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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01107964
• Other study ID #: 33794
• Status: Completed
• Phase: N/A
• First received: April 20, 2010
• Last updated: November 29, 2017
• Start date: July 2010
• Est. completion date: June 15, 2015

Study information

• Verified date: November 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 15, 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• Oral Omega-3-acid ethyl esters
1 gram capsule by mouth four times daily for 45 days
• Placebo corn oil capsule
1 gram by mouth 4 times daily for 45 days

Locations

Country	Name	City	State
United States	Penn State Hershey Eye Center	Hershey	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	GlaxoSmithKline, The American Society of Cataract and Refractive Surgery Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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