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

NCT02295358 | Withdrawn

• 1 other identifier: 14-0235
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Effect of Omega-3 Fatty Acid Supplementation on Ocular Surface

  Change in Ocular Surface from baseline over 3 month

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Eye Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Leonard K Seibold, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

US (1)