The Effect of Omega-3 Fatty Acid Supplementation on Intraocular Pressure & Ocular Surface

Withdrawn

Brief Summary: This study is designed with the intention to further elucidate the effects of omega-3 fatty acids on intraocular pressure (IOP) and signs/symptoms of dry eye. Prior studies have shown statistically significant lowering of IOP with use of omega-3 fatty acids but have only been performed in animal models. This study will be the first to attempt replication in human models. A limited number of studies have shown an increase in tear production/volume as well as a decrease in the subjective symptoms of dry eye, but more studies are needed to better define these effects. Better understanding of the effects of this supplement on intraocular pressure and dry eye will contribute to the expanding knowledge about the pathophysiology of glaucoma/ocular hypertension and dry eye syndrome and potentially lead to further studies about new potential treatment options for these conditions.

Detailed Description: The purpose of this research project is to determine the effects of omega-3 fatty acid supplementation on intraocular pressure (IOP) as well as the signs and symptoms of dry eye. We hypothesize that dietary omega-3 fatty acid supplementation will be associated with a significant change in intraocular pressure compared to baseline measurements prior to beginning supplementation. We further hypothesize that omega-3 fatty acid supplementation will be associated with a significant increase in tear production and volume as well as a significant change in patients' subjective complaints of dry eye.

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of Ocular Hypertension or Open Angle Glaucoma of mild to moderate severity, with or without previously diagnosed dry eye syndrome, who are currently on monotherapy with a prostaglandin analog.
Age 40-89 of either gender, of any race/ethnicity

Exclusion Criteria

Females who are currently pregnant or planning to become pregnant during the study period
Age <40 years old
Diagnosis of any other form of glaucoma other than open-angle
Patients with known hypersensitivity (i.e., anaphylactic reaction) to omega-3 fatty acids or any of its components
Patients with cirrhosis or with known liver disease
Patients with diagnosed celiac disease
Patients with a hypersensitivity to fish or shellfish
Patients with paroxysmal or persistent atrial fibrillation
Patients who are currently using medical or recreational marijuana
Patients currently on any anticoagulation therapy including warfarin, dabigatran, apixaban, rivaroxaban, clopidogrel, cilostazol, dipyridamole, prasugrel, ticlopidine, ticagrelor
Patients currently on Lovaza, an omega- 3 fatty acid supplement requiring a prescription
Patients with any recent ocular surgery or laser treatment within 3 months

Primary Outcome Measures

Name	Time	Method
The Effect of Omega-3 Fatty Acid Supplementation on Intraocular Pressure	Change in intraocular pressure from baseline over 3 month	Intraocular pressure is measured at the study start, and after three month on supplementation.

Secondary Outcome Measures

Name	Time	Method
The Effect of Omega-3 Fatty Acid Supplementation on Ocular Surface	Change in Ocular Surface from baseline over 3 month	Tear breakup time, corneal fluorescein staining, and tear osmolarity of Ocular Surface is measured at the study start, and after three month on supplementation

Locations (1): University of Colorado Eye Center
🇺🇸
Aurora, Colorado, United States

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