Status:
COMPLETED
Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
Lead Sponsor:
Alcon Research
Conditions:
Sjogren's Syndrome
Eligibility:
All Genders
17+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- Inclusion Criteria of Sjorgren's Population:
- 17 years or older
- LogMar visual acuity of 0.6 or better
- Ocular inflammation associated with Sjogren's Syndrome
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00631358
Start Date
February 1 2008
Last Update
April 12 2010
Active Locations (2)
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1
Toronto
Toronto, Canada
2
Waterloo
Waterloo, Canada