Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
1 other identifier
interventional
97
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 29, 2008
CompletedFirst Posted
Study publicly available on registry
March 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedResults Posted
Study results publicly available
April 12, 2010
CompletedApril 12, 2010
March 1, 2010
1 year
February 29, 2008
February 17, 2010
March 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Study Arms (2)
Maxidex
EXPERIMENTALMaxidex
No treatment
SHAM COMPARATORHealthy normal control group receiving no treatment
Interventions
Eligibility Criteria
You may qualify if:
- years or older
- LogMar visual acuity of 0.6 or better
- Ocular inflammation associated with Sjogren's Syndrome
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (2)
Toronto
Toronto, Canada
Waterloo
Waterloo, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alcon Clinical
- Organization
- Alcon Labs
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 29, 2008
First Posted
March 7, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2009
Last Updated
April 12, 2010
Results First Posted
April 12, 2010
Record last verified: 2010-03