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

Sjogren's Syndrome Clinical Trial

— TOYOTA  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203188
• Other study ID #: 20000
• Status: Completed
• Phase: N/A
• First received: July 25, 2014
• Last updated: December 18, 2014
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: December 2014
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Clinical Research Ethics CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sjogren's Syndrome

Intervention

Procedure:
• Lid debridgement scaling

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Sjogren's Society of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meibomian gland score (MGS)	Prior to treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear	Baseline	No
Primary	Meibomian gland score (MGS)	Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear	1 month after baseline and/or treatment	No
Primary	SICCA Ocular Staining Score	Prior to treatment (if applicable). Based on corneal and conjunctival staining. Total scores range 0 to 12 with 0 being no staining and 12 being high staining.	Baseline	No
Primary	SICCA Ocular Staining Score	Based on corneal and conjunctival staining. Total scores range 0 to 12 with 0 being no staining and 12 being high staining.	1 month after baseline and/or treatment	No
Primary	Ocular Surface Disease Index Score (OSDI)	Prior to treatment (if applicable). 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.	Baseline	No
Primary	Ocular Surface Disease Index Score (OSDI)	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.	1 month after baseline/treatment	No
Primary	Meibomian gland yielding liquid secretions (MGYLS)	Prior to treatment (if applicable). MGYLS is the number of glands with MGS grade 2 or higher.	Baseline	No
Primary	Meibomian gland yielding liquid secretions (MGYLS)	MGYLS is the number of glands with MGS grade 2 or higher.	1 month after baseline/treatment	No
Primary	Symptom Assessment iN Dry Eye score	Prior to treatment (if applicable). 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.	Baseline	No
Primary	Symptom Assessment iN Dry Eye score	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.	1 month after baseline and/or treatment	No