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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02295358
• Other study ID #: 14-0235
• Status: Withdrawn
• Phase: N/A
• First received: November 13, 2014
• Last updated: July 8, 2015
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: July 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 89 Years

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma

Locations

Country	Name	City	State
United States	University of Colorado Eye Center	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No