Omega-3 Fatty Acid Supplements and Dry Eye
|Keratoconjunctivitis Sicca||Dietary Supplement: Omega-3 Fatty Acid Dietary Supplement: Soybean Soft Gels|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Omega-3 Fatty Acid Supplementation and Dry Eye|
- Change in Ocular Surface Disease Index (OSDI) [ Time Frame: Baseline, 4 weeks into treatment, 8 weeks into treatment ]Based on previous unpublished work by our group (and others), it is suggestive that a 10 unit change in OSDI score may be clinically meaningful. There currently is no accepted survey instrument to monitor change in DED clinical trials, although the OSDI has wide acceptance clinically. This study will help define what unit of change may be clinically and statistically acceptable for future trials.
- Changes in Osmolarity (TearLab) value [ Time Frame: Baseline, 4 weeks, 12 weeks ]The TearLab also has limited use in DED clinical trials. Our best estimate of a clinically meaningful change is 7 mOsm/kg (reported dry eye, 315mOsm/kg - reported normal, 308 mOsm/kg). Again, as this has never been assessed, these results here are pilot in nature.
- Changes in Staining scores [ Time Frame: Baseline, 4 weeks, 8 weeks ]Changes in average staining scores (average of 5 corneal regions; 6 conjunctival regions) and sum staining scores will be evaluated.
- Changes in Tear proteomics [ Time Frame: Baseline, 4 weeks, 8 weeks ]This portion of the study is exploratory in nature. iTRAQ proteomics using mass spectrometry and RayBiotech quantibody microarrays will be used evaluate changes in inflammatory mediators for future biomarker search and pathway analysis.
|Study Start Date:||May 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment Group
This group will receive Omega-3 EFA supplements for 8 weeks. They will take 4 capsules/day.
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:
Placebo Comparator: Placebo Group
This group will receive placebo supplements for 8 weeks. They will take 4 capsules a day.
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%).
Other Name: Placebo Soft Gels
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213342
|United States, Ohio|
|The Ohio State University College of Optometry|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Kelly K Nichols, OD, MPH, PhD||The Ohio State University College of Optometry|