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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.
Full description
This study will be a prospective, randomised, placebo-controlled, double masked study conducted over a 3-month period. One hundred and thirty-eight (138) participants who meet the inclusion / exclusion criteria and give informed consent will be randomised to either the test capsules containing a combination of flaxseed oil, borage oil and fish oil omega-3 fatty acids or placebo capsules, identical in appearance, containing polyethylene glycol, oleic acid and propylene glycol (found in many pharmaceutical products and considered to be biologically inert and safe) to be taken by mouth three times daily for 40 days, and then twice daily thereafter for approximately 50 days. Every effort will be made to stratify enrolment by disease severity to ensure participants with mild, moderate and severe dry eye are represented in the study population. Stratification will be in a 2:2:1 fashion i.e. OSDI score >12 (55 participants), OSDI score >20 (55 participants) and OSDI score >45 (28 participants). Participants will be stratified according to dry eye severity prior to randomisation. There will be a total of 3 scheduled study visits over a period of approximately 3 months - Day 1, 1 month and 3 months. Ocular comfort and symptoms of dry eye will be assessed via questionnaires. The tear film and ocular surface will be assessed using specialised instruments including the slit lamp biomicroscope, Lipiview Ocular Surface Interferometer, Vapometer and Oculus Keratograph 5M, and stains. Safety will be assessed through measurement of vision, ocular redness and evaluation of the ocular surface using the slit lamp biomicroscope. Those participants who meet the eligibility criteria will be randomly allocated to either the test or control capsules. An adequate supply of capsules will be dispensed to last until the next Participants will be instructed to ingest one capsule three times daily with meals for 40 days, and then two times daily until their final 3 month study visit.
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Inclusion criteria
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:
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.
Primary purpose
Allocation
Interventional model
Masking
119 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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