Omega-3 Fatty Acid Supplements and Dry Eye

Keratoconjunctivitis Sicca Clinical Trial

Official title:

Omega-3 Fatty Acid Supplementation and Dry Eye

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01213342
• Other study ID #: 2010H0014
• Status: Terminated
• Phase: N/A
• First received: September 30, 2010
• Last updated: March 19, 2012
• Start date: May 2010
• Est. completion date: July 2011

Study information

• Verified date: March 2012
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01131338

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

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
• 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%).

Locations

Country	Name	City	State
United States	The Ohio State University College of Optometry	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Nordic Naturals

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Macrì 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):561-6. Epub 2003 May 27. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in Osmolarity (TearLab) value	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	No
Secondary	Changes in Staining scores	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	No
Secondary	Changes in Tear proteomics	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	No