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

Phase 4

Completed

• Conditions: Sjogren's Syndrome
• Interventions: Other: No treatment; Drug: Maxidex

• Registration Number: NCT00631358
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-07
• Primary Completion: 2009-02
• Results First Submitted: 2010-02-17
• Status Verified: 2010-03
• Results First Submitted QC: 2010-03-29
• Last Update Submitted: 2010-03-29
• Results First Posted: 2010-04-12
• Last Update Posted: 2010-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No treatment	No treatment	Healthy normal control group receiving no treatment
Maxidex	Maxidex	Maxidex

Primary Outcome Measures

Name	Time	Method
Change in Levels of Biomarkers After Dosing With Maxidex	Baseline to 2 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Waterloo; 🇨🇦 Waterloo, Canada

Toronto; 🇨🇦 Toronto, Canada