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Completed

NCT Number: NCT01107964

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

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.

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey Eye Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oral Omega-3-acid ethyl esters

Drug

1 gram capsule by mouth four times daily for 45 days

Placebo corn oil capsule

Drug

1 gram by mouth 4 times daily for 45 days

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • GlaxoSmithKline
  • The American Society of Cataract and Refractive Surgery Foundation

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Apr 21, 2010
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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