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

NCT ID: NCT02295358

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-11-30

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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonard K Seibold, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Eye Center

Aurora, Colorado, United States

Countries

United States

Other Identifiers

14-0235

Identifier Type: -

Identifier Source: org_study_id