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

Alcon Research2 sites in 1 country97 target enrollmentFebruary 2008

ConditionsSjogren's Syndrome

InterventionsMaxidex No treatment

DrugsMaxidex

Overview

Phase: Phase 4
Intervention: Maxidex
Conditions: Sjogren's Syndrome
Sponsor: Alcon Research
Enrollment: 97
Locations: 2
Primary Endpoint: Change in Levels of Biomarkers After Dosing With Maxidex
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

February 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Alcon Research

Eligibility Criteria

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

Arms & Interventions

Maxidex

Intervention: Maxidex

No treatment

Healthy normal control group receiving no treatment

Intervention: No treatment

Outcomes

Primary Outcomes

Change in Levels of Biomarkers After Dosing With Maxidex

Time Frame: 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 Outcomes

Correlation Between Biomarker Expression and Ocular Symptoms(Baseline to 2 weeks)
Correlation Between Biomarker Expression and Tear Film Break up Time(Baseline to 2 weeks)
Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining(Baseline to 2 weeks)
Correlation Between Biomarker Expression and the Schirmer Test(Baseline to 2 weeks)