Omega-3 Fatty Acid Supplements and Dry Eye

NCT01213342 | Terminated

• 1 other identifier: 2010H0014
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconjunctivitis Sicca

Keywords

dry eye disease

Outcome Measures

Primary Outcomes (1)

• Change in Ocular Surface Disease Index (OSDI)

  Based on previous unpublished work by our group (and others), it is suggestive that a 10 unit change in OSDI score may be clinically meaningful.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 Outcomes (3)

• Changes in Osmolarity (TearLab) value

  Baseline, 4 weeks, 12 weeks

• Changes in Staining scores

  Baseline, 4 weeks, 8 weeks

• Changes in Tear proteomics

  Baseline, 4 weeks, 8 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

This group will receive Omega-3 EFA supplements for 8 weeks. They will take 4 capsules/day.

Dietary Supplement: Omega-3 Fatty Acid

Placebo Group

PLACEBO COMPARATOR

This group will receive placebo supplements for 8 weeks. They will take 4 capsules a day.

Dietary Supplement: Soybean Soft Gels

Interventions

Omega-3 Fatty Acid DIETARY_SUPPLEMENT

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

Also known as: Fish Oil Soft Gels, ProOmega

Treatment Group

Soybean Soft Gels DIETARY_SUPPLEMENT

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%).

Also known as: Placebo Soft Gels

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ohio State University: lead
• Nordic Naturals: collaborator

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

• 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.

  PMID: 12605039 BACKGROUND

• 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.

  PMID: 12768289 BACKGROUND

• 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.

  PMID: 20031476 BACKGROUND

• 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.

  PMID: 20102404 BACKGROUND

• 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.

  PMID: 16210721 BACKGROUND

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Kelly K Nichols, OD, MPH, PhD

  The Ohio State University College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 4, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 20, 2012

Record last verified: 2012-03

Locations

US (1)