Clinical Trials

Numerous clinical trials spanning Early Phase 1 through post-marketing Phase 4 evaluate lifitegrast across ophthalmic conditions, primarily focusing on dry eye disease, allergic conjunctivitis, diabetic macular edema, contact lens discomfort, and ocular graft-versus-host disease. Supported by academic institutions like Johns Hopkins University and major pharmaceutical sponsors including Novartis, Shire, AbbVie, and Qilu Pharmaceutical, these protocols investigate safety, pharmacokinetics, and efficacy regarding ocular surface inflammation and discomfort. Across these registered studies, recruitment statuses vary and include completed, recruiting, terminated, and withdrawn trials.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07111013 WITHDRAWN
Dry Eye Disease
Bausch & Lomb Incorporated
 2025-12 PHASE3
NCT07490535 NOT_YET_RECRUITING
Ocular Surface Disease; Dry Eye Syndrome (DES)
Pittsburgh Research Institute
 2026-03 PHASE4
NCT07560735 NOT_YET_RECRUITING
Dry Eye
Toyos Clinic
 2026-04 PHASE4
NCT07128628 COMPLETED
Dry Eye Disease
Bausch & Lomb Incorporated
 2025-10-24 PHASE2
NCT06879782 RECRUITING
Dry Eye Disease (DED)
Lunan Better Pharmaceutical Co., LTD.
 2024-03-28 PHASE3
NCT04792580 COMPLETED
Graft-versus-host-disease; Ocular Graft-versus-host Disease
Richard W Yee, MD
 2022-10-22 EARLY_PHASE1
NCT05857748 Withdrawn
Dry Eye Disease
Novartis Pharmaceuticals|Novartis
 2023-07-31 --
NCT05505292 COMPLETED
Dry Eye
State University of New York College of Optometry
 2022-09-22 PHASE4
NCT05594745 COMPLETED
Dry Eye Syndromes
Tauber Eye Center
 2021-03-02 PHASE4
NCT07040826 COMPLETED
Dry Eye Syndromes
Qilu Pharmaceutical Co., Ltd.
 2022-12-06 PHASE1
NCT04172961 UNKNOWN
Dry Eye
Toyos Clinic
 2020-02-01 PHASE4
NCT04120987 WITHDRAWN
Dry Eye
Bucci Laser Vision Institute
 2021-05-31 PHASE4
NCT04413253 TERMINATED
Dry Eye Syndromes
Eye Surgeons of Indiana
 2020-08-01 PHASE4
NCT04734197 COMPLETED
Dry Eye Disease
Surface Ophthalmics, Inc.
 2021-01-11 PHASE2
NCT04030962 COMPLETED
Dry Eye Disease; Dry Eye Syndrome
AbbVie
 2020-03-04 PHASE1; PHASE2
NCT03952481 WITHDRAWN
Dry Eye; Dry Eye Syndromes; Dry Eyes Chronic
Weill Medical College of Cornell University
 2021-03-01 PHASE4
NCT05102409 COMPLETED
Dry Eye
Aldeyra Therapeutics, Inc.
 2021-09-09 PHASE2
NCT04669561 COMPLETED
Dry Eye
Research Insight LLC
 2021-03-17 PHASE4
NCT04015219 TERMINATED
Dry Eye Syndromes
BioTissue Holdings, Inc
 2018-07-18
NCT03691636 UNKNOWN
Dry Eye
D.E.L., LLC
 2018-10-02
NCT03408015 WITHDRAWN
Ocular Discomfort; Ocular Inflammation; Dry Eye; Contact Lens Complication; Keratoconjunctivitis Sicca
University of Alabama at Birmingham
 2019-01 PHASE4
NCT03431272 WITHDRAWN
Contact Lens Dry Eye
University of Alabama at Birmingham
 2018-11-01 PHASE4
NCT03866629 Completed
Dry Eye
MDbackline LLC
 2018-12-20 --
NCT03451396 COMPLETED
Dry Eye
Lifelong Vision Foundation
 2016-12-12 PHASE4
NCT03686878 COMPLETED
Contact Lens; Contact Lens Discomfort; Contact Lens Dryness
EV Clinical Trials
 2016-12-16 PHASE4
NCT02284516 COMPLETED
Dry Eye Disease
Shire
 2014-11-06 PHASE3
NCT01636206 COMPLETED
Dry Eye Disease
Shire
 2012-10-16 PHASE3
NCT01743729 COMPLETED
Dry Eye Disease
Shire
 2012-12-07 PHASE3
NCT01421498 COMPLETED
Keratoconjunctivitis Sicca; Dry Eye Disease
Shire
 2011-08-29 PHASE3
NCT00926185 COMPLETED
Dry Eye
Shire
 2009-08-03 PHASE2
NCT00936520 Terminated
Diabetic Macular Edema (DME)|Pars Plana Vitrectomy
Johns Hopkins University|SARcode Bioscience
 2009-08 Phase 1
NCT00882687 COMPLETED
Allergic Conjunctivitis
Shire
 2009-04-24 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-12-10)

Check the Lifitegrast product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lifitegrast functions as a small-molecule integrin antagonist that specifically binds to lymphocyte function-associated antigen-1, thereby blocking its interaction with intercellular adhesion molecule-1 and inhibiting T-cell adhesion and activation. By suppressing downstream T-cell-mediated inflammatory pathways and cytokine release, this inhibition reduces ocular surface inflammation to alleviate clinical symptoms associated with dry eye disease and related inflammatory ocular conditions.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.