Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000361606p
Ethics application status
Submitted, not yet approved
Date submitted
14/03/2023
Date registered
12/04/2023
Date last updated
29/05/2023
Date data sharing statement initially provided
12/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Hypochlorous Acid Spray on Ocular Symptoms and Eyelid Microbiota
Scientific title
The effect of hypochlorous acid spray on ocular symptoms and eyelid microbiota after 4 weeks of twice daily use in adults with and without dry eyes
Secondary ID [1] 309204 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye disease 329344 0
Condition category
Condition code
Eye 326287 326287 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325653 0
Treatment: Drugs
Comparator / control treatment
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. The non-dry eye group will act as the control arm for this study.
Control group
Active

Outcomes
Primary outcome [1] 334157 0
Ocular symptoms measured using the Ocular Surface Disease Index questionnaire.
Timepoint [1] 334157 0
One month post-intervention commencement.
Primary outcome [2] 334359 0
Ocular symptoms measured using the Visual Analogue Scale questionnaire.
Timepoint [2] 334359 0
One month post-intervention commencement.
Secondary outcome [1] 419521 0
Microbial contamination on the eyelid margin.
A sterile cotton bud moistened with saline will be used to swab the edge of the eyelid. Samples will be stored in a sterile vial and transferred to the Microbiology lab, where bacteria will be cultured and counted.
Timepoint [1] 419521 0
One month post-intervention commencement.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be summarised as means ± standard deviations for variables measured on an interval scale and paired t-tests will be used to compare outcome variables within subjects between the two visits. Unpaired t-tests will be used to compare outcome variables between subjects in the two groups. Statistical significance is set at p = 0.05. A regression model will be used to find a correlation between bacterial load and signs and symptoms of dry eye. No interim analysis is planned for the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 39829 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 313394 0
Commercial sector/Industry
Name [1] 313394 0
Optimed Pty Ltd
Country [1] 313394 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Rupert Myers Building, South wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 315159 0
None
Name [1] 315159 0
N/A
Address [1] 315159 0
N/A
Country [1] 315159 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312611 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 312611 0
Rupert Myers Building, South wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Ethics committee country [1] 312611 0
Australia
Date submitted for ethics approval [1] 312611 0
20/03/2023
Approval date [1] 312611 0
Ethics approval number [1] 312611 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125282 0
Dr Jacqueline Tan-Showyin
Address 125282 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Country 125282 0
Australia
Phone 125282 0
+61 293856551
Fax 125282 0
Email 125282 0
jacqueline.tan@unsw.edu.au
Contact person for public queries
Name 125283 0
Dr Jacqueline Tan-Showyin
Address 125283 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Country 125283 0
Australia
Phone 125283 0
+61 293856551
Fax 125283 0
Email 125283 0
jacqueline.tan@unsw.edu.au
Contact person for scientific queries
Name 125284 0
Dr Jacqueline Tan-Showyin
Address 125284 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Country 125284 0
Australia
Phone 125284 0
+61 293856551
Fax 125284 0
Email 125284 0
jacqueline.tan@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.