfort, thereby providing valuable information on the potential benefits of adjunctive therapy in comparison to conventional treatments for dry eye. Overall, this study will make an important contribution to the field of dry eye disease treatment by providing information on a novel approach to treating this condition. The results of the study will provide valuable information to both healthcare professionals and patients, and may lead to the development of new and improved treatment options for dry eye disease.
Interventions
Optimel Manuka+ eye drops (MelCare Biomedical Pty Ltd., Australia) is at present the only available manuka based eye drop commercially available in Australia. It is available both as 16% eye drop as well as 98% gel form. Presently, a growing number of studies are exploring ocular benefits of the drop, based on extensive evidence of antimicrobial, antioxidant, and anti-inflammatory effects of Manuka honey.
The Bruder Moist Heat Eye Compress (Optimed Pty Ltd., Australia) is commonly used as an e
Optimel Manuka+ eye drops (MelCare Biomedical Pty Ltd., Australia) is at present the only available manuka based eye drop commercially available in Australia. It is available both as 16% eye drop as well as 98% gel form. Presently, a growing number of studies are exploring ocular benefits of the drop, based on extensive evidence of antimicrobial, antioxidant, and anti-inflammatory effects of Manuka honey. The Bruder Moist Heat Eye Compress (Optimed Pty Ltd., Australia) is commonly used as an easy way to treat chronic dry eye, meibomian gland dysfunction (MGD) and blepharitis. The warm compress liquifies solidified meibum in the blocked meibomian glands which help to stabilise the tear film and slow tear evaporation. The compress is applied over closed eyes for 10 minutes after heating it for 20 seconds in the microwave to provide warmth. 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 (16%) 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 with the use of Bruder Moist Heat Eye Compress will be checked by directly asking the participants at Visit 2. Compliance with the use of the Optimel Manuka+ Dry Eye Drops will be monitored by measuring and recording the weight of 10 eye drop bottles to obtain an average weight prior to giving it to the participant. At Visit 2, the weight of the eye drop bottles will be measured again. The participants will receive weekly reminders to continue their treatment after they are enrolled in the study: a text message reminder will be sent out at Week 1 and Week 3, 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
1. 18 years of age or older 2. Able to read and comprehend English to provide informed consent, as demonstrated by signing a record of informed consent 3. In good general health 4. 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. 5. Have not used Optimel Manuka+ Dry Eye Drops in the past 3 months 6. Have not used warm compresses or lid scrubs in the past 1 month 7. Willing to discontinue their current use of any dry eye therapy 3 days prior to and throughout the study 8. Able to follow the visitation schedule and comply with the dosage as directed by the investigators 9. Willingness to notify the study investigators if instructed to alter their dietary intake of fish or omega-3 supplements by their health or medical practitioner
Exclusion criteria
1. Known allergy to benzoic acid preservatives (participants could be randomly assigned to the group using manuka honey eye drops, which uses benzoic acid as a preservative) 2. Known allergy to honey or bee products (participants could be randomly assigned to the group using manuka honey eye drops) 3. Active anterior eye disease/ infection, inflammation/allergy that requires ocular medical treatment (participants with an active eye infection may have a higher amount and variety of microorganisms, which may confound the study results) 4. 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; 5. Soft contact lens wear one week prior to the study or during the study (contact lens wearers may introduce other bacteria to the eyes, which may confound the study results) 6. Hard contact lens wear one month prior to the study and during the study (contact lens wearers may introduce other bacteria to the eyes, which may confound the study results) 7. Current typical dietary intake of fish or oral supplements known to have anti-inflammatory properties; 8. Use of eyelid cosmetics during the study (use of eyelid cosmetics may induce changes in ocular physiology and bacterial load, which may confound the study results) 9. 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; Use of fish oil or oral supplements known to have anti-inflammatory properties 10. 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 11. Epilepsy or history of migraines exacerbated by flashing, strobe-like lights 12. Pregnant or breastfeeding during the study (pregnancy and breastfeeding can alter tear film physiology, which may confound the study results) 13. 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