Status:
COMPLETED
Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease
Lead Sponsor:
University of Waterloo
Collaborating Sponsors:
Alcon Research
Conditions:
Sjogren's Syndrome
Dry Eye
Eligibility:
All Genders
17-70 years
Brief Summary
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....
Detailed Description
Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance and tear film instability with potential damage to the ocular surface. It...
Eligibility Criteria
Inclusion
- Inclusion criteria (Sjogren's group)
- A person is eligible for inclusion in the study, for the dry eye group, if she:
- 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).
- Has read, understood and signed an information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- 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:
- 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)
- Has read, understood and signed an information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- 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:
- Has read, understood and signed an information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Has clear corneas and no active ocular disease.
- Has had an ocular examination in the last two years.
Exclusion
- A person will be excluded from the study if he/she (Sjogren's group):
- Is a contact lens wearer.
- Has any clinically significant belpharitis.
- Has undergone corneal refractive surgery.
- Is aphakic.
- Has any active ocular disease.
- Is using any systemic or topical medications that may affect ocular health.
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- 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):
- Is a contact lens wearer.
- Has any clinically significant belpharitis.
- Has undergone corneal refractive surgery.
- Is aphakic.
- Has any active ocular disease.
- Is using any systemic or topical medications that may affect ocular health.
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- Is participating in any other type of clinical or research study.
- A person will be excluded from the study if he/she (control group):
- Has rheumatoid arthritis, diabetes, Sjogren's syndrome or any other systemic disease affecting ocular health.
- 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.
- Has undergone corneal refractive surgery.
- Is aphakic.
- Has any active ocular disease.
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
- Is participating in any other type of clinical or research study.
- Is a contact lens wearer.
- Has blepharitis.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00809003
Start Date
September 1 2007
End Date
December 1 2007
Last Update
December 16 2008
Active Locations (1)
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1
Centre for Contact Lens Research, School of Optometry
Waterloo, Ontario, Canada, N2L3G1