Clinical trial NCT02203188: Effect of Debridement-scaling on the Relief of Dry Eye Signs and Symptoms in Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sjogren's Syndrome
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Sjogren's Society of Canada
First posted: 2014-07-29
Enrollment: 14
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with Sjogren's Syndrome often experience dry eye. Recently, a study had shown that dry eye symptoms were improved by removing debris and old skin cells along the eyelid margin. This technique is called eyelid debridement-scaling. The purpose of this study is to determine how well this technique works in improving dry eye signs and symptoms in individuals with Sjogren's Syndrome.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Meibomian gland score (MGS)
timeFrame: Baseline
measure: Meibomian gland score (MGS)
timeFrame: 1 month after baseline and/or treatment
measure: SICCA Ocular Staining Score
timeFrame: Baseline
measure: SICCA Ocular Staining Score
timeFrame: 1 month after baseline and/or treatment
measure: Ocular Surface Disease Index Score (OSDI)
timeFrame: Baseline
measure: Ocular Surface Disease Index Score (OSDI)
timeFrame: 1 month after baseline/treatment
measure: Meibomian gland yielding liquid secretions (MGYLS)
timeFrame: Baseline
measure: Meibomian gland yielding liquid secretions (MGYLS)
timeFrame: 1 month after baseline/treatment
measure: Symptom Assessment iN Dry Eye score
timeFrame: Baseline
measure: Symptom Assessment iN Dry Eye score
timeFrame: 1 month after baseline and/or treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
affiliation: CCLR, University of Waterloo
name: Lyndon Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: