We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01107964
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
Study Start Date : July 2010
Primary Completion Date : August 2014
Study Completion Date : June 15, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline of the Ocular Surface Disease Index Score at Day 45 [ Time Frame: Baseline and 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)


Secondary Outcome Measures :
  1. Change From Baseline of Schirmer-1 Test Value at Day 45 [ Time Frame: Baseline and 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).

  2. Change From Baseline of Lissamine Green Staining Score at Day 45 [ Time Frame: Baseline and 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)

  3. Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45 [ Time Frame: Baseline and 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).



Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: David Liang, MD Milton S. Hershey Medical Center
More Information

Responsible Party: David Liang, Physician, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01107964     History of Changes
Other Study ID Numbers: 33794
First Posted: April 21, 2010    Key Record Dates
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017
Last Verified: November 2017

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

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