NCT01102257

Dry Eye Assessment and Management: Feasibility Study

Clinical Trial of Essential Fatty Acids for Dry Eye Disease: Feasibility Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Asbell, Penny, M.D. · Individual
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DRUG	Omega-3 EFA Supplement	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
DRUG	Olive Oil	Placebo group will take 5 capsules a day containing 3.0 grams of olive oil

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-07-01
• Completion: 2011-03-01
• First posted: 2010-04-13
• Last updated: 2012-08-23
• Results posted: 2012-08-23

Locations

1 site across 1 country: United States