Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000334707
Ethics application status
Approved
Date submitted
18/02/2022
Date registered
23/02/2022
Date last updated
27/01/2023
Date data sharing statement initially provided
23/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of eyelid wipes with Manuka honey on ocular signs and symptoms
Scientific title
Effect of eyelid wipes with Manuka honey on ocular signs and symptoms in individuals with dry eye
Secondary ID [1] 306472 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eyes 325332 0
Condition category
Condition code
Eye 322717 322717 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eyelid wipes with Manuka honey (Blephadex Pro).
Participants will be instructed to clean their eyelids with a fresh wipe (one wipe for both eyelids), once daily in the morning for the duration of the study (one month).
Participants will be asked to return unused wipes at the follow-up visit to monitor for compliance.
Intervention code [1] 322899 0
Treatment: Other
Comparator / control treatment
Standard eyelid wipes without Manuka honey (Blephadex).
Participants will be instructed to clean their eyelids with a fresh wipe (one wipe for both eyelids), once daily in the morning for the duration of the study (one month).
Participants will be asked to return unused wipes at the follow-up visit to monitor for compliance.
Control group
Active

Outcomes
Primary outcome [1] 330515 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] 330515 0
One month post-intervention commencement.
Secondary outcome [1] 406500 0
Ocular symptoms measured using the Ocular Surface Disease Index questionnaire.
Timepoint [1] 406500 0
One month post-intervention commencement.

Eligibility
Key inclusion criteria
• Adult aged 18 years of older
• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent
• Symptoms of dry eye (OSDI questionnaire score of >12)
• At least one sign of dry eye in one eye (e.g. blocked oil-producing gland on the eyelid margin, average fluorescein tear break-up time <10 seconds)
• Willingness to not change usage frequency and type of any currently used products for the treatment of dry eye for the duration of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Known allergy to honey/bee products
• Hard contact lens wear one month prior to baseline and during the study, or soft contact lens wear one week prior to baseline and during the study
• Use of eyelid cosmetics during the study
• Have autoimmune disease or other systemic disease that may have an impact on tear film properties
• Use of any medication (eg. anti-inflammatory, anti-infectives or immunosuppressives) that may have an effect on ocular physiology and/or function during the study
• Active eye infection
• Use of Blephadex Pro eyelid wipes or any other ocular treatments (topical drops or creams) containing Manuka honey within 2 weeks prior to the Screening visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model analysis will be used to compare the treatments over time. The p value is set at p<0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
2/05/2022
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
31/01/2024
Actual
Sample size
Target
48
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 36832 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 310820 0
Commercial sector/Industry
Name [1] 310820 0
Optimed Pty Ltd
Country [1] 310820 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] 312071 0
None
Name [1] 312071 0
N/A
Address [1] 312071 0
N/A
Country [1] 312071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310386 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 310386 0
Rupert Myers Building, South wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Ethics committee country [1] 310386 0
Australia
Date submitted for ethics approval [1] 310386 0
28/02/2022
Approval date [1] 310386 0
01/04/2022
Ethics approval number [1] 310386 0

Summary
Brief summary
The purpose of this study is to compare the effect of eyelid wipes with and without Manuka honey in order to ascertain whether the Manuka honey (in the form of eyelid wipes) provides any potential benefits to patients with dry eye. Participants will be randomly assigned to use either the test eyelid wipes with Manuka honey or the control standard eyelid wipes without Manuka honey once daily for one month. Measurements of ocular signs and symptoms will be collected before and after one month of treatment, and the results between treatment groups will be compared.
The hypothesis is that the eyelid wipes with Manuka honey will reduce the amount of bacteria on the eyelid more than the standard eyelid wipes, and consequently improve other signs and symptoms of dry eye.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117474 0
Dr Jacqueline Tan-Showyin
Address 117474 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Country 117474 0
Australia
Phone 117474 0
+61 29385 6551
Fax 117474 0
Email 117474 0
jacqueline.tan@unsw.edu.au
Contact person for public queries
Name 117475 0
Dr Jacqueline Tan-Showyin
Address 117475 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Country 117475 0
Australia
Phone 117475 0
+61 29385 6551
Fax 117475 0
Email 117475 0
jacqueline.tan@unsw.edu.au
Contact person for scientific queries
Name 117476 0
Dr Jacqueline Tan-Showyin
Address 117476 0
Level 3, Rupert Myers Building, North wing
Gate 14, Barker St.
UNSW Sydney
NSW 2052
Country 117476 0
Australia
Phone 117476 0
+61 29385 6551
Fax 117476 0
Email 117476 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
Data sharing requires approval from ethics and participants. Approval to share data cannot be assumed until the trial is approved by ethics, and participants sign the consent form. Furthermore, consent to share data is optional for participants. Therefore, I have selected "no".


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.