Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
50 Years
N/A
Both
Dry Eye Disease
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:
Interventional
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:
No
Authority:
United States: Institutional Review Board
Study ID:
2012P001332
NCT ID:
NCT01880463
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
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