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Omega-3 Fatty Acid Supplements and Dry Eye

Primary Purpose

Keratoconjunctivitis Sicca

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty Acid
Soybean Soft Gels
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca focused on measuring dry eye disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ohio State University College of Optometry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Placebo Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Changes in Staining scores
Changes in average staining scores (average of 5 corneal regions; 6 conjunctival regions) and sum staining scores will be evaluated.
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.

Full Information

First Posted
September 30, 2010
Last Updated
March 19, 2012
Sponsor
Ohio State University
Collaborators
Nordic Naturals
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1. Study Identification

Unique Protocol Identification Number
NCT01213342
Brief Title
Omega-3 Fatty Acid Supplements and Dry Eye
Official Title
Omega-3 Fatty Acid Supplementation and Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Researchers left institution
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ohio State University
Collaborators
Nordic Naturals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca
Keywords
dry eye disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
This group will receive Omega-3 EFA supplements for 8 weeks. They will take 4 capsules/day.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
This group will receive placebo supplements for 8 weeks. They will take 4 capsules a day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Fatty Acid
Other Intervention Name(s)
Fish Oil Soft Gels, ProOmega
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Soybean Soft Gels
Other Intervention Name(s)
Placebo Soft Gels
Intervention Description
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%).
Primary Outcome Measure Information:
Title
Change in Ocular Surface Disease Index (OSDI)
Description
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.
Time Frame
Baseline, 4 weeks into treatment, 8 weeks into treatment
Secondary Outcome Measure Information:
Title
Changes in Osmolarity (TearLab) value
Description
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.
Time Frame
Baseline, 4 weeks, 12 weeks
Title
Changes in Staining scores
Description
Changes in average staining scores (average of 5 corneal regions; 6 conjunctival regions) and sum staining scores will be evaluated.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Changes in Tear proteomics
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly K Nichols, OD, MPH, PhD
Organizational Affiliation
The Ohio State University College of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12605039
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.
Results Reference
background
PubMed Identifier
12768289
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.
Results Reference
background
PubMed Identifier
20031476
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.
Results Reference
background
PubMed Identifier
20102404
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.
Results Reference
background
PubMed Identifier
16210721
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.
Results Reference
background

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Omega-3 Fatty Acid Supplements and Dry Eye

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