The primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily
Healthy normal control group receiving no treatment
Toronto
Toronto, Canada
Waterloo
Waterloo, Canada
Change in Levels of Biomarkers After Dosing With Maxidex
Biomarkers are an indicatior of inflammation. In this study, the level of biomarkers before and after anti-inflammatory treatment (Maxidex) is measured for the treatment group. In the control group, the biomarker level is measured at baseline and 2 weeks later. ddCt (Delta-Delta-Ct) is the number of polymerase chain reaction (PCR) cycles required to generate a quantifiable number.
Time frame: Baseline to 2 weeks
Correlation Between Biomarker Expression and Ocular Symptoms
Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index).
Time frame: Baseline to 2 weeks
Correlation Between Biomarker Expression and Tear Film Break up Time
Correlation factor: TNFmRNA vs. TFBUT (Tear Film Break-up Time)
Time frame: Baseline to 2 weeks
Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining
Correlation factor: TNFmRNA vs. NaFl staining
Time frame: Baseline to 2 weeks
Correlation Between Biomarker Expression and the Schirmer Test
Correlation factor: TNFmRNA vs. Schirmer
Time frame: Baseline to 2 weeks
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