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

February 29, 2008
March 29, 2010
February 2008
February 2009   (final data collection date for primary outcome measure)
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.
Change in levels of biomarkers after dosing with Maxidex [ Time Frame: After 2 weeks on treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00631358 on ClinicalTrials.gov Archive Site
  • 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
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 ]
Not Provided
Not Provided
 
Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sjogren's Syndrome
  • Drug: Maxidex
    Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily
  • Other: No treatment
    Healthy normal control group receiving no treatment
  • Experimental: Maxidex
    Maxidex
    Intervention: Drug: Maxidex
  • Sham Comparator: No treatment
    Healthy normal control group receiving no treatment
    Intervention: Other: No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
Not Provided
February 2009   (final data collection date for primary outcome measure)

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
Both
17 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00631358
ORE 14351
No
Ravaughn Williams, OD, MS, Alcon
Alcon Research
Not Provided
Not Provided
Alcon Research
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP