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Omega-3 Fatty Acid Supplements and Dry Eye

NCT01213342 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2012-03-20

No results posted yet for this study

Summary

Omega-3 fatty acids have been associated with a decline in inflammation. As dry eye disease is associated with inflammation of the ocular surface (DEWS report, Ocular Surface, 2007), the investigators hypothesize that the omega-3 fatty acid supplements used in this study will help to improve dry eye signs, such as eye surface irritation (staining) and tear film osmolarity, which is an overall measure of tear film stability and dry eye status. Further, the investigators hypothesize that dry eye symptoms, the end result of dry eye disease, such as discomfort and burning, will also improve with supplementation.

Conditions

  • Keratoconjunctivitis Sicca

Interventions

DIETARY_SUPPLEMENT

Omega-3 Fatty Acid

Each patient will be instructed to take 4 soft gel capsules per day (2 with the morning meal and 2 with the evening meal). They will continue this regimen for 8 weeks. The total daily amount included in 4 soft gels includes: * EPA (Eicosapentaenoic Acid) 1300mg * DHA (Docosahexaenoic Acid) 900 mg * Other Omega-3's 360mg * Total Omega 3's 2560 mg

DIETARY_SUPPLEMENT

Soybean Soft Gels

Each patient will be instructed to take 4 soft gel capsules per day (2 with the morning meal and 2 with the evening meal. The main ingredient in the placebos is soybean oil (95.6%).

Sponsors & Collaborators

  • Nordic Naturals

    collaborator INDUSTRY

  • Ohio State University

    lead OTHER

Principal Investigators

  • Kelly K Nichols, OD, MPH, PhD · The Ohio State University College of Optometry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213342 on ClinicalTrials.gov