Status:
COMPLETED
Effect of Debridement-scaling on the Relief of Dry Eye Signs and Symptoms in Sjogren's Syndrome
Lead Sponsor:
University of Waterloo
Collaborating Sponsors:
Sjogren's Society of Canada
Conditions:
Sjogren's Syndrome
Eligibility:
All Genders
17+ years
Phase:
NA
Brief Summary
Sjogren's Syndrome is an autoimmune condition in which the body attacks its own glands in the body. Some of these glands are responsible for providing lubrication for the eye. As a result, individuals...
Eligibility Criteria
Inclusion
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is diagnosed with Sjogren's Syndrome;
- Meibomian gland score of ≤ 9 (out of 15);
- OSDI ≥ 23;
- Willing to maintain the use of OTC medications throughout the course of the study
- Have not worn contact lenses within the past 3 years
Exclusion
- Is participating in any concurrent clinical or research study;
- Has any known active\* ocular disease and/or infection;
- Has a systemic condition, other than Sjogren's Syndrome and its associated conditions, that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications, other than those indicated for Sjogren's Syndrome and its associated conditions, that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment;
- Is aphakic;
- Has undergone refractive error surgery; \* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02203188
Start Date
August 1 2014
End Date
November 1 2014
Last Update
December 19 2014
Active Locations (1)
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1
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1