Status:
TERMINATED
Omega-3 Fatty Acid Supplements and Dry Eye
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Nordic Naturals
Conditions:
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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 l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01213342
Start Date
May 1 2010
End Date
July 1 2011
Last Update
March 20 2012
Active Locations (1)
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1
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210