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Traditionally, Manuka honey has been used to combat against bacteria and reduce inflammation (the body's way of reacting to infection, irritation or other injury). Due to the inflammatory nature of dry eye, Manuka eye drops show promise as a treatment for dry eye disease. The aim of this research is to compare the effects of two over the counter eye drops that are used to treat dry eye conditions over a one month period.
The aim of the present study is to conduct a randomised clinical trial to compare the effect on tear film properties and dry eye signs and symptoms of Optimel Manuka eye drops compared to Systane Ultra, a widely available over the counter aqueous tear supplement as a control eye drop. This investigation will involve a minimum of 40 participants who have dry eye, who are randomly put into two groups receiving either Optimel Manuka drops or Systane Ultra used three times daily for one month. Both of these products are commercially available in Australia. Results from this study will inform practitioners as to the potential benefits of Manuka eye drops on tear film characteristics and signs and symptoms of dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manuka eye drops | Experimental |
| |
| Systane Ultra | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimel Antibacterial Manuka+ Dry Eye Drops | Other | Leptospermum sp Honey 165mg/g |
| |
| Measure | Description | Time Frame |
|---|---|---|
| A Measurable Difference in Tear Lipid Layer Thickness After 4 Weeks of Daily Use | The primary endpoint is a measurable difference in tear lipid layer thickness between Optimel Manuka eye drops and Systane Ultra eye drops after 4 weeks of daily use. Tear film inferior lipid layer thickness (LLT; nm) is measured using the LipiView II (Johnson and Johnson Vision, USA). 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. | 28 days |
| A Measurable Difference in Tear Evaporation Rate After 4 Weeks of Daily Use. | A measurable difference in Tear evaporation rate between Optimel Manuka eye drops and Systane Ultra eye drops after 4 weeks of daily use. Measured using a Modified Vapometer. 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. | 28 days |
| A Measurable Difference in Fluorescein Tear Break-up Time After 4 Weeks of Daily Use | A measurable difference in fluorescein tear break-up time between Optimel Manuka eye drops and Systane Ultra eye drops after 4 weeks of daily use. Fluorescein tear break-up time (TBUT; sec) (Opti-Strip-FL, Optimed, Lane Cove West, NSW, Australia) was 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. |
| Measure | Description | Time Frame |
|---|---|---|
| A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use | A measurable difference in subjective symptoms between Optimel Manuka eye drops and Systane Ultra eye drops after 4 weeks of daily use. Subjective symptoms is measured using an visual analogue scale ranging from 0 to 100, with higher scores meaning worse outcome. Participants are asked to visually represent their symptom severity by marking a dot on a line ten centimetres in length. These are then measured using a ruler to the nearest 0.5mm and given a score from zero to 100, with zero indicative of no symptoms and 100 suggesting maximum symptom severity |
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Inclusion Criteria:
Exclusion Criteria:
Allergy to benzoic acid preservatives;
Allergy to honey products;
Active anterior eye disease/ infection, inflammation/allergy that requires ocular medical treatment;
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;
Soft contact lens, rigid gas permeable, orthokeratology lens wearer within one week prior to the study and during the study.
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:
Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankolysing spondylitis, multiple sclerosis and systemic lupus erythematosis;
Epilepsy or history of migraines exacerbated by flashing, strobe-like lights.
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Tan, PhD | University of New South Wales | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry and Vision Science | Sydney | New South Wales | 2050 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31949092 | Derived | Tan J, Jia T, Liao R, Stapleton F. Effect of a formulated eye drop with Leptospermum spp honey on tear film properties. Br J Ophthalmol. 2020 Oct;104(10):1373-1377. doi: 10.1136/bjophthalmol-2019-315160. Epub 2020 Jan 16. |
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Study results will be made available in the form of summaries
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| ID | Title | Description |
|---|---|---|
| FG000 | Manuka Eye Drops | Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g |
| FG001 | Systane Ultra | Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Manuka Eye Drops | Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g |
| BG001 | Systane Ultra | Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | A Measurable Difference in Tear Lipid Layer Thickness After 4 Weeks of Daily Use | The primary endpoint is a measurable difference in tear lipid layer thickness between Optimel Manuka eye drops and Systane Ultra eye drops after 4 weeks of daily use. Tear film inferior lipid layer thickness (LLT; nm) is measured using the LipiView II (Johnson and Johnson Vision, USA). 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. | Posted | Mean | Standard Deviation | nm | 28 days |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Manuka Eye Drops | Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ocular Stinging | Eye disorders | Non-systematic Assessment | Stinging sensation of the eye |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jacqueline Tan | Eye Research Group, SOVS, UNSW Sydney | 02 9385 6551 | jacqueline.tan@unsw.edu.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2018 | Nov 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Systane Ultra Lubricating Eye Drops |
| Other |
Polyethylene glycol 400 0.4% and propylene glycol 0.3% |
|
| 28 days |
| 28 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ocular Surface Disease Index Score | 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. Those with an OSDI score of below 13 were excluded. | Mean | Standard Deviation | scores on a scale |
|
| OG001 |
| Systane Ultra |
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3% |
|
|
|
| Primary | A Measurable Difference in Tear Evaporation Rate After 4 Weeks of Daily Use. | A measurable difference in Tear evaporation rate between Optimel Manuka eye drops and Systane Ultra eye drops after 4 weeks of daily use. Measured using a Modified Vapometer. 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. | Posted | Mean | Standard Deviation | gm-2h | 28 days |
|
|
|
|
| Primary | A Measurable Difference in Fluorescein Tear Break-up Time After 4 Weeks of Daily Use | A measurable difference in fluorescein tear break-up time between Optimel Manuka eye drops and Systane Ultra eye drops after 4 weeks of daily use. Fluorescein tear break-up time (TBUT; sec) (Opti-Strip-FL, Optimed, Lane Cove West, NSW, Australia) was 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. | Posted | Mean | Standard Deviation | seconds | 28 days |
|
|
|
|
| Secondary | A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use | A measurable difference in subjective symptoms between Optimel Manuka eye drops and Systane Ultra eye drops after 4 weeks of daily use. Subjective symptoms is measured using an visual analogue scale ranging from 0 to 100, with higher scores meaning worse outcome. Participants are asked to visually represent their symptom severity by marking a dot on a line ten centimetres in length. These are then measured using a ruler to the nearest 0.5mm and given a score from zero to 100, with zero indicative of no symptoms and 100 suggesting maximum symptom severity | Posted | Mean | Standard Deviation | units on a scale | 28 days |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | Systane Ultra | Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3% | 0 | 21 | 0 | 21 | 0 | 21 |
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| Dryness |
|
| Blurry vision |
|
| Overall discomfort |
|
| 0.30 |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.66 | Dryness | Superiority |
| Wilcoxon (Mann-Whitney) | 0.14 | Blurred vision | Superiority |
| Wilcoxon (Mann-Whitney) | 0.30 | Overall discomfort | Superiority |