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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03622619




Registration number
NCT03622619
Ethics application status
Date submitted
6/08/2018
Date registered
9/08/2018

Titles & IDs
Public title
The Effect of Manuka Eye Drops on Tear Film Properties
Scientific title
The Effect of Manuka Eye Drops on Tear Film Properties
Secondary ID [1] 0 0
SOVS2018-501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye Syndrome 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Optimel Antibacterial Manuka+ Dry Eye Drops
Other interventions - Systane Ultra Lubricating Eye Drops

Experimental: Manuka eye drops -

Active comparator: Systane Ultra -


Other interventions: Optimel Antibacterial Manuka+ Dry Eye Drops
Leptospermum sp Honey 165mg/g

Other interventions: Systane Ultra Lubricating Eye Drops
Polyethylene glycol 400 0.4% and propylene glycol 0.3%
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
A Measurable Difference in Tear Lipid Layer Thickness After 4 Weeks of Daily Use
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
A Measurable Difference in Tear Evaporation Rate After 4 Weeks of Daily Use.
Timepoint [2] 0 0
28 days
Primary outcome [3] 0 0
A Measurable Difference in Fluorescein Tear Break-up Time After 4 Weeks of Daily Use
Timepoint [3] 0 0
28 days
Secondary outcome [1] 0 0
A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use
Timepoint [1] 0 0
28 days

Eligibility
Key inclusion criteria
* 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;
* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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:

* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/10/2018
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
School of Optometry and Vision Science - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jacqueline Tan, PhD
Address 0 0
University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol Study Protocol and Statistical Analysis Plan
Statistical analysis plan Study Protocol and Statistical Analysis Plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03622619