Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention
Status and phase
Completed
Phase 4
Conditions
Sjogren's Syndrome
Treatments
Drug: Maxidex
Other: No treatment
Details and patient eligibility
About
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.
Enrollment
97 patients
Sex
All
Ages
17+ years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
97 participants in 2 patient groups
Maxidex
Experimental group
Description:
Maxidex
Treatment:
Drug: Maxidex
No treatment
Sham Comparator group
Description:
Healthy normal control group receiving no treatment
Treatment:
Other: No treatment
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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