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
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndrome||Other: Optimel Antibacterial Manuka+ Dry Eye Drops Other: Systane Ultra Lubricating Eye Drops||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effect of Manuka Eye Drops on Tear Film Properties|
|Actual Study Start Date :||August 13, 2018|
|Actual Primary Completion Date :||October 30, 2018|
|Actual Study Completion Date :||October 30, 2018|
|Experimental: Manuka eye drops||
Other: Optimel Antibacterial Manuka+ Dry Eye Drops
Leptospermum sp Honey 165mg/g
|Active Comparator: Systane Ultra||
Other: 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 [ 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.
- A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use [ Time Frame: 28 days ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622619
|Australia, New South Wales|
|School of Optometry and Vision Science|
|Sydney, New South Wales, Australia, 2050|
|Principal Investigator:||Jacqueline Tan, PhD||University of New South Wales|