A Phase 4 interventional study of Lifitegrast in Ocular Discomfort, Ocular Inflammation and Dry Eye, sponsored by University of Alabama at Birmingham. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-17.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Basic science
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.
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
Browse Keratoconjunctivitis Sicca studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Compared within Keratoconjunctivitis Sicca, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dry Eye Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Drug: Lifitegrast
Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Drug: Lifitegrast
Lifitegrast ophthalmic solution, 5.0%. Dosage: 1 drop in each eye, twice daily: once in the morning and once before bed.
Drug: Lifitegrast
Lifitegrast ophthalmic solution, 5.0%. 1 drop instilled into each eye once in the morning and once before bed.
Also known as: Xiidra
Change from baseline in the total number of T cells recovered from the closed eye to day 84
Subjects will be trained and required to collect their closed eye tears at home, using a gentle saline rinse of the ocular surface. Enumeration of recovered T cells will be performed by flow cytometry.
Time frame: Baseline to day 84
Change from baseline in the total number of neutrophils recovered from the closed eye to day 84.
Subjects will be trained and required to collect their closed eye tears at home, using a gentle saline rinse of the ocular surface. Enumeration of recovered neutrophils will be performed by flow cytometry.
Time frame: Baseline to day 84.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lifitegrast
University of Alabama at Birmingham →