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

Sjogren's Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631358
• Other study ID #: ORE 14351
• Status: Completed
• Phase: Phase 4
• First received: February 29, 2008
• Last updated: March 29, 2010
• Start date: February 2008

Study information

• Verified date: March 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Institutional Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00806702

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sjogren's Syndrome

Intervention

Drug:
• Maxidex
Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily

Other:
• No treatment
Healthy normal control group receiving no treatment

Locations

Country	Name	City	State
Canada	Toronto	Toronto
Canada	Waterloo	Waterloo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Correlation Between Biomarker Expression and Tear Film Break up Time	Correlation factor: TNFmRNA vs. TFBUT (Tear Film Break-up Time)	Baseline to 2 weeks	No
Secondary	Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining	Correlation factor: TNFmRNA vs. NaFl staining	Baseline to 2 weeks	No
Secondary	Correlation Between Biomarker Expression and the Schirmer Test	Correlation factor: TNFmRNA vs. Schirmer	Baseline to 2 weeks	No