The Effects of Dietary Supplementation With Omega-3 Fatty Acids on Symptoms of Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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; polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nutraceutical supplement