Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000257662p
Ethics application status
Not yet submitted
Date submitted
24/02/2023
Date registered
10/03/2023
Date last updated
16/03/2023
Date data sharing statement initially provided
10/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of adjunctive treatment using Bruder Moist Heat Eye Compresses + Optimel Manuka+ Dry Eye Drops on dry eye
Scientific title
Effect of adjunctive treatment using Bruder Moist Heat Eye Compresses + Optimel Manuka+ Dry Eye Drops on dry eye therapy in adults after four weeks of daily use
Secondary ID [1] 309078 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry eye 329138 0
Condition category
Condition code
Eye 326115 326115 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325517 0
Treatment: Devices
Intervention code [2] 325518 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control group will administer 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 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. 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.
Control group
Active

Outcomes
Primary outcome [1] 333984 0
The primary endpoint is a measurable difference in tear break-up time between Optimel Manuka+ eye drops and adjunctive therapy after 4 weeks of daily use. Fluorescein tear break-up time (TBUT; sec) (Opti-Strip-FL, Optimed, Lane Cove West, NSW, Australia) will be measured viewed with a yellow Wratten filter (No. 12, Kodak) and cobalt light of the slit lamp biomicroscope. Three consecutive TBUT measurements for each eye were taken by a single masked investigator.
Timepoint [1] 333984 0
After 4 weeks of daily use
Secondary outcome [1] 418945 0
A measurable difference in lipid layer thickness LipiView II Ocular Surface Interferometer (TearScience) will be used to measure the absolute thickness of the tear film lipid layer. The participant’s eye is positioned in front of an illumination source that is directed toward the tear film on the corneal surface. The camera records a 20-second video of the tear film interference and subsequently displays a value in interferometric colour units (ICU), where 1 ICU approximates 1nm of lipid layer thickness.
Timepoint [1] 418945 0
After 4 weeks of daily use
Secondary outcome [2] 418946 0
A measurable difference in tear evaporation rate The Modified Vapometer is a closed chamber device which is used for measuring transepidermal water loss. Participants will be seated upright on a chair and provided with a distance fixation target. To minimize the effect of skin evaporation, petroleum jelly (Vaseline, http://www.unilever.com.au/brands-in-action/detail/Vaseline/299339/) will be applied over the upper eyelid and the surrounding areas. The VapoMeter will then be placed over the eye and a non-invasive measurement of tear evaporation will be taken within 10 s. Participants will be instructed not to blink during open eye measurement and to maintain a normal straight gaze at the fixation target. Evaporation rates with the eyes closed will also be taken, in order to account for the skin evaporation from eyelids and surrounding skin tissue. Three sets of measurement will be taken for open and closed eyes, alternating between open and closed eyes. A photo capturing the anterior eye will also be taken for ocular surface area calculation.
Timepoint [2] 418946 0
After 4 weeks of daily use
Secondary outcome [3] 418947 0
A measurable difference in subjective questionnaire - Ocular surface disease index The Ocular Surface Disease Index (OSDI) dry eye questionnaire evaluated dry eye severity on a scale of 0 to 100, with higher scores representing greater severity of dry eye.
Timepoint [3] 418947 0
After 4 weeks of daily use

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

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)
To ensure that each participant has an equal chance of being placed in any group to start with (Optimel Manuka+ Dry Eye Drops with warm compresses or warm compresses alone, a computer allocates each study participant into a group randomly, like the flip of a coin. Once randomised participants will be allocated to one of the participant groups. The randomisation schedule will only be accessible by the unmasked investigator, and the unmasked investigator will provide instructions to the study participants as to the drop instillation technique and eye mask heating instruction and use. The masked investigator responsible for performing objective measurements will not be cognizant to the randomisation schedule and will not be present during the dispensing of the drops to maintain masking.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be assigned into their treatment group according to a randomization table generated using ((https://www.randomizer.org/), which will occur in chronological order of study enrolments.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
28/09/2023
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24129 0
School of Optometry and Vision Science - Kensington
Recruitment postcode(s) [1] 39638 0
2033 - Kensington

Funding & Sponsors
Funding source category [1] 313282 0
University
Name [1] 313282 0
UNSW Sydney
Country [1] 313282 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
School of Optometry & Vision Science, UNSW Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 315021 0
None
Name [1] 315021 0
Address [1] 315021 0
Country [1] 315021 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312512 0
UNSW HREC Committee
Ethics committee address [1] 312512 0
Ethics committee country [1] 312512 0
Australia
Date submitted for ethics approval [1] 312512 0
20/03/2023
Approval date [1] 312512 0
Ethics approval number [1] 312512 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124922 0
Dr Jacqueline Tan-Showyin
Address 124922 0
Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 124922 0
Australia
Phone 124922 0
+61 293856551
Fax 124922 0
Email 124922 0
[email protected]
Contact person for public queries
Name 124923 0
Jacqueline Tan-Showyin
Address 124923 0
Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 124923 0
Australia
Phone 124923 0
+61 293856551
Fax 124923 0
Email 124923 0
[email protected]
Contact person for scientific queries
Name 124924 0
Jacqueline Tan-Showyin
Address 124924 0
Level 3 North Wing Rupert Myers Building, Gate 14 Barker Street, UNSW Sydney NSW 2052 Australia
Country 124924 0
Australia
Phone 124924 0
+61 293856551
Fax 124924 0
Email 124924 0
[email protected]

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.