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

This study has been completed.

Sponsor:

Information provided by:

Alcon Research

ClinicalTrials.gov Identifier:

NCT00631358

First received: February 29, 2008

Last updated: March 29, 2010

Last verified: March 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	February 29, 2008
Last Updated Date	March 29, 2010
Start Date ^ICMJE	February 2008
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 29, 2010)	Change in Levels of Biomarkers After Dosing With Maxidex [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ] 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.
Original 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 ]
Change History	Complete list of historical versions of study NCT00631358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 29, 2010)	Correlation Between Biomarker Expression and Ocular Symptoms [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ] Correlation factor: tumor necrosis factor (TNF) messenger RNA (mRNA) vs. OSDI (Ocular Surface Disease Index). Correlation Between Biomarker Expression and Tear Film Break up Time [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ] Correlation factor: TNFmRNA vs. TFBUT (Tear Film Break-up Time) Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ] Correlation factor: TNFmRNA vs. NaFl staining Correlation Between Biomarker Expression and the Schirmer Test [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ] Correlation factor: TNFmRNA vs. Schirmer
Original 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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
Official Title ^ICMJE	Not Provided
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Sjogren's Syndrome
Intervention ^ICMJE	Drug: Maxidex Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily Other: No treatment Healthy normal control group receiving no treatment
Study Arm (s)	Experimental: Maxidex Maxidex Intervention: Drug: Maxidex Sham Comparator: No treatment Healthy normal control group receiving no treatment Intervention: Other: No treatment
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	97
Completion Date	Not Provided
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 Number ^ICMJE	NCT00631358
Other Study ID Numbers ^ICMJE	ORE 14351
Has Data Monitoring Committee	No
Responsible Party	Ravaughn Williams, OD, MS, Alcon
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	March 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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