CLINICAL TRIALS PROFILE FOR LIFITEGRAST
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All Clinical Trials for Lifitegrast
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00882687 ↗ | Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis | Completed | Shire | Phase 2 | 2009-04-24 | The purpose of this study is to determine whether SAR 1118 at three different concentrations, compared to placebo, is effective in the prevention of the signs and symptoms of allergic conjunctivitis |
| NCT00926185 ↗ | A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE) | Completed | Shire | Phase 2 | 2009-08-03 | The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye. |
| NCT01421498 ↗ | Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1) | Completed | Shire | Phase 3 | 2011-08-29 | The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated. |
| NCT01636206 ↗ | Safety Study of Lifitegrast to Treat Dry Eye | Completed | Shire | Phase 3 | 2012-10-16 | The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year. |
| NCT01743729 ↗ | A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye | Completed | Shire | Phase 3 | 2012-12-07 | The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye. |
| NCT02284516 ↗ | A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3) | Completed | Shire | Phase 3 | 2014-11-06 | Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use. |
| NCT03408015 ↗ | Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease | Withdrawn | Shire | Phase 4 | 2019-01-01 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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