Clinical Trial: Efficacy and Safety Study of Nutritional Supplements for Treatments of Dry Eye
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Parallel-Group, Placebo-Control, Double-Blind Trial Comparing the Efficacy and Safety of Nutritional Supplementation Containing Omega 3 Fatty Acids and Gamma Linoleic Acid, for Treatment
Brief Summary: The purpose of this study is to determine the effectiveness of a nutritional supplement in post-menopausal women age 40 or older with moderate to severe dry eyes. This study is being conducted to determine if signs and symptoms of dry eye will improve with the use of this nutritional supplement.
Detailed Summary:
Sponsor: Virginia Eye Consultants
Current Primary Outcome:
- Schirmer tear test [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
- Ocular Surface Disease Index [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
- Tear Breakup Time [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
- Corneal Staining with Fluorescein [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
- Impression Cytology [ Time Frame: Screening, Week 12, Week 24 ]
- Conjunctival staining with lissamine [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Corneal Topography [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
- Meibomian Gland Dysfunction [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
- Facial Expression Subjective Scale [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
- Frequency of Artificial Tear Usage [ Time Frame: Screening, Week 4, Week 12, Week 24 ]
- HLA-DR Staining of Impression Cytology [ Time Frame: Screening, Week 12, Week 24 ]
Original Secondary Outcome: Same as current
Information By: Virginia Eye Consultants
Dates:
Date Received: April 17, 2009
Date Started: September 2008
Date Completion:
Last Updated: February 16, 2012
Last Verified: February 2012
