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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00631358
First Posted: March 7, 2008
Last Update Posted: April 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  Purpose
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.

Condition Intervention Phase
Sjogren's Syndrome Drug: Maxidex Other: No treatment Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in Levels of Biomarkers After Dosing With Maxidex [ Time Frame: Baseline to 2 weeks ]
    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.


Secondary Outcome Measures:
  • Correlation Between Biomarker Expression and Ocular Symptoms [ Time Frame: Baseline to 2 weeks ]
    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 ]

    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 ]

    Correlation factor:

    TNFmRNA vs. NaFl staining


  • Correlation Between Biomarker Expression and the Schirmer Test [ Time Frame: Baseline to 2 weeks ]
    Correlation factor: TNFmRNA vs. Schirmer


Enrollment: 97
Study Start Date: February 2008
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maxidex
Maxidex
Drug: Maxidex
Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily
Sham Comparator: No treatment
Healthy normal control group receiving no treatment
Other: No treatment
Healthy normal control group receiving no treatment

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631358


Locations
Canada
Toronto
Toronto, Canada
Waterloo
Waterloo, Canada
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Ravaughn Williams, OD, MS, Alcon
ClinicalTrials.gov Identifier: NCT00631358     History of Changes
Obsolete Identifiers: NCT00806702
Other Study ID Numbers: ORE 14351
First Submitted: February 29, 2008
First Posted: March 7, 2008
Results First Submitted: February 17, 2010
Results First Posted: April 12, 2010
Last Update Posted: April 12, 2010
Last Verified: March 2010

Keywords provided by Alcon Research:
Ocular inflammation

Additional relevant MeSH terms:
Sjogren's Syndrome
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents