Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention

Study Overview
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Brief Summary
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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.

Conditions
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Sjogren's Syndrome

Intervention / Treatment
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* Drug: Maxidex
* Other: No treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria of Sjorgren's Population: Inclusion Criteria: 17 years or older LogMar visual acuity of 0.6 or better Ocular inflammation associated with Sjogren's Syndrome Exclusion Criteria: Has had an adverse reaction to either topical of systemic steroids in the past Has diabetes (type 1 or 2) Has glaucoma or evidence of ocular hypertension in either eye or treatment of either within six months of Visit 1 Has worn contact lenses within one week prior to Visit 1 Has received ocular prescription therapy in the last 30 days Has active ocular infections or inflammation not associated with Sjogren's Syndrome. Has any finding in the vitreous, macula, retina or choroid that show signs of inflammation and/or any structural change that in the opinion of the investigator is considered abnormal or unstable for that participant

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maxidex<br>Maxidex | Drug: Maxidex<br>* Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily<br>|
| Sham Comparator: No treatment<br>Healthy normal control group receiving no treatment | Other: No treatment<br>* Healthy normal control group receiving no treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between Biomarker Expression and Ocular Symptoms | Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index). | Baseline to 2 weeks | 
| Correlation Between Biomarker Expression and Tear Film Break up Time | Correlation factor: TNFmRNA vs. TFBUT (Tear Film Break-up Time) | Baseline to 2 weeks | 
| Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining | Correlation factor: TNFmRNA vs. NaFl staining | Baseline to 2 weeks | 
| Correlation Between Biomarker Expression and the Schirmer Test | Correlation factor: TNFmRNA vs. Schirmer | Baseline to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular inflammation