Official Title
Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
Phase
N/ALead Sponsor
Pennsylvania State UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Dry Eye SyndromeIntervention/Treatment
icosapent ethyl ...Study Participants
27The 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.
1 gram capsule by mouth four times daily for 45 days
1 gram by mouth 4 times daily for 45 days
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)
| Event Type | Organ System | Event Term | Omega-3-acid Ethyl Esters | Corn Oil Capsule |
|---|
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)
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).
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)
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).
