Overview

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

Status:
Completed
Trial end date:
2015-06-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborators:
GlaxoSmithKline
The American Society of Cataract and Refractive Surgery Foundation
Criteria
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)