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

This study is currently recruiting participants.
Verified September 2013 by Milton S. Hershey Medical Center
Sponsor:
Collaborators:
The American Society of Cataract and Refractive Surgery Foundation
GlaxoSmithKline
Information provided by (Responsible Party):
David Liang, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01107964
First received: April 20, 2010
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Dry Eye Syndrome
Drug: Oral Omega-3-acid ethyl esters
Drug: Placebo corn oil capsule

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Treatment with systemic anticoagulation therapy
  • Patients with bleeding disorders or those receiving anticoagulation (e.g., warfarin, enoxaparin, dipyridamole, clopidogrel)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107964

Contacts
Contact: David Liang, MD (717) 531-8783 dliang@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Hershey Eye Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: David Liang, MD    717-531-8783    dliang@hmc.psu.edu   
Principal Investigator: David Liang, MD         
Sub-Investigator: Allen R Kunselman, MA         
Sponsors and Collaborators
Milton S. Hershey Medical Center
The American Society of Cataract and Refractive Surgery Foundation
GlaxoSmithKline
  More Information

No publications provided

Responsible Party: David Liang, Physician, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01107964     History of Changes
Other Study ID Numbers: 33794
Study First Received: April 20, 2010
Last Updated: September 11, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Milton S. Hershey Medical Center:
Dry Eye Syndrome
Recent Diagnosis of Dry Eye Syndrome

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on April 16, 2014