Status:
COMPLETED
The Effect of an Eyelid Warming Device for the Management of Meibomian Gland Dysfunction
Lead Sponsor:
University of Waterloo
Conditions:
Meibomian Gland Dysfunction (MGD)
Eligibility:
All Genders
17+ years
Phase:
NA
Brief Summary
Along the edge of the eyelids, there are glands (meibomian glands) that produce and deliver oils (meibum) onto the tear film. These oils serve to slow down the evaporation of tears. The meibomian glan...
Eligibility Criteria
Inclusion
- A person is eligible for inclusion in the study if he/she:
- 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;
- OSDI score ≥ 23;
- Meibomian gland score of ≤ 9 (out of 15).
- Is on a stable dry eye regimen (if applicable) within the past 4 weeks, and is willing to maintain this regimen
- Agree to using MetricWire for online data entry
- Is not a contact lens wearer (Infrequent soft contact lens wearer is acceptable (wear contact lenses for maximum 2 days of the week)).
Exclusion
- A person will be excluded from the study if he/she:
- Is participating in any concurrent clinical or research study;
- Has any known hypersensitivity to flax, linseed or any of the other constituents of the EyeBag
- Has any known active\* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications 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, as determined verbally;
- 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. An exception is made for lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02284997
Start Date
November 1 2014
End Date
April 1 2015
Last Update
May 29 2015
Active Locations (1)
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1
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1