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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:
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
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ 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.


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631358

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

No publications provided

Responsible Party: Ravaughn Williams, OD, MS, Alcon
ClinicalTrials.gov Identifier: NCT00631358     History of Changes
Obsolete Identifiers: NCT00806702
Other Study ID Numbers: ORE 14351
Study First Received: February 29, 2008
Results First Received: February 17, 2010
Last Updated: March 29, 2010
Health Authority: Canada: Health Canada
Canada: Institutional Ethics Committee

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
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on June 17, 2013