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

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.

Study Overview

• Status: Withdrawn
• Conditions: Ocular Hypertension; Open Angle Glaucoma

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Leonard K Seibold, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: November 13, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Estimate): July 9, 2015
• Last Update Submitted That Met QC Criteria: July 8, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
• Other Study ID Numbers: 14-0235