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

March 29, 2010 updated by: Alcon Research
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada
        • Toronto
      • Waterloo, Canada
        • Waterloo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Biomarker Expression and Ocular Symptoms
Time Frame: Baseline to 2 weeks
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
Time Frame: Baseline to 2 weeks

Correlation factor:

TNFmRNA vs. TFBUT (Tear Film Break-up Time)
Baseline to 2 weeks
Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining
Time Frame: Baseline to 2 weeks

Correlation factor:

TNFmRNA vs. NaFl staining
Baseline to 2 weeks
Correlation Between Biomarker Expression and the Schirmer Test
Time Frame: Baseline to 2 weeks
Correlation factor: TNFmRNA vs. Schirmer
Baseline to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

February 29, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

April 12, 2010

Last Update Submitted That Met QC Criteria

March 29, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORE 14351

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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