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

Not Applicable

Completed

Interventions: Drug: Placebo corn oil capsule
Drug: Oral Omega-3-acid ethyl esters

Brief Summary: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Corn oil capsule	Placebo corn oil capsule	-
Omega-3-acid ethyl esters	Oral Omega-3-acid ethyl esters	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline of the Ocular Surface Disease Index Score at Day 45	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 Outcome Measures

Name	Time	Method
Change From Baseline of Schirmer-1 Test Value at Day 45	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	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	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).