Omega-3 Fatty Acid Supplements and Dry Eye

March 19, 2012 updated by: Ohio State University

Omega-3 Fatty Acid Supplementation and Dry Eye

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Dry Eye is a disorder of the tear film due to tear deficiency or excessive tear evaporation which causes damage to the exposed ocular surface and is associated with symptoms of ocular discomfort. If left untreated, severe dry eyes can lead to desiccation of the corneal epithelium, increased discomfort and sometimes loss of vision. Abundant evidence from animal models and clinical evaluations confirm that inflammation is an integral part of all moderate and severe Dry Eye Disease (DED) states and is likely to be significant in the pathogenesis leading to the chronicity of DED. Omega-3 essential fatty acids (EFAs) have been shown to have anti-inflammatory effects and inhibit multiple aspects of inflammatory response.

DED is a common and growing problem as our population ages, causing chronic pain and visual disturbance that is not adequately treated with current approaches. If left untreated, severe dry eyes can lead to desiccation of the corneal epithelium, increased discomfort and sometimes loss of vision.The benefits are the possibility of alleviating or eliminating these symptoms of DED and the clinical data that will be gained on the safety and efficacy of omega-3s, which are already being marketed over-the-counter for the treatment of DED without any hard scientific data. The potential benefits of treatment outweigh the minimal risk of participation.

This study hopes to discover more about the efficacy and tolerability of omega-3 EFA's in the treatment of dry eye and ocular surface disease.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Each qualified participant will have an eye doctor's diagnosis of dry eye disease.
  • Answers to both questions: "How often do your eyes feel dry, how often do your eyes feel irritated" will either be "Often or Constant." (Schaumberg)
  • ≥ 18 years of age
  • The current use of artificial tears at least one time per week.
  • Be willing/able to return for all study visits and to follow instructions from the study investigator and his/her staff.
  • Stable dosage for one month time of all ocular medications and systemic medications (includes Restasis).
  • Be able to swallow large, soft gels.

Exclusion Criteria:

  • Patients who are allergic to ingredients of the treatment or placebo soft gels (fish, soybean oil, citrus).
  • Current diagnosis of ocular infection (e.g. bacterial, viral or fungal).
  • History of ocular herpetic keratitis.
  • Past or current history of liver disease.
  • Current use of blood thinners.
  • Eye surgery (including cataract surgery) within 6 months prior to randomization.
  • Previous LASIK surgery.
  • Pregnant or nursing/lactating.
  • Participation in a study of an investigational drug or device within the past 30 days.
  • Cognitive or psychiatric deficit that precludes informed consent or ability to perform requirements of the investigation.
  • Changes in ocular or systemic medications in the past 30 days.
  • Contact lens wearers.
  • Glaucoma diagnosis and/or use of glaucoma medications.
  • Current use of punctual plugs.
  • Current use of EPA/DHA supplements in excess of 1 gram/day.
  • Use of ocular steroids currently or in the past 7 days.
  • Patients planning on changing dosage of eye medications during the study.
  • Patients who have an allergy to fluorescein.
  • Patients who take aspirin daily.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
This group will receive Omega-3 EFA supplements for 8 weeks. They will take 4 capsules/day.
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
Other Names:
  • Fish Oil Soft Gels
  • ProOmega
Placebo Comparator: Placebo Group
This group will receive placebo supplements for 8 weeks. They will take 4 capsules a day.
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%).
Other Names:
  • Placebo Soft Gels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Ocular Surface Disease Index (OSDI)
Time Frame: Baseline, 4 weeks into treatment, 8 weeks into treatment
Based on previous unpublished work by our group (and others), it is suggestive that a 10 unit change in OSDI score may be clinically meaningful. There currently is no accepted survey instrument to monitor change in DED clinical trials, although the OSDI has wide acceptance clinically. This study will help define what unit of change may be clinically and statistically acceptable for future trials.
Baseline, 4 weeks into treatment, 8 weeks into treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Osmolarity (TearLab) value
Time Frame: Baseline, 4 weeks, 12 weeks
The TearLab also has limited use in DED clinical trials. Our best estimate of a clinically meaningful change is 7 mOsm/kg (reported dry eye, 315mOsm/kg - reported normal, 308 mOsm/kg). Again, as this has never been assessed, these results here are pilot in nature.
Baseline, 4 weeks, 12 weeks
Changes in Staining scores
Time Frame: Baseline, 4 weeks, 8 weeks
Changes in average staining scores (average of 5 corneal regions; 6 conjunctival regions) and sum staining scores will be evaluated.
Baseline, 4 weeks, 8 weeks
Changes in Tear proteomics
Time Frame: Baseline, 4 weeks, 8 weeks
This portion of the study is exploratory in nature. iTRAQ proteomics using mass spectrometry and RayBiotech quantibody microarrays will be used evaluate changes in inflammatory mediators for future biomarker search and pathway analysis.
Baseline, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

Nordic Naturals

Investigators

  • Principal Investigator: Kelly K Nichols, OD, MPH, PhD, The Ohio State University College of Optometry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

September 30, 2010

First Posted (Estimate)

October 4, 2010

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010H0014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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