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Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)

50 Years
Open (Enrolling by invite only)
Dry Eye Disease

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Trial Information

Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)

This ancillary study to VITAL will examine the efficacy of omega-3 fatty acids and vitamin
D3 in prevention of dry eye disease. The primary aims are to test whether omega-3 fatty acid
supplementation (1) reduces the incidence of dry eye disease, and (2) improves the natural
history of dry eye disease by relieving symptoms and other impacts on quality of life.
Secondary aims are to estimate the incidence of dry eye disease in the US, prospectively
examine the natural history of dry disease, explore factors that could modify or influence
the impact of omega-3 fatty acid supplementation, evaluate the interrelationship of dry eye
disease and depression, and test for possible independent or joint effects of vitamin D3
supplementation in the incidence and natural history of dry eye disease.

Inclusion Criteria:

- All participants in VITAL (NCT 01169259) are eligible to participate in this
ancillary study.

Exclusion Criteria:

- None

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Dry Eye Disease

Outcome Description:

Report of a diagnosis of dry eye disease confirmed by medical record review.

Outcome Time Frame:

5 years

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

June 2016

Related Keywords:

  • Dry Eye Disease
  • Dry eye disease
  • incidence
  • progression
  • Keratoconjunctivitis Sicca
  • Dry Eye Syndromes
  • Eye Diseases