None listed
Conditions
Brief summary
This project aims to examine the effect of Bruder Hygienic Eyelid Solution (Hypochlorous acid 0.02%) on ocular signs and symptoms, and eyelid microbiota in subjects with and without dry eye. This study seeks to examine: 1) The effect of a dilute hypochlorous acid (0.02%) spray on dry eye signs and symptoms and, 2) The correlation between eyelid microbiota and dry eye signs and symptoms. Study participants will attend two visits, an initial baseline visit and a 4-week follow-up visit. The OSDI score will be used to sort subjects into two groups: the dry eye group and the non-dry eye group. Participants scoring 0-12 points will be assigned to the non-dry eye group, whilst participants scoring above 12 will be assigned to the dry eye group. Both groups will receive Bruder Hygienic Eyelid Solution (Hypochlorous acid 0.02%) and participants will be instructed to use the spray twice daily on clean eyelids after normal face washing in the morning and night for 4 weeks.
Interventions
Hypochlorous acid 0.02% solution spray is a commercially available cosmetic product in Australia designed to relieve eyelid and eyelash discomfort. Participants who meet the eligibility criteria will be sorted into two groups: the dry eye group and the non-dry eye group. Participants scoring 0-12 points using the "Ocular Surface Disease Index" questionnaire will be assigned to the non-dry eye group, whilst participants scoring above 12 will be assigned to the dry eye group. Both groups will rece
Hypochlorous acid 0.02% solution spray is a commercially available cosmetic product in Australia designed to relieve eyelid and eyelash discomfort. Participants who meet the eligibility criteria will be sorted into two groups: the dry eye group and the non-dry eye group. Participants scoring 0-12 points using the "Ocular Surface Disease Index" questionnaire will be assigned to the non-dry eye group, whilst participants scoring above 12 will be assigned to the dry eye group. Both groups will receive Bruder Hygienic Eyelid Solution (Hypochlorous acid 0.02%) and participants will be instructed to use the spray twice daily on clean eyelids after normal face washing in the morning and night for 4 weeks. Compliance with the use of the Bruder Hygienic Eyelid Solution will be checked verbally by directly asking the participants at Visit 2 (4 weeks post-commencement of intervention) as well as by measuring and recording the weight of 10 solution bottles to obtain an average weight prior to giving it to the participant. At Visit 2, the weight of the solution bottles will be measured again.
Sponsors
UNSW Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Adults aged 18 years or older. • Able to read and comprehend English and provide informed consent by signing a record of informed consent. • Habitual visual acuity of at least 6/9 in each eye • Willingness to use hypochlorous acid spray on their eyelids twice daily for 4 weeks. • Willingness to attend two clinic visits at the School of Optometry and Vision Science • Willingness to not use any ocular lubricants and warm compresses for the duration of the study. • Willingness to not use eyelid cosmetics at the two visits.
Exclusion criteria
• Known allergy to hypochlorous acid (All participants will be using 0.02% hypochlorous acid on their eyelids) • Comorbid ocular surface disease other than dry eye e.g., microbial conjunctivitis, microbial keratitis (Comorbid ocular surface disease states may contribute to ocular signs and symptoms that may confound result findings) • Ocular surgery or trauma in the last 6 months (Ocular surgery or trauma can introduce bacteria that may confound study results. Hypochlorous acid may affect the bacterial balance of eyes recovering from ocular surgery or trauma) • Use of contact lenses in the last 4 weeks. (Contact lens use can introduce other bacteria which may confound study results) • Current use of ocular or systemic medications that may affect ocular microbiota, including antibiotics, immunosuppressants, and steroids. (Some medications may alter tear film physiology which may confound study findings) • Current use of lid hygiene products such as lid wipes, lid foams and lid sprays with the exception of standard make-up remover that does not contain tea tree oil. (Concurrent use of lid cleaning products would alter normal presence of bacteria and confound the study findings) • Autoimmune disease or immunosuppressive conditions such as eczema, and psoriasis. (Hypochlorous acid may have potential side effects in people with autoimmune disease due to its effect on bacteria) • Lactating or pregnant women (The effect of hypochlorous acid on lactating and pregnant women and the foetus are unknown) • History of migraine or epilepsy exacerbated by flashing lights (exposure to flashing lights during LipiView examination may trigger an episode or attack)
Outcome results
None listed