Clinical Trial: Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
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.
Detailed Summary:
Sponsor: Milton S. Hershey Medical Center
Current Primary Outcome: Ocular Surface Disease Index Score as a measure of subjective symptoms of dry eye [ Time Frame: 45 days post-intervention ]
Original Primary Outcome:
- Schirmer-1 test value (mm/5 min) as a measure of tear production [ Time Frame: 45 days post-intervention ]
- Lissamine Green staining score as a measure of ocular surface irregularity secondary to dry eye [ Time Frame: 45 days post-intervention ]
- Fluorescein tear break-up time (seconds) as a measure of tear film stability [ Time Frame: 45 days post-intervention ]
Current Secondary Outcome:
- Schirmer-1 test value (mm/5 min) as a measure of tear production [ Time Frame: 45 days post-intervention ]
- Lissamine Green staining score as a measure of ocular surface irregularity secondary to dry eye [ Time Frame: 45 days post-intervention ]
- Fluorescein tear break-up time (seconds) as a measure of tear film stability [ Time Frame: 45 days post-intervention ]
Original Secondary Outcome: McMonnies Dry Eye Index as a measure of subjective symptoms of dry eye [ Time Frame: 45 days post-intervention ]
Information By: Milton S. Hershey Medical Center
Dates:
Date Received: April 20, 2010
Date Started: July 2010
Date Completion:
Last Updated: August 19, 2014
Last Verified: August 2014
