Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome

Overview

The investigators hypothesize that oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline, Research Triangle Park, NC) will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (Schirmer-1 test values, positive vital staining with lissamine green, and fluorescein tear break-up time) when compared to administration of placebo.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2014

Interventions

  • Drug: Oral Omega-3-acid ethyl esters
    • 1 gram capsule by mouth four times daily for 45 days
  • Drug: Placebo corn oil capsule
    • 1 gram by mouth 4 times daily for 45 days

Arms, Groups and Cohorts

  • Active Comparator: Omega-3-acid ethyl esters
  • Placebo Comparator: Corn oil capsule

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline of the Ocular Surface Disease Index Score at Day 45
    • Time Frame: Baseline and Day 45
    • The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score – Baseline score)

Secondary Measures

  • Change From Baseline of Schirmer-1 Test Value at Day 45
    • Time Frame: Baseline and Day 45
    • Schirmer-1 Test Value is a measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Low levels of tear production are associated with dry eye. Change = (Day 45 value – Baseline value).
  • Change From Baseline of Lissamine Green Staining Score at Day 45
    • Time Frame: Baseline and Day 45
    • Lissamine Green Staining Score is a measure of ocular surface irregularity secondary to dry eye. Possible scores range from 0 (no ocular surface irregularity secondary to dry eye) to 9 (severe ocular surface irregularity secondary to dry eye). Change = (Day 45 score – Baseline score)
  • Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45
    • Time Frame: Baseline and Day 45
    • Fluorescein Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Fluorescein Tear Break-Up Time, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Day 45 value – Baseline value).

Participating in This Clinical Trial

Inclusion Criteria

  • Age > 18 years – Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking) – Schirmer Test < 8 mm/5 minutes – Fluorescein tear break-up time < 8 seconds – No current use of dry eye treatment (except artificial lubrication) – Signature on consent form Exclusion Criteria:

  • Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye – Eyelid or eyelash abnormalities – Alteration of the nasolacrimal apparatus – Treatment with drugs affecting tearing – Concomitant ocular therapies – Topical ophthalmic steroids taken during the 4 weeks before the study – Pregnant/breast-feeding women – History of liver disease – History of fish and/or shellfish allergy or hypersensitivity – History of corn allergy or hypersensitivity – Treatment with systemic anticoagulation therapy – Patients with bleeding disorders or those receiving anticoagulation (e.g., warfarin, enoxaparin, dipyridamole, clopidogrel)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Milton S. Hershey Medical Center
  • Collaborator
    • The American Society of Cataract and Refractive Surgery Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Liang, Physician – Milton S. Hershey Medical Center
  • Overall Official(s)
    • David Liang, MD, Principal Investigator, Milton S. Hershey Medical Center

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