Clinical trial NCT01213342: Omega-3 Fatty Acid Supplements and Dry Eye
Official title: Omega-3 Fatty Acid Supplementation and Dry Eye
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Keratoconjunctivitis Sicca
Keywords: dry eye disease
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Nordic Naturals
First posted: 2010-10-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Ocular Surface Disease Index (OSDI)
timeFrame: Baseline, 4 weeks into treatment, 8 weeks into treatment
Secondary outcomes:
measure: Changes in Osmolarity (TearLab) value
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Changes in Staining scores
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Changes in Tear proteomics
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
affiliation: The Ohio State University College of Optometry
name: Kelly K Nichols, OD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barabino S, Rolando M, Camicione P, Ravera G, Zanardi S, Giuffrida S, Calabria G. Systemic linoleic and gamma-linolenic acid therapy in dry eye syndrome with an inflammatory component. Cornea. 2003 Mar;22(2):97-101. doi: 10.1097/00003226-200303000-00002.
citation: Macri A, Giuffrida S, Amico V, Iester M, Traverso CE. Effect of linoleic acid and gamma-linolenic acid on tear production, tear clearance and on the ocular surface after photorefractive keratectomy. Graefes Arch Clin Exp Ophthalmol. 2003 Jul;241(7):561-566. doi: 10.1007/s00417-003-0685-x. Epub 2003 May 27.
citation: Roncone M, Bartlett H, Eperjesi F. Essential fatty acids for dry eye: A review. Cont Lens Anterior Eye. 2010 Apr;33(2):49-54; quiz 100. doi: 10.1016/j.clae.2009.11.002. Epub 2009 Dec 23.
citation: Massi D, Franchi A, Alos L, Cook M, Di Palma S, Enguita AB, Ferrara G, Kazakov DV, Mentzel T, Michal M, Panelos J, Rodriguez-Peralto JL, Santucci M, Tragni G, Zioga A, Dei Tos AP. Primary cutaneous leiomyosarcoma: clinicopathological analysis of 36 cases. Histopathology. 2010 Jan;56(2):251-62. doi: 10.1111/j.1365-2559.2009.03471.x.
citation: Miljanovic B, Trivedi KA, Dana MR, Gilbard JP, Buring JE, Schaumberg DA. Relation between dietary n-3 and n-6 fatty acids and clinically diagnosed dry eye syndrome in women. Am J Clin Nutr. 2005 Oct;82(4):887-93. doi: 10.1093/ajcn/82.4.887.