Clinical trial NCT03622619: The Effect of Manuka Eye Drops on Tear Film Properties
Official title: The Effect of Manuka Eye Drops on Tear Film Properties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The aim of the present study is to conduct a randomised clinical trial to compare the effect on tear film properties and dry eye signs and symptoms of Optimel Manuka eye drops compared to Systane Ultra, a widely available over the counter aqueous tear supplement as a control eye drop. This investigation will involve a minimum of 40 participants who have dry eye, who are randomly put into two groups receiving either Optimel Manuka drops or Systane Ultra used three times daily for one month. Both of these products are commercially available in Australia. Results from this study will inform practitioners as to the potential benefits of Manuka eye drops on tear film characteristics and signs and symptoms of dry eye.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: A Measurable Difference in Tear Lipid Layer Thickness After 4 Weeks of Daily Use
timeFrame: 28 days
measure: A Measurable Difference in Tear Evaporation Rate After 4 Weeks of Daily Use.
timeFrame: 28 days
measure: A Measurable Difference in Fluorescein Tear Break-up Time After 4 Weeks of Daily Use
timeFrame: 28 days
Secondary outcomes:
measure: A Measurable Difference in Subjective Symptoms After 4 Weeks of Daily Use
timeFrame: 28 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: School of Optometry and Vision Science
state: New South Wales
Study officials:
affiliation: University of New South Wales
name: Jacqueline Tan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan J, Jia T, Liao R, Stapleton F. Effect of a formulated eye drop with Leptospermum spp honey on tear film properties. Br J Ophthalmol. 2020 Oct;104(10):1373-1377. doi: 10.1136/bjophthalmol-2019-315160. Epub 2020 Jan 16.