Dry Eye Clinical Trial
— GARNETOfficial title:
Biochemical Factors for a Dry Eyed Population
Verified date | February 2009 |
Source | University of Waterloo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Observational |
The purpose of this study is to compare various symptoms and signs of dry-eye as well as stratify characteristics of the tear film in a group of dry-eyed individuals in comparison to a group of non-dry-eyed people. Dry-eye is a condition that significantly impacts the quality of life of the sufferer. These are people who are predominantly female and in the older age groups. Determining what characterises a person with dry-eyes is of importance to understanding the disease process.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 75 Years |
Eligibility |
Inclusion Criteria: A person is eligible for inclusion in the study, for the dry eye group or control, if she: 1. Is Caucasian, and has full legal capacity to volunteer. 2. Is post-menopausal, with menses ceasing more than 12 months ago. 3. Has moderate or severe dry eye symptoms based on dry eye questionnaire and half of the time wants to use eye drops for dry eye symptoms (dry eye group) 4. Has read, understood and signed an information consent letter. 5. Is willing and able to follow instructions and maintain the appointment schedule. 6. Has clear corneas and no active ocular disease. 7. Has had an ocular examination in the last two years. Exclusion Criteria: 1. Is on hormone replacement therapy (HRT). 2. Ceased menses due to autoimmune disorders, mumps, chemotherapy, pelvic irradiation or smoking. 3. Has rheumatoid arthritis, diabetes, Sjogren's syndrome or any other systemic disease affecting ocular health. 4. Is using any systemic or topical medications (other than eye drops for dry eye symptoms) that may affect ocular health and neuroendocrine system function. 5. Has undergone corneal refractive surgery. 6. Is aphakic. 7. Has any active ocular disease. 8. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study. 9. Is participating in any other type of clinical or research study. 10. Is a contact lens wearer. 11. Has blepharitis. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Contact Lens Research, School of Optometry | Waterloo | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Waterloo | Alcon Research |
Canada,
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