Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
NCT ID: NCT01107964
Last Updated: 2017-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2010-07-31
2015-06-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Omega-3-acid ethyl esters
Oral Omega-3-acid ethyl esters
1 gram capsule by mouth four times daily for 45 days
Corn oil capsule
Placebo corn oil capsule
1 gram by mouth 4 times daily for 45 days
Interventions
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Oral Omega-3-acid ethyl esters
1 gram capsule by mouth four times daily for 45 days
Placebo corn oil capsule
1 gram by mouth 4 times daily for 45 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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The American Society of Cataract and Refractive Surgery Foundation
OTHER
GlaxoSmithKline
INDUSTRY
Milton S. Hershey Medical Center
OTHER
Responsible Party
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David Liang
Physician
Principal Investigators
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David Liang, MD
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Penn State Hershey Eye Center
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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33794
Identifier Type: -
Identifier Source: org_study_id