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

N/ACompletedNCT02203188

University of Waterloo14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sjogren's Syndrome

Interventions

Lid debridgement scaling

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Meibomian gland score (MGS)

Prior to treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear

Time frame: Baseline

Meibomian gland score (MGS)

Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline

Meibomian gland yielding liquid secretions (MGYLS)

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

Time frame: 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.

Time frame: 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.

Time frame: 1 month after baseline and/or treatment

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes