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The Effect of Manuka Eye Drops on Tear Film Properties

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ClinicalTrials.gov Identifier: NCT03622619
Recruitment Status : Completed
First Posted : August 9, 2018
Results First Posted : January 27, 2021
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Jacqueline Tan-Showyin, The University of New South Wales

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dry Eye Syndrome
Interventions Other: Optimel Antibacterial Manuka+ Dry Eye Drops
Other: Systane Ultra Lubricating Eye Drops
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Manuka Eye Drops Systane Ultra
Hide Arm/Group Description Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
Period Title: Overall Study
Started 23 23
Completed 21 21
Not Completed 2 2
Arm/Group Title Manuka Eye Drops Systane Ultra Total
Hide Arm/Group Description Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3% Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
22.20  (3.47) 20.56  (3.16) 21.39  (3.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
12
  57.1%
16
  76.2%
28
  66.7%
Male
9
  42.9%
5
  23.8%
14
  33.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 21 participants 21 participants 42 participants
Asian
17
  81.0%
15
  71.4%
32
  76.2%
Non-Asian
4
  19.0%
6
  28.6%
10
  23.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 21 participants 21 participants 42 participants
21 21 42
Ocular Surface Disease Index Score (0-100)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 21 participants 21 participants 42 participants
33.65  (12.38) 28.17  (12.31) 30.91  (12.51)
[1]
Measure Description: higher values represent worse outcome (worse severity of dry eye)
1.Primary Outcome
Title A Measurable Difference in Tear Lipid Layer Thickness After 4 Weeks of Daily Use
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Manuka Eye Drops Systane Ultra
Hide Arm/Group Description:
Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: nm
-5.1  (22.2) -3.2  (21.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Manuka Eye Drops, Systane Ultra
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title A Measurable Difference in Tear Evaporation Rate After 4 Weeks of Daily Use.
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Manuka Eye Drops Systane Ultra
Hide Arm/Group Description:
Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: gm-2h
-10.8  (16.7) 0.7  (10.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Manuka Eye Drops, Systane Ultra
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title A Measurable Difference in Fluorescein Tear Break-up Time After 4 Weeks of Daily Use
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Manuka Eye Drops Systane Ultra
Hide Arm/Group Description:
Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: seconds
2.0  (3.0) 0.0  (3.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Manuka Eye Drops, Systane Ultra
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use
Hide Description 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
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Manuka Eye Drops Systane Ultra
Hide Arm/Group Description:
Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g
Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Burning/stinging -10.7  (23.2) -8.9  (18.6)
Grittiness/foreign body sensation -20.8  (20.4) -15.0  (17.9)
Dryness -35.4  (22.1) -32.2  (19.2)
Blurry vision -13.6  (22.5) -20.6  (29.8)
Overall discomfort -14.7  (15.1) -10.7  (17.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Manuka Eye Drops, Systane Ultra
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Burning/stinging
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Manuka Eye Drops, Systane Ultra
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Grittiness/foreign body sensation
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Manuka Eye Drops, Systane Ultra
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments Dryness
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Manuka Eye Drops, Systane Ultra
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments Blurred vision
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Manuka Eye Drops, Systane Ultra
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments Overall discomfort
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Manuka Eye Drops Systane Ultra
Hide Arm/Group Description Optimel Antibacterial Manuka+ Dry Eye Drops: Leptospermum sp Honey 165mg/g Systane Ultra Lubricating Eye Drops: Polyethylene glycol 400 0.4% and propylene glycol 0.3%
All-Cause Mortality
Manuka Eye Drops Systane Ultra
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/21 (0.00%)    
Hide Serious Adverse Events
Manuka Eye Drops Systane Ultra
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/21 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Manuka Eye Drops Systane Ultra
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/21 (4.76%)      0/21 (0.00%)    
Eye disorders     
Ocular Stinging * [1]  1/21 (4.76%)  1 0/21 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Stinging sensation of the eye
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Jacqueline Tan
Organization: Eye Research Group, SOVS, UNSW Sydney
Phone: 02 9385 6551
EMail: jacqueline.tan@unsw.edu.au
Layout table for additonal information
Responsible Party: Jacqueline Tan-Showyin, The University of New South Wales
ClinicalTrials.gov Identifier: NCT03622619    
Other Study ID Numbers: SOVS2018-501
First Submitted: August 6, 2018
First Posted: August 9, 2018
Results First Submitted: November 9, 2020
Results First Posted: January 27, 2021
Last Update Posted: January 27, 2021