Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome

Inclusion criteria

Subjects must fulfill the following conditions to qualify for enrollment into the trial

• Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years.
• History of using or desiring artificial tears for DED symptoms within the past 2 months.
• Unanesthetized Schirmer's Test (UA ST) score ≥1 and < 10 mm/5 min and baseline total Corneal Fluorescein Staining (tCFS) score ≥2 and ≤ 15 (National Eye Institute, NEI, grading scale).

Exclusion criteria

Subjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.

• History of ocular surgery within the past 6 months.
• Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study
• On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period.
• Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period.
• Use of artificial tears within 2 hours prior to the baseline or study visit days.
• Any known allergies to any component of the study drug.
• Severe, uncontrolled autoimmune disease (e.g., rheumatoid arthritis, lupus). Uncontrolled is at the discretion of the PI. Subjects with severe systemic symptoms will not be included.