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Oral Nutrition Impact on Tear Film

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clinicaltrials.gov/study/NCT01561040
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT015610400
Health Conditions in Trial
Dry eye syndrome
Dry eye syndrome
0
Trial Recruitment Size
800
Clinical Trial Start Date
2012
0
Primary Completion Date
2012
0
Study Completion Date
2012
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Dietary Supplement0
Interventional Trial Phase
Phase 40
Official Name
Eight Week Feasibility Study Enrolling Dry Eye Subjects Confirmed by Four of Seven Dianostic Markers Responding to Nutritional Therapy0
Last Updated
March 26, 2012
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
Omega 3, Vitamins A, D3 and E0
Study summary

Dry eye disease (DED) is a common but often inadequately treated disease of the tears and surface of the eye. It can cause poor vision and chronic pain and is more frequent with increasing age. The 1995 Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eye defined dry eye as "a disorder of the tear film due to tear deficiency or excessive evaporation, which causes damage to the interpalpebral ocular surface and is associated with symptoms of ocular discomfort". The International Dry Eye Work Shop (DEWS) committee subsequently defined dry eye as "a multi-factorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface." Typically, symptoms associated with dry eye disease include ocular burning, foreign body sensation (sand or grit), photophobia (light sensitivity), and other symptoms that result in overall long term discomfort in patients. The proposed eight week feasibility study if dry eye subjects confirmed elevated osmolarity and symptoms respond to nutritional therapy.

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