Omega-3 Fatty Acid Supplements and Dry Eye

Stopped early · Not applicable · Has a placebo group

Conditions studied: Keratoconjunctivitis Sicca

In brief

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.

Key facts

Study ID

NCT01213342

Run by

Ohio State University

People needed

35

Starts

2010-05-01

Expected to finish

2011-07-01

Last updated by the study team

2012-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.