Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention (JADE2) - Tabular View

Tracking Information
First Received Date ^ICMJE	February 29, 2008
Last Updated Date	October 2, 2009
Start Date ^ICMJE	February 2008
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 29, 2008)	Change in levels of biomarkers after dosing with Maxidex [ Time Frame: After 2 weeks on treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00631358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 29, 2008)	Correlation between biomarker expression, and corneal staining, tear film break up time and ocular symptoms [ Time Frame: After 2 weeks of treatment ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention (JADE2)
Official Title ^ICMJE
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
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Single Group Assignment
Condition ^ICMJE	Sjogren's Syndrome
Intervention ^ICMJE	Drug: 0.1% Dexamethasone (Maxidex)
Study Arms / Comparison Groups	No Intervention: No treatment Active Comparator: Treatment with Maxidex
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	90
Completion Date
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	17 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT ID ^ICMJE	NCT00631358
Responsible Party	Ravaughn Williams, OD, MS, Alcon
Study ID Numbers ^ICMJE	ORE 14351
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Alcon Research
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP