NCT01213342

Omega-3 Fatty Acid Supplements and Dry Eye

Omega-3 Fatty Acid Supplementation and Dry Eye

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Omega-3 fatty acids have been associated with a decline in inflammation. As dry eye disease is associated with inflammation of the ocular surface (DEWS report, Ocular Surface, 2007), the investigators hypothesize that the omega-3 fatty acid supplements used in this study will help to improve dry eye signs, such as eye surface irritation (staining) and tear film osmolarity, which is an overall measure of tear film stability and dry eye status. Further, the investigators hypothesize that dry eye symptoms, the end result of dry eye disease, such as discomfort and burning, will also improve with supplementation.

Detailed description

Dry Eye is a disorder of the tear film due to tear deficiency or excessive tear evaporation which causes damage to the exposed ocular surface and is associated with symptoms of ocular discomfort. If left untreated, severe dry eyes can lead to desiccation of the corneal epithelium, increased discomfort and sometimes loss of vision. Abundant evidence from animal models and clinical evaluations confirm that inflammation is an integral part of all moderate and severe Dry Eye Disease (DED) states and is likely to be significant in the pathogenesis leading to the chronicity of DED. Omega-3 essential fatty acids (EFAs) have been shown to have anti-inflammatory effects and inhibit multiple aspects of inflammatory response. DED is a common and growing problem as our population ages, causing chronic pain and visual disturbance that is not adequately treated with current approaches. If left untreated, severe dry eyes can lead to desiccation of the corneal epithelium, increased discomfort and sometimes loss of vision.The benefits are the possibility of alleviating or eliminating these symptoms of DED and the clinical data that will be gained on the safety and efficacy of omega-3s, which are already being marketed over-the-counter for the treatment of DED without any hard scientific data. The potential benefits of treatment outweigh the minimal risk of participation. This study hopes to discover more about the efficacy and tolerability of omega-3 EFA's in the treatment of dry eye and ocular surface disease.

Conditions

• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omega-3 Fatty Acid	Each patient will be instructed to take 4 soft gel capsules per day (2 with the morning meal and 2 with the evening meal). They will continue this regimen for 8 weeks. The total daily amount included in 4 soft gels includes: * EPA (Eicosapentaenoic Acid) 1300mg * DHA (Docosahexaenoic Acid) 900 mg * Other Omega-3's 360mg * Total Omega 3's 2560 mg
DIETARY_SUPPLEMENT	Soybean Soft Gels	Each patient will be instructed to take 4 soft gel capsules per day (2 with the morning meal and 2 with the evening meal. The main ingredient in the placebos is soybean oil (95.6%).

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-10-04
• Last updated: 2012-03-20

Locations

1 site across 1 country: United States