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

This study is currently recruiting participants.

Verified May 2012 by Penn State University

Sponsor:

Collaborators:

The American Society of Cataract and Refractive Surgery Foundation

GlaxoSmithKline

Information provided by (Responsible Party):

Ahmad A. Aref, Penn State University

ClinicalTrials.gov Identifier:

NCT01107964

First received: April 20, 2010

Last updated: May 14, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 20, 2010

Last Updated Date

May 14, 2012

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Ocular Surface Disease Index Score as a measure of subjective symptoms of dry eye [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Lissamine Green staining score as a measure of ocular surface irregularity secondary to dry eye [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]
Schirmer-1 test value (mm/5 min) as a measure of tear production [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]
Fluorescein tear break-up time (seconds) as a measure of tear film stability [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01107964 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Schirmer-1 test value (mm/5 min) as a measure of tear production [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]
Lissamine Green staining score as a measure of ocular surface irregularity secondary to dry eye [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]
Fluorescein tear break-up time (seconds) as a measure of tear film stability [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

McMonnies Dry Eye Index as a measure of subjective symptoms of dry eye [ Time Frame: 45 days post-intervention ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Dry Eye Syndrome

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Omega-3-acid ethyl esters
Intervention: Drug: Oral Omega-3-acid ethyl esters
Placebo Comparator: Corn oil capsule
Intervention: Drug: Placebo corn oil capsule

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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
Concomitant ocular pathology
History of ocular surgery
Eyelid or eyelash abnormalities
Alteration of the nasolacrimal apparatus
Treatment with drugs affecting tearing
Treatment with vitamin supplements
Concomitant ocular therapies
Topical ophthalmic steroids taken during the 4 weeks before the study
Pregnant/breast-feeding women
History of liver disease
Diabetes
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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ahmad A Aref, MD

(717) 531-8783

ahmadaref@gmail.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01107964

Other Study ID Numbers ^ICMJE

33794

Has Data Monitoring Committee

Yes

Responsible Party

Ahmad A. Aref, Penn State University

Study Sponsor ^ICMJE

Penn State University

Collaborators ^ICMJE

The American Society of Cataract and Refractive Surgery Foundation
GlaxoSmithKline

Investigators ^ICMJE

Not Provided

Information Provided By

Penn State University

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top