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Tivanisiran for Dry Eye in Subjects with Sjogren's Syndrome

Study

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Description

The purpose of this study is to compare the safety and effectiveness of tivanisiran sodium ophthalmic solution (eye drops) to placebo for treating signs and symptoms of DED in participants with a documented diagnosis of dry eye associated with Sjögren’s Syndrome.

Main Procedures Involved: 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

Duration of Participation: 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

18 to 100 years

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

Compensation

Compensation Provided

Location

University of Colorado Hospital

Principal Investigator
Scott Hauswirth,  OD

Scott Hauswirth, OD

Resources

Study ID

Protocol Number: 21-2624

More information available at ClinicalTrials.gov: NCT04819269

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