Effect of Debridement-scaling on the Relief of Dry Eye Signs and Symptoms in Sjogren's Syndrome

Not Applicable

Completed

• Conditions: Sjogren's Syndrome
• Interventions: Procedure: Lid debridgement scaling

• Registration Number: NCT02203188
• Lead Sponsor: University of Waterloo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-29
• Study Start: 2014-08
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lid debridgement scaling	Lid debridgement scaling	Perform lid debridgement scaling

Primary Outcome Measures

Name	Time	Method
Meibomian gland score (MGS)	1 month after baseline and/or treatment	Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
SICCA Ocular Staining Score	1 month after baseline and/or treatment	Based on corneal and conjunctival staining. Total scores range 0 to 12 with 0 being no staining and 12 being high staining.
Symptom Assessment iN Dry Eye score	1 month after baseline and/or treatment	A short questionnaire based on a visual analog scale (VAS) to quantify the frequency and severity of symptoms of dry eye syndrome. The "Symptom Assessment iN Dry Eye" (SANDE) questionnaire utilizes a 100 mm horizontal VAS technique to quantify patient symptoms of ocular dryness and/or irritation.
Meibomian gland yielding liquid secretions (MGYLS)	1 month after baseline/treatment	MGYLS is the number of glands with MGS grade 2 or higher.
Ocular Surface Disease Index Score (OSDI)	1 month after baseline/treatment	The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = \[(sum of scores for all questions answered)\*100\] / \[(total number of questions answered)\*4\]. The possible range of the OSDI score is 0 to 100.

Trial Locations

Locations (1)

Centre for Contact Lens Research, University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada