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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - Supplement
Treatment: Other - 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


Treatment: Other: 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

Treatment: Other: Placebo
polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subjective Ocular Symptoms
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
Subjective Ocular Comfort
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
Subjective Ocular Dryness
Timepoint [3] 0 0
3 months
Secondary outcome [1] 0 0
Non-invasive Tear Film Break-up Time
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Tear Evaporation Rate
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Tear Meniscus Height
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Tear Volume
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Tear Film Lipid Layer Thickness
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
Sex
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
21/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2018
Sample size
Target
Accrual to date
Final
119
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/study/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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03141931