Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention (JADE2)

This study has been completed.

First Received: February 29, 2008 Last Updated: October 2, 2009 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00631358

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: 0.1% Dexamethasone (Maxidex)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment

Resource links provided by NLM:

MedlinePlus related topics: Sjogren's Syndrome

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

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: After 2 weeks on treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	90
Study Start Date:	February 2008
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention No treatment
2: Active Comparator Treatment with Maxidex	Drug: 0.1% Dexamethasone (Maxidex) Anti-inflammatory Agent

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
Waterloo
Waterloo, Canada
Toronto
Toronto, Canada

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon ( Ravaughn Williams, OD, MS )
Study ID Numbers:	ORE 14351
Study First Received:	February 29, 2008
Last Updated:	October 2, 2009
ClinicalTrials.gov Identifier:	NCT00631358 History of Changes
Health Authority:	Canada: Health Canada; Canada: Institutional Ethics Committee

Keywords provided by Alcon Research:

Ocular inflammation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Mouth Diseases
Dexamethasone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Arthritis, Rheumatoid
Lacrimal Apparatus Diseases
Antiemetics
Dry Eye Syndromes
Hormones
Pathologic Processes
Musculoskeletal Diseases
Therapeutic Uses
Arthritis

Syndrome
Connective Tissue Diseases
Salivary Gland Diseases
Disease
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Joint Diseases
Eye Diseases
Gastrointestinal Agents
Rheumatic Diseases
Glucocorticoids
Xerostomia
Pharmacologic Actions
Autonomic Agents

ClinicalTrials.gov processed this record on November 27, 2009