N/A N=119 Randomized Double-blind Treatment

The Effects of Dietary Supplementation With Omega-3 Fatty Acids on Symptoms of Dry Eye

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT03141931 ↗

Enrolled (actual)

119

Serious AEs

0.0%

Results posted

Jun 2020

Primary outcome: Primary: Subjective Ocular Symptoms — 27.42; 27.43 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Supplement (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of New South Wales
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjective Ocular Symptoms	27.42; 27.43	—
PRIMARY Subjective Ocular Comfort	35.61; 35.66	—
PRIMARY Subjective Ocular Dryness	9.75; 9.78	—
SECONDARY Non-invasive Tear Film Break-up Time	11.50; 11.49	—
SECONDARY Tear Evaporation Rate	59.10; 59.11	—
SECONDARY Tear Meniscus Height	0.26; 0.27	—
SECONDARY Tear Volume	18.17; 18.13	—
SECONDARY Tear Film Lipid Layer Thickness	64.59; 64.84	—

Summary

The aim of this study is to compare ocular symptoms and signs when the test nutraceutical formulation (combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids) is consumed daily over a 3 month period, with a control capsule that contains polyethylene glycol (PEG), oleic acid and propylene glycol, which are found in many pharmaceutical products and are generally considered to be biologically inert and safe. There is good evidence that the consumption of oily fish has a protective effect against dry eye, and other studies have provided evidence of the beneficial effect of supplementation with omega-3 essential fatty acids in the treatment of dry eye disease. However, there have been limited well designed clinical trials investigating the potential for nutraceutical dietary supplementation to impact ocular comfort. To date, no controlled, randomised clinical trials have been conducted to evaluate the test nutraceutical formulation. Therefore, the purpose of this study is to conduct a randomized, placebo-controlled, double-masked study to investigate the effects of dietary supplementation with a combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids on ocular comfort including 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;
Be at least 18 years old;
Have symptoms of ocular discomfort as measured with the Ocular Surface Disease Index (OSDI) score of >12 at the Baseline visit;
Willing to comply with the dosage and study visit schedule as directed by the investigator;
No contact lens wear in the last 30 days and willing to refrain from contact lens wear for the duration of the study;
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;
Willingness to notify the study investigator if instructed to alter their diet by health/medical practitioner;
Willing to continue using any artificial tear supplements at the same frequency throughout the study, as used prior to the study
Have health and ocular health findings which would not prevent the participant from safely ingesting dietary supplementation with combination omega oils

Exclusion Criteria

Any systemic disease that would preclude participants from safely ingesting dietary supplementation with combination omega oils;
Self-reported allergy/sensitivity to any of the study product ingredients;
Use of any polyunsaturated fatty acid-containing dietary supplements (such as fish oil, evening primrose oil, linseed oil) up to 12 weeks prior to the start of 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;
Eye surgery within 6 months immediately prior to enrolment for this study;
Rigid or soft contact lens wearer, including orthokeratology in the last 30 days;
Previous corneal refractive surgery;
Pregnancy or breastfeeding.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03141931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.