20 completed, 6 withdrawn, 2 not yet recruiting, 2 recruiting. 16 Phase 4, 6 Phase 2, 6 Phase 3, 2 Phase 1, 1 Early Phase 1.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Clinical Evaluation of Lifitegrast Ophthalmic Solution 5.0% in Dry Eye Disease Using In Vivo Confocal Microscopy Lifitegrast Ophthalmic Solution 5.0% (Xiidra) - Dry Eye | Phase 4 | Not yet recruiting | Toyos Clinic | 30 | 2026-04-01 | 2026-05-01 |
| This is a Single Center, Open-label Prospective Study to Evaluate the Effect of Xiidra® (Lifitegrast Ophthalmic Solution 5.0%) on Tear Film Biomarkers in Dry Eye (Xiidra®) Lifitegrast Ophthalmic Solution 5.0% - Ocular Surface Disease, Dry Eye Syndrome (DES) | Phase 4 | Not yet recruiting | Pittsburgh Research Institute | 36 | 2026-03-01 | 2026-03-24 |
| A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease Lifitegrast/perfluorohexyloctane (PFHO) - Dry Eye Disease | Phase 3 | Withdrawn | Bausch & Lomb Incorporated | 2025-12-01 | 2025-12-10 | |
| A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease Lifitegrast/Perfluorohexyloctane Fixed Dose Combination, Lifitegrast, Perfluorohexyloctane - Dry Eye Disease | Phase 2 | Completed | Bausch & Lomb Incorporated | 443 | 2025-10-24 | 2026-07-14 |
| A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment Vevye®, Xiidra® - Dry Eye Disease | Phase 4 | Completed | Hoffmann-La Roche | 378 | 2025-07-09 | 2026-07-27 |
| Phase III Clinical Study of Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease Drug placebo - Dry Eye Disease (DED) | Phase 3 | Recruiting | Lunan Better Pharmaceutical Co., LTD. | 820 | 2024-03-28 | 2025-03-17 |
| Examining the Clinical Characteristics, Treatment Patterns, Real-world Effectiveness, and Healthcare Resource Utilization of Patients With Dry Eye Disease lifitegrast - Dry Eye Disease | Withdrawn | Novartis Pharmaceuticals | 2023-07-31 | 2023-09-01 | ||
| Lifitegrast Eye Drops in Healthy Subjects：Phase I Study Xiidra, Lifitegrast - Dry Eye Syndromes | Phase 1 | Completed | Qilu Pharmaceutical Co., Ltd. | 24 | 2022-12-06 | 2025-06-27 |
| The Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease Lifitegrast 5% Ophthalmic Solution, Placebo - Graft-versus-host-disease, Ocular Graft-versus-host Disease | Early Phase 1 | Completed | Richard W Yee, MD | 30 | 2022-10-22 | 2024-07-15 |
| Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers Lifitegrast 5% Ophthalmic Solution, Lifitegrast Ophthalmic Solution Vehicle - Dry Eye | Phase 4 | Completed | State University of New York College of Optometry | 32 | 2022-09-22 | 2025-01-14 |
| An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber Reproxalap Ophthalmic Solution (0.25%), Xiidra® (5% lifitegrast ophthalmic solution) - Dry Eye | Phase 2 | Completed | Aldeyra Therapeutics, Inc. | 56 | 2021-09-09 | 2025-02-28 |
| The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers Xiidra - Dry Eye | Phase 4 | Completed | University of Waterloo | 45 | 2021-07-07 | 2025-05-04 |
| Ocular Inflammation in Cataract Patients and Response to Treatment With Xiidra Lifitegrast 5% Ophthalmic Solution - Dry Eye | Phase 4 | Withdrawn | Bucci Laser Vision Institute | 2021-05-31 | 2023-07-27 | |
| Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications Xiidra (Lifitegrast ophthalmic solution) 5% - Glaucoma, Ocular Surface Disease | Recruiting | University of California, Los Angeles | 75 | 2021-04-01 | 2026-03-13 | |
| The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study Lifitegrast 5% Ophthalmic Solution - Dry Eye | Phase 4 | Completed | Research Insight LLC | 100 | 2021-03-17 | 2021-10-12 |
| Treatment Regimens in Meibomian Gland Dysfunction Lifitegrast Ophthalmic, Systane Free, Lipiflow - Dry Eye Syndromes | Phase 4 | Completed | Tauber Eye Center | 60 | 2021-03-02 | 2023-04-12 |
| Effect of Lifitegrast 5% on Tear Film Markers Lifitegrast 5% Ophthalmic Solution - Dry Eye, Dry Eye Syndromes | Phase 4 | Withdrawn | Weill Medical College of Cornell University | 2021-03-01 | 2021-02-16 | |
| Efficacy of Xiidra in Dry Eye Disease After Collagen Cross Linking Xiidra 5% Ophthalmic Solution - Corneal Disease | Phase 4 | Unknown | Benha University | 40 | 2021-02-01 | 2021-09-16 |
| A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate), Mycophenolic Acid 0.1%, Mycophenolic Acid 0.3% - Dry Eye Disease | Phase 2 | Completed | Surface Ophthalmics, Inc. | 349 | 2021-01-11 | 2025-05-11 |
| Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease Lifitegrast 5% Ophthalmic Solution, Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution - Dry Eye Syndromes | Phase 4 | Terminated | Eye Surgeons of Indiana | 5 | 2020-08-01 | 2026-10-27 |
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Dry Eye Syndromes (31) · Keratoconjunctivitis Sicca (3) · Cataract (1) · Conjunctivitis, Allergic (1) · Corneal Diseases (1) · Glaucoma (1) · Graft vs Host Disease (1) · Xerophthalmia (1)
Shire (6) · Bausch & Lomb Incorporated (2) · Toyos Clinic (2) · University of Alabama at Birmingham (2) · AbbVie (1) · Aldeyra Therapeutics, Inc. (1) · Benha University (1) · BioTissue Holdings, Inc (1) · Bucci Laser Vision Institute (1) · EV Clinical Trials (1) · Eye Surgeons of Indiana (1) · Hoffmann-La Roche (1) · Lifelong Vision Foundation (1) · Lunan Better Pharmaceutical Co., LTD. (1) · MDbackline, LLC (1)
United States (26) · Canada (2) · China (2) · United Arab Emirates (1)
Christopher Starr, MD (1) · Damon Dierker, OD, FAAO (1) · Danielle Iacono, OD (1) · Frank A Bucci, Jr., MD (1) · Jason J Nichols, OD PhD MPH (1) · Jay S Pepose, MD, PhD (1) · John Hovanesian, MD (1) · Kamran Hosseini, MD, PhD (1) · Kelly K Nichols, OD MPH PhD (1) · Leanne T Labriola, DO, MBA (1) · Lyndon Jones, PhD, FCOptom (1) · Melissa Toyos, MD (1)
PMID 27055211, PMID 17102664, PMID 21450919, PMID 22330307, PMID 22475641, PMID 24289915, PMID 26365210, PMID 27388660, PMID 28079022, PMID 34617974, PMID 42704415