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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: Oral Omega-3-acid ethyl esters
* Drug: Placebo corn oil capsule


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3-acid ethyl esters<br> | Drug: Oral Omega-3-acid ethyl esters<br>* 1 gram capsule by mouth four times daily for 45 days<br>|
| Placebo Comparator: Corn oil capsule<br> | Drug: Placebo corn oil capsule<br>* 1 gram by mouth 4 times daily for 45 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline of the Ocular Surface Disease Index Score at 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) | Baseline and Day 45 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline of Schirmer-1 Test Value at 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). | Baseline and Day 45 | 
| Change From Baseline of Lissamine Green Staining Score at 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) | Baseline and Day 45 | 
| Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at 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). | Baseline and Day 45 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndrome, Recent Diagnosis of Dry Eye Syndrome