NCT03408015

Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Every night during sleep, there is an accumulation of white blood cells in the closed eye. The closed eye white blood cells are predominantly neutrophils, but there is a small population (3%) of T cells. The effects of these closed eye white blood cells on dry eye disease pathogenesis have yet to be fully elucidated, but preliminary evidence suggests that closed eye neutrophils may have an associated hyperactivity and increased degranulation in dry eye disease that could contribute to epithelial instability. As an anti-T cell therapy, Xiidra offers an opportunity to better understand how the closed eye white blood cells are recruited and activated. This study also seeks to verify the proposed mechanism of action.

Conditions

• Ocular Discomfort
• Ocular Inflammation
• Dry Eye
• Contact Lens Complication
• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DRUG	Lifitegrast	Lifitegrast ophthalmic solution, 5.0%. 1 drop instilled into each eye once in the morning and once before bed.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-01-30
• Completion: 2019-01-30
• First posted: 2018-01-23
• Last updated: 2019-05-17

Regulatory

• FDA-regulated drug study