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

This study has been completed.
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: August 19, 2014
Last verified: August 2014
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107964

Locations
United States, Pennsylvania
Penn State Hershey Eye Center
Hershey, Pennsylvania, United States, 17033
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: August 19, 2014
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 August 20, 2014