Dry Eye Clinical Trial
— JADEOfficial title:
Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease
Verified date | December 2008 |
Source | University of Waterloo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Observational |
This project will examine the similarities and differences of the ocular surface and tear film in patients with Sjogren's syndrome related to dry eye, severe dry eye and those who do not have dry eye. This knowledge will help clinicians understand the processes that create these dry eye conditions and will strengthen the treatment and management strategies that will be used. The subjects will participate in a series of dry eye tests that they have already experienced in clinic, along with the gathering of tear samples and surface cells. These tissues will then be analyzed at a distant site.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 17 Years to 70 Years |
Eligibility |
Inclusion Criteria: Inclusion criteria (Sjogren's group) A person is eligible for inclusion in the study, for the dry eye group, if she: 1. Has been diagnosed to have SS(confirmed via American-European Consensus Criteria 2002)and dry eye and half of the time wants to use eye drops for dry eye symptoms (dry eye group). 2. Has read, understood and signed an information consent letter. 3. Is willing and able to follow instructions and maintain the appointment schedule. 4. Has had an ocular examination in the last two years. Inclusion criteria (severe DE group) A person is eligible for inclusion in the study, for the dry eye group, if he/she: 1. 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) 2. Has read, understood and signed an information consent letter. 3. Is willing and able to follow instructions and maintain the appointment schedule. 4. Has had an ocular examination in the last two years. Inclusion criteria (control group) A person is eligible for inclusion in the study, for the control group, if he/she: 1. Has read, understood and signed an information consent letter. 2. Is willing and able to follow instructions and maintain the appointment schedule. 3. Has clear corneas and no active ocular disease. 4. Has had an ocular examination in the last two years. Exclusion Criteria: A person will be excluded from the study if he/she (Sjogren's group): 1. Is a contact lens wearer. 2. Has any clinically significant belpharitis. 3. Has undergone corneal refractive surgery. 4. Is aphakic. 5. Has any active ocular disease. 6. Is using any systemic or topical medications that may affect ocular health. 7. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study. 8. Is participating in any other type of clinical or research study. A person will be excluded from the study if he/she (Dry eye group): 1. Is a contact lens wearer. 2. Has any clinically significant belpharitis. 3. Has undergone corneal refractive surgery. 4. Is aphakic. 5. Has any active ocular disease. 6. Is using any systemic or topical medications that may affect ocular health. 7. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study. 8. Is participating in any other type of clinical or research study. A person will be excluded from the study if he/she (control group): 1. Has rheumatoid arthritis, diabetes, Sjogren's syndrome or any other systemic disease affecting ocular health. 2. Is using any systemic or topical medications (other than eye drops for dry eye symptoms) that may affect ocular health and neuro-endocrine system function. 3. Has undergone corneal refractive surgery. 4. Is aphakic. 5. Has any active ocular disease. 6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study. 7. Is participating in any other type of clinical or research study. 8. Is a contact lens wearer. 9. 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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