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

NCT03141931 | Completed Results

• 1 other identifier: SOVS2016-045
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye

Keywords

Nutraceutical supplement

Outcome Measures

Primary Outcomes (3)

• Subjective Ocular Symptoms

  Measured using the Ocular Surface Disease Index questionnaire. Ocular surface disease index is assessed on a scale of 0 to 100 with higher score representing greater disability. Scores can range from 10 to 100.

  3 months

• Subjective Ocular Comfort

  Measured using the Ocular Comfort Index questionnaire. Ocular comfort index questionnaire score range from 0 to 72. Lowest slow indicates better subjective symptoms.

  3 months

• Subjective Ocular Dryness

  Measured using the Dry Eye Questionnaire 5. Dry eye questionnaire 5 score ranges from 0 to 22. Lower score represents better outcome.

  3 months

Secondary Outcomes (5)

• Non-invasive Tear Film Break-up Time

  3 months

• Tear Evaporation Rate

  3 months

• Tear Meniscus Height

  3 months

• Tear Volume

  3 months

• Tear Film Lipid Layer Thickness

  3 months

Study Arms (2)

Supplement

EXPERIMENTAL

Combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids

Dietary Supplement: Supplement

Placebo

PLACEBO COMPARATOR

Polyethylene glycol, Oleic acid, Propylene glycol

Dietary Supplement: Placebo

Interventions

Supplement DIETARY_SUPPLEMENT

Concentrated Omega-3 Triglycerides-fish 332 mg Equiv. Eicosapentaenoic Acid (EPA) 134 mg Equiv. Docosahexaenoic Acid (DHA) 66.8 mg Flax Seed Oil (Linseed Oil) 334 mg Equiv. Oleic acid 58.5 mg Equiv. Linoleic acid 58.5 mg Equiv. Linolenic acid 192 mg Borago officinalis seed oil fixed (Borage) 434 mg Equiv. gamma-Linolenic acid 95.5 mg

Supplement

Placebo DIETARY_SUPPLEMENT

polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of New South Wales: lead

Study Sites (1)

School of Optometry and Vision Science

Sydney, New South Wales, 2052, Australia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

To manufacture the placebo soft gel capsule, inclusion of oleic acid in the formulation was required, which could have an influence on the placebo arm of the trial.

Results Point of Contact

• Title: Dr Jacqueline Tan
• Organization: University of New South Wales

jacqueline.tan@unsw.edu.au

+61 (02) 9385 6551

Study Officials

• Jacqueline Tan-Showyin, PhD

  University of New South Wales

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: May 5, 2017
• Study Start: August 21, 2017
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: June 11, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)