Trial Outcomes & Findings for The Effect of Manuka Eye Drops on Tear Film Properties (NCT NCT03622619)
NCT ID: NCT03622619
Last Updated: 2021-05-18
Results Overview
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.
COMPLETED
NA
46 participants
28 days
2021-05-18
Participant Flow
Participant milestones
| Measure |
Manuka Eye Drops
Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
|
Systane Ultra
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Manuka Eye Drops on Tear Film Properties
Baseline characteristics by cohort
| Measure |
Manuka Eye Drops
n=21 Participants
Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
|
Systane Ultra
n=21 Participants
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.20 years
STANDARD_DEVIATION 3.47 • n=99 Participants
|
20.56 years
STANDARD_DEVIATION 3.16 • n=107 Participants
|
21.39 years
STANDARD_DEVIATION 3.39 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
|
17 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Asian
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
21 participants
n=99 Participants
|
21 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Ocular Surface Disease Index Score
|
33.65 scores on a scale
STANDARD_DEVIATION 12.38 • n=99 Participants
|
28.17 scores on a scale
STANDARD_DEVIATION 12.31 • n=107 Participants
|
30.91 scores on a scale
STANDARD_DEVIATION 12.51 • n=206 Participants
|
PRIMARY outcome
Timeframe: 28 daysThe 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.
Outcome measures
| Measure |
Manuka Eye Drops
n=21 Participants
Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
|
Systane Ultra
n=21 Participants
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
|
|---|---|---|
|
A Measurable Difference in Tear Lipid Layer Thickness After 4 Weeks of Daily Use
|
-5.1 nm
Standard Deviation 22.2
|
-3.2 nm
Standard Deviation 21.8
|
PRIMARY outcome
Timeframe: 28 daysA 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.
Outcome measures
| Measure |
Manuka Eye Drops
n=21 Participants
Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
|
Systane Ultra
n=21 Participants
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
|
|---|---|---|
|
A Measurable Difference in Tear Evaporation Rate After 4 Weeks of Daily Use.
|
-10.8 gm-2h
Standard Deviation 16.7
|
0.7 gm-2h
Standard Deviation 10.8
|
PRIMARY outcome
Timeframe: 28 daysA 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.
Outcome measures
| Measure |
Manuka Eye Drops
n=21 Participants
Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
|
Systane Ultra
n=21 Participants
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
|
|---|---|---|
|
A Measurable Difference in Fluorescein Tear Break-up Time After 4 Weeks of Daily Use
|
2.0 seconds
Standard Deviation 3.0
|
0.0 seconds
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 28 daysA 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
Outcome measures
| Measure |
Manuka Eye Drops
n=21 Participants
Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
|
Systane Ultra
n=21 Participants
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
|
|---|---|---|
|
A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use
Burning/stinging
|
-10.7 units on a scale
Standard Deviation 23.2
|
-8.9 units on a scale
Standard Deviation 18.6
|
|
A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use
Grittiness/foreign body sensation
|
-20.8 units on a scale
Standard Deviation 20.4
|
-15.0 units on a scale
Standard Deviation 17.9
|
|
A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use
Dryness
|
-35.4 units on a scale
Standard Deviation 22.1
|
-32.2 units on a scale
Standard Deviation 19.2
|
|
A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use
Blurry vision
|
-13.6 units on a scale
Standard Deviation 22.5
|
-20.6 units on a scale
Standard Deviation 29.8
|
|
A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use
Overall discomfort
|
-14.7 units on a scale
Standard Deviation 15.1
|
-10.7 units on a scale
Standard Deviation 17.5
|
Adverse Events
Manuka Eye Drops
Systane Ultra
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Manuka Eye Drops
n=21 participants at risk
Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
|
Systane Ultra
n=21 participants at risk
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
|
|---|---|---|
|
Eye disorders
Ocular Stinging
|
4.8%
1/21 • Number of events 1 • 3 months
|
0.00%
0/21 • 3 months
|
Additional Information
Dr Jacqueline Tan
Eye Research Group, SOVS, UNSW Sydney
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place