Dry Eye SyndromeNCT03622619

The Effect of Manuka Eye Drops on Tear Film Properties

A study testing Optimel Antibacterial Manuka+ Dry Eye Drops and Systane Ultra Lubricating Eye Drops in people with Dry Eye Syndrome, run by The University of New South Wales at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndrome
What is being tested?: Optimel Antibacterial Manuka+ Dry Eye Drops and Systane Ultra Lubricating Eye Drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 1 siteAustralia
Study dates: 13 Aug 2018to 30 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
General population aged 18 years and over;
In good general health;
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 (1).
Willing to discontinue CL wear for 1 week before first visit and continue to do so until the conclusion of the study;
Participant is willing to discontinue their use of any previous conventional dry eye treatment method commenced before the study throughout the study;

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Willing to comply with the dosage and study visit schedule as directed by the investigator;
No planned changes to diet and willing not to substantially alter their usual diet for the duration of the study, including their typical intake of fish, green tea or oral supplements known to have anti-inflammatory properties;
Willingness to notify the study investigator if instructed to alter their diet by health/medical practitioner.

Who cannot join

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:

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Ocular medication, category S3 and above;
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;
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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

School of Optometry and Vision Science
Sydney, New South Wales, 2050

Other trials in Australia

About this study

Read the detailed description

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.

Conditions: Dry Eye Syndrome
Being tested: Optimel Antibacterial Manuka+ Dry Eye Drops, Systane Ultra Lubricating Eye Drops
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Optimel Antibacterial Manuka+ Dry Eye DropsOther
Leptospermum sp Honey 165mg/g
Systane Ultra Lubricating Eye DropsOther
Polyethylene glycol 400 0.4% and propylene glycol 0.3%

Study groups in NCT03622619
Study group	Role	What they receive
Manuka eye drops	Experimental	Not described Receives: Other: Optimel Antibacterial Manuka+ Dry Eye Drops
Systane Ultra	Active comparator	Not described Receives: Other: Systane Ultra Lubricating Eye Drops

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 28 days

Secondary outcomes (1)

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
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Aug 201830 Oct 2018

First posted9 Aug 2018
Study start13 Aug 2018
Primary completion30 Oct 2018
Study completion30 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03622619
Sponsor's protocol ID: SOVS2018-501
Status last verified: Apr 2021
First submitted: 6 Aug 2018
Last updated: 18 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Study results will be made available in the form of summaries

Publications

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.
PubMed 31949092

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Manuka Eye Drops on Tear Film Properties
ClinicalTrials.gov ID: NCT03622619
Acronym / sponsor ID: SOVS2018-501
Conditions: Dry Eye Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: The University of New South WalesUniversity, hospital or other
Study start: 13 Aug 2018 (actual)
Primary completion: 30 Oct 2018 (actual)
Study completion: 30 Oct 2018 (actual)
First posted: 9 Aug 2018 (actual)
Results: Posted 27 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Manuka eye drops	Experimental	Other: Optimel Antibacterial Manuka+ Dry Eye Drops
Systane Ultra	Active comparator	Other: Systane Ultra Lubricating Eye Drops

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
General population aged 18 years and over;
In good general health;
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 (1).
Willing to discontinue CL wear for 1 week before first visit and continue to do so until the conclusion of the study;

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Optimel Antibacterial Manuka+ Dry Eye DropsLeptospermum sp Honey 165mg/g	Other	Manuka eye drops
Systane Ultra Lubricating Eye DropsPolyethylene glycol 400 0.4% and propylene glycol 0.3%	Other	Systane Ultra

Primary outcome

A Measurable Difference in Tear Lipid Layer Thickness After 4 Weeks of Daily Use
Time frame: 28 days
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.
A Measurable Difference in Tear Evaporation Rate After 4 Weeks of Daily Use.
Time frame: 28 days
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.
A Measurable Difference in Fluorescein Tear Break-up Time After 4 Weeks of Daily Use
Time frame: 28 days
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.

1 secondary outcome

A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use
Time frame: 28 days

Results and safety

Results posted to the registry on 27 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Manuka Eye Drops	23	21
Systane Ultra	23	21

Primary outcome: A Measurable Difference in Tear Lipid Layer Thickness After 4 Weeks of Daily Use

Time frame: 28 days. Mean (Standard Deviation). Unit: nm

Measure	Manuka Eye Drops n = 21	Systane Ultra n = 21
Value	-5.1 (22.2)	-3.2 (21.8)

Manuka Eye Drops vs Systane Ultra: p = 0.65, Wilcoxon (Mann-Whitney)

Primary outcome: A Measurable Difference in Tear Evaporation Rate After 4 Weeks of Daily Use.

Time frame: 28 days. Mean (Standard Deviation). Unit: gm-2h

Measure	Manuka Eye Drops n = 21	Systane Ultra n = 21
Value	-10.8 (16.7)	0.7 (10.8)

Manuka Eye Drops vs Systane Ultra: p = 0.014, Wilcoxon (Mann-Whitney)

Primary outcome: A Measurable Difference in Fluorescein Tear Break-up Time After 4 Weeks of Daily Use

Time frame: 28 days. Mean (Standard Deviation). Unit: seconds

Measure	Manuka Eye Drops n = 21	Systane Ultra n = 21
Value	2.0 (3.0)	0.0 (3.1)

Manuka Eye Drops vs Systane Ultra: p = 0.055, Wilcoxon (Mann-Whitney)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Manuka Eye Drops	0 of 21 (0%)	1 of 21 (4.8%)	0 of 21
Systane Ultra	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31949092Tan 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.
Individual participant dataSharing planned: No. Study results will be made available in the form of summaries

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jacqueline Tan, PhD principal investigator

University of New South Wales

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Optimel Antibacterial Manuka+ Dry Eye Drops and Systane Ultra Lubricating Eye Drops in people with Dry Eye Syndrome, run by The University of New South Wales at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A Measurable Difference in Tear Lipid Layer Thickness After 4 Weeks of Daily Use (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03622619, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.