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| Sponsor: | Virginia Eye Consultants |
|---|---|
| Collaborators: |
ScienceBased Health Baylor College of Medicine |
| Information provided by (Responsible Party): | Virginia Eye Consultants |
| ClinicalTrials.gov Identifier: | NCT00883649 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Keratoconjunctivitis Sicca |
Dietary Supplement: Hydroeye Other: Inactive Capsule |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 of Keratoconjunctivitis Sicca in Post-Menopausal Females |
| Enrollment: | 62 |
| Study Start Date: | September 2008 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Other: Inactive Capsule
2 Capsules BID
|
| Active Comparator: 2 |
Dietary Supplement: Hydroeye
2 Capsules BID
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Virginia Eye Consultants | |
| Norfolk, Virginia, United States, 23502 | |
| Principal Investigator: | John D Sheppard, M.D. | Virginia Eye Consultants |
| Principal Investigator: | Stephen C Pflugfelder, M.D. | Baylor College of Medicine |
| Study Chair: | Joe Wakil, M.D. | ScienceBased Health |
| Study Chair: | Penelope Edwards, MPH, CNS | ScienceBased Health |
More Information
| Responsible Party: | Virginia Eye Consultants |
| ClinicalTrials.gov Identifier: | NCT00883649 History of Changes |
| Other Study ID Numbers: | SBH2005-01 |
| Study First Received: | April 17, 2009 |
| Last Updated: | February 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Keratoconjunctivitis Sicca Dry Eyes Post-menopausal |
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases |
Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases |