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OpenTrials
Completed

NCT Number: NCT00631358

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

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.

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Key information

Conditions

Sjogren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Toronto, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maxidex

Drug

Maxidex (0.1% Dexamethasone) 1 drop in each eye 2 times daily

No treatment

Other

Healthy normal control group receiving no treatment

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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)

  3. Correlation Between Biomarker Expression and NaFl (Sodium Fluorescein) Staining

    Time frame: Baseline to 2 weeks

    Correlation factor:

    TNFmRNA vs. NaFl staining

  4. Correlation Between Biomarker Expression and the Schirmer Test

    Time frame: Baseline to 2 weeks

    Correlation factor: TNFmRNA vs. Schirmer

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
First posted
Mar 7, 2008
Registry last updated
Apr 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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