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

Penn State Health logo

Penn State Health

Status

Completed

Conditions

Dry Eye Syndrome

Treatments

Drug: Placebo corn oil capsule
Drug: Oral Omega-3-acid ethyl esters

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

27 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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