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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alcon Research
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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