The effect of Optimel Manuka+ Dry Eye Drops with adjunctive treatment on signs and symptoms of dry eye

Not Applicable

Completed

• Conditions: Dry eye disease; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12621000336886
• Lead Sponsor: SW Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-24
• Study Completion: 2022-10-14
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

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.
•Have not used Optimel Manuka+ Dry Eye Drops in the past 3 months
•Have not used warm compresses or lid scrubs in the past 1 month
•Participant is willing to discontinue their current use of any rewetting/lubricating drops 3 days before the study and throughout the study;
•Willing to comply with the dosage and study visit schedule as directed by the investigator;
•Willing to notify the study investigator if instructed to alter their dietary intake of fish or omega-3 supplements 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 wearer within one week prior to the study and during the study.
•Rigid gas permeable, orthokeratology lens wear within 1 month prior to the study and during the study.
•Current typical dietary intake of fish or oral supplements known to have anti-inflammatory properties;
•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:
oOcular medication, category S3 and above;
oAny 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 ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus;
•Epilepsy or history of migraines exacerbated by flashing, strobe-like lights;
•The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is a measurable difference in tear break-up time between Optimel Manuka+ eye drops and adjunctive therapy after 4 weeks of daily use.<br>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.<br><br>[After 4 weeks of daily use]