Dry Eye Assessment and Management: Feasibility Study
Condition: Dry Eye Syndromes; Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to test a protocol investigating the efficacy of omega-3 fatty
      acids in treating dry eye disease. The study is termed "feasibility" because its purpose is
      to demonstrate an ability to execute the proposed protocol with compliance at two sites
      rather than generate statistically relevant data concerning the safety and efficacy of the
      supplement in patients with dry eye disease.
    

Detailed description: 
      Dry eye disease (DED) is a common but often inadequately treated disease of the tears and
      surface of the eye. It can cause poor vision and chronic pain and is more frequent with
      increasing age. Inflammation may be an important component of this disease. This is supported
      by the observation that cyclosporine, a drug that targets the immune system, is approved for
      and effectively treats DED. Inflammatory processes likely produce ocular surface damage and
      contribute to chronic DED. Because not all people with DED respond to current
      anti-inflammatory treatments, other immune-modulating treatments would be of value.
      Furthermore, despite a great deal of evidence supporting DED as an inflammatory disease, not
      all researchers currently agree with this classification. More data that specifically
      measures inflammatory responses in DED needs to be collected in a well-characterized patient
      population and correlated with signs and symptoms of DED in order to improve our
      understanding and classification of the disease.

      Essential Fatty Acids (EFA) have been shown to diminish inflammatory responses in many human
      inflammatory diseases, and interest in the use of omega-3 and omega-6 fatty acids for disease
      treatment has resulted in several small studies as well as the use (and over-the-counter
      availability) of EFA-containing nutritional supplements, including several specifically for
      the treatment of DED. Despite this interest in EFA for DED, there are no strong empirical
      data from a well-controlled randomized controlled trial RCT supporting the use of EFA for
      DED. We postulate that DED is an inflammatory disease and hypothesize that EFA can mediate
      immune responses, thus improving DED signs, symptoms and associated measures of inflammation.
      The proposed three month feasibility study allows us the chance to demonstrate our ability to
      successfully execute our own protocol with compliance from the study patients before we begin
      the process of initiating a full-scale multi-center trial.
    

Intervention name(s): Omega-3 EFA Supplement; Olive Oil
Intervention type(s): Drug; Drug
Intervention description(s): The total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 EFAs comprised of:
2000 mg EPA 1000 mg DHA; Placebo group will take 5 capsules a day containing 3.0 grams of olive oil
Other intervention name(s): Fish oil supplements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dry Eye Disease; DED; Keratoconjunctivitis Sicca; Omega-3