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NCT03622619

The Effect of Manuka Eye Drops on Tear Film Properties

Completed NA Results posted Last updated 18 May 2021
What this trial tests

NA trial testing Optimel Antibacterial Manuka+ Dry Eye Drops in Dry Eye Syndrome in 46 participants. Completed in 30 October 2018.

Timeline
13 August 2018
Primary endpoint
30 October 2018
30 October 2018

Quick facts

Lead sponsorThe University of New South Wales
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment46
Start date13 August 2018
Primary completion30 October 2018
Estimated completion30 October 2018
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

Sponsor

The University of New South Wales

Who can join

18 and older, any sex, with Dry Eye Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

A Measurable Difference in Tear Lipid Layer Thickness After 4 Weeks of Daily Use Primary · 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 la

GroupValue95% CI
Manuka Eye Drops-5.1± 22.2
Systane Ultra-3.2± 21.8
A Measurable Difference in Tear Evaporation Rate After 4 Weeks of Daily Use. Primary · 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 the

GroupValue95% CI
Manuka Eye Drops-10.8± 16.7
Systane Ultra0.7± 10.8
A Measurable Difference in Fluorescein Tear Break-up Time After 4 Weeks of Daily Use Primary · 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.

GroupValue95% CI
Manuka Eye Drops2.0± 3.0
Systane Ultra0.0± 3.1
A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use Secondary · 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

Burning/stinging
GroupValue95% CI
Manuka Eye Drops-10.7± 23.2
Systane Ultra-8.9± 18.6
Grittiness/foreign body sensation
GroupValue95% CI
Manuka Eye Drops-20.8± 20.4
Systane Ultra-15.0± 17.9
Dryness
GroupValue95% CI
Manuka Eye Drops-35.4± 22.1
Systane Ultra-32.2± 19.2
Blurry vision
GroupValue95% CI
Manuka Eye Drops-13.6± 22.5
Systane Ultra-20.6± 29.8
Overall discomfort
GroupValue95% CI
Manuka Eye Drops-14.7± 15.1
Systane Ultra-10.7± 17.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Manuka Eye Drops
Serious: 0/21 (0%)
Deaths: 0/21
Systane Ultra
Serious: 0/21 (0%)
Deaths: 0/21
Other adverse events (1 terms — click to expand)

ReactionSystemManuka Eye DropsSystane Ultra
Ocular StingingEye disorders

Data from ClinicalTrials.gov NCT03622619 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effect of a formulated eye drop with <i>Leptospermum</i> spp honey on tear film properties.
    Tan J, Jia T, Liao R, Stapleton F. · · 2020 · cited 12× · PMID 31949092 · DOI 10.1136/bjophthalmol-2019-315160
  2. Clinical Measurement of Transepidermal Water Loss.
    Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148

Verify or expand the search:

Other recruiting trials for Dry Eye Syndrome

Currently open trials in the same condition.

Other The University of New South Wales trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03622619.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing