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

NCT02203188 | Completed

• 1 other identifier: 20000
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• Meibomian gland yielding liquid secretions (MGYLS)

  Prior to treatment (if applicable). MGYLS is the number of glands with MGS grade 2 or higher.

  Baseline

• Meibomian gland yielding liquid secretions (MGYLS)

  MGYLS is the number of glands with MGS grade 2 or higher.

  1 month after baseline/treatment

• 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

• 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

Study Arms (2)

Lid debridgement scaling

EXPERIMENTAL

Perform lid debridgement scaling

Procedure: Lid debridgement scaling

Control

NO INTERVENTION

No Treatment

Interventions

Lid debridgement scaling PROCEDURE

Lid debridgement scaling

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Waterloo: lead
• Sjogren's Society of Canada: collaborator

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lyndon Jones, PhD

  CCLR, University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 29, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

CA (1)