CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 119 enrolled
Drug / intervention
Supplement +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03141931
NCT03141931N/ACompleted

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

The University of New South Wales·interventional·Posted May 5, 2017·Updated Jun 11, 2020

In Brief

A clinical study evaluating Supplement and Placebo for Dry Eye. Completed, enrolled 119 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesAustralia
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 5, 2017
Enrollment StartAug 21, 2017
Primary CompletionOct 19, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.2 years ago

Interventions

Supplementdietary

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

Placebodietary

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