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

• ClinicalTrials.gov Identifier: NCT02203188
• Recruitment Status: Completed
• First Posted: July 29, 2014
• Last Update Posted: December 19, 2014
• Sponsor: University of Waterloo
• Collaborator: Sjogren's Society of Canada
• Information provided by (Responsible Party): University of Waterloo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sjogren's Syndrome	Procedure: Lid debridgement scaling	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: August 2014
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lid debridgement scaling; Perform lid debridgement scaling	Procedure: Lid debridgement scaling
No Intervention: Control; No Treatment

Outcome Measures

Primary Outcome Measures :

1. Meibomian gland score (MGS) [ Time Frame: Baseline ]
   Prior to treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
2. Meibomian gland score (MGS) [ Time Frame: 1 month after baseline and/or treatment ]
   Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
3. SICCA Ocular Staining Score [ Time Frame: Baseline ]
   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.
4. SICCA Ocular Staining Score [ Time Frame: 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.
5. Ocular Surface Disease Index Score (OSDI) [ Time Frame: Baseline ]
   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.
6. Ocular Surface Disease Index Score (OSDI) [ Time Frame: 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.
7. Meibomian gland yielding liquid secretions (MGYLS) [ Time Frame: Baseline ]
   Prior to treatment (if applicable). MGYLS is the number of glands with MGS grade 2 or higher.
8. Meibomian gland yielding liquid secretions (MGYLS) [ Time Frame: 1 month after baseline/treatment ]
   MGYLS is the number of glands with MGS grade 2 or higher.
9. Symptom Assessment iN Dry Eye score [ Time Frame: Baseline ]
   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.
10. Symptom Assessment iN Dry Eye score [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 17 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Canada, Ontario

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada, N2L 3G1

Sponsors and Collaborators

University of Waterloo

Sjogren's Society of Canada

Investigators

• Principal Investigator: Lyndon Jones, PhD; CCLR, University of Waterloo

More Information

• Responsible Party: University of Waterloo
• ClinicalTrials.gov Identifier: NCT02203188
• Other Study ID Numbers: 20000
• First Posted: July 29, 2014
• Last Update Posted: December 19, 2014
• Last Verified: December 2014

Additional relevant MeSH terms:

Sjogren's Syndrome; Syndrome; Disease; Pathologic Processes; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases