Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Placebo corn oil capsule
- Conditions
- Dry Eye Syndrome
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Change From Baseline of the Ocular Surface Disease Index Score at Day 45
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
David Liang
Physician
Milton S. Hershey Medical Center
Eligibility 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
Arms & Interventions
Corn oil capsule
Intervention: Placebo corn oil capsule
Omega-3-acid ethyl esters
Intervention: Oral Omega-3-acid ethyl esters
Outcomes
Primary Outcomes
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 Outcomes
- Change From Baseline of Schirmer-1 Test Value at Day 45(Baseline and Day 45)
- Change From Baseline of Lissamine Green Staining Score at Day 45(Baseline and Day 45)
- Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45(Baseline and Day 45)