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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03141931




Registration number
NCT03141931
Ethics application status
Date submitted
6/02/2017
Date registered
5/05/2017
Date last updated
11/06/2020

Titles & IDs
Public title
The Effects of Dietary Supplementation With Omega-3 Fatty Acids on Symptoms of Dry Eye
Scientific title
The Effects of Dietary Supplementation With a Combination of Flaxseed Oil, Borage Oil and Fish Oil Omega-3 Fatty Acids on Ocular Comfort Including Symptoms of Dry Eye
Secondary ID [1] 0 0
SOVS2016-045
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Eye 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 - Supplement
Other interventions - Placebo

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

Placebo Comparator: Placebo - Polyethylene glycol, Oleic acid, Propylene glycol


Other interventions: 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

Other interventions: Placebo
polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
3 months
Secondary outcome [1] 0 0
Non-invasive Tear Film Break-up Time - Measured in seconds using the Oculus Keratograph. Higher value represents better outcome.
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Tear Evaporation Rate - Measured in g.m^2.h using the Vapometer
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Tear Meniscus Height - Measured in millimeters using the Oculus Keratograph 5M
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Tear Volume - Measured in millimeters using phenol red thread tests
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Tear Film Lipid Layer Thickness - Measured in nanometers using the LipiView ocular surface interferometer
Timepoint [5] 0 0
3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
2052 - Sydney

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03141931
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jacqueline Tan-Showyin, 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

Summary results
Other publications