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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: Oral Omega-3-acid ethyl esters; Drug: Placebo corn oil capsule

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Omega-3-acid ethyl esters	Drug: Oral Omega-3-acid ethyl esters; 1 gram capsule by mouth four times daily for 45 days
PLACEBO_COMPARATOR: Corn oil capsule	Drug: Placebo corn oil capsule; 1 gram by mouth 4 times daily for 45 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: GlaxoSmithKline; The American Society of Cataract and Refractive Surgery Foundation
• Investigators: Principal Investigator: David Liang, MD, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): June 15, 2015

Study Registration Dates

• First Submitted: April 20, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (ESTIMATE): April 21, 2010

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Dry Eye Syndrome; Recent Diagnosis of Dry Eye Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 33794