Tivanisiran for Dry Eye in Subjects with Sjogren's Syndrome

This Study is
No Longer Enrolling

Description

Eye exam in both eyes and medical, ocular and surgical history review. Blood draw for eligibility including Sjogren's assessment (SSA, SSB) within 6 weeks prior to the Visit 1 and safety laboratory tests Study Duration: Approximately 3.5 to 4.5 months (includes a possible 6-week washout, a 14-day Run-In phase + 85-day double-masked active or vehicle treatment phase) total of 5 in-clinic visits.

Details
Age

Adult

Eligibility

Male or a female age18 years or older. Use of artificial tears, autologous serum tears or specific dry eye medications during the last 6 months. Diagnosed with either primary or secondary Sjogrens Syndrome as defined by the following (MUST BE CONFIRMED PRIOR TO RUN-IN) Seropositive for anti-Ro/SSA and/or anti-La/SSB antibodies AND/OR Positive salivary gland biopsy.

Type of Study

Treatment

Locations

University of Colorado Hospital

Study ID

Protocol Number: 21-2624

More information available at ClinicalTrials.gov: NCT04819269

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