Lifitegrast

Generic Name: Lifitegrast

Brand Names: Xiidra

Drug Type: Small Molecule

Chemical Formula: C_₂₉H_₂₄Cl_₂N_₂O_₇S

CAS Number: 1025967-78-5

Unique Ingredient Identifier: 038E5L962W

Background: Lifitegrast is a FDA approved drug for the treatment of keratoconjunctivitis sicca (dry eye syndrome). It is a tetrahydroisoquinoline derivative and lymphocyte function-associated antigen-1 ( LFA-1) antagonist that was discovered through the rational design process. The ophthalmic solution was approved in July, 2016 under the trade name Xiidra. It has shown to protect the corneal surface and alleviate the symptoms of dry eye syndrome with fast onset of action and well tolerated profile in both local and systemic setting .

Indication: 适用于治疗干眼病（DED）的症状和体征。

Associated Conditions: Dry Eye Syndrome (DES)

Clinical Trials

Examining the Clinical Characteristics, Treatment Patterns, Real-world Effectiveness, and Healthcare Resource Utilization of Patients With Dry Eye Disease

Withdrawn

Conditions: Dry Eye Disease

Interventions: Drug: lifitegrast

First Posted Date: 2023-05-15

Last Posted Date: 2023-09-01

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT05857748

Treatment Regimens in Meibomian Gland Dysfunction

Phase 4

Completed

Conditions: Dry Eye Syndromes

Interventions: Drug: Lifitegrast Ophthalmic
Drug: Systane Free
Device: Lipiflow

First Posted Date: 2022-10-26

Last Posted Date: 2023-04-12

Lead Sponsor: Tauber Eye Center

Target Recruit Count: 60

Registration Number: NCT05594745

Locations: 🇺🇸
joseph Tauber, Kansas City, Missouri, United States

Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers

Phase 4

Completed

Conditions: Dry Eye

Interventions: Other: Lifitegrast Ophthalmic Solution Vehicle
Drug: Lifitegrast 5% Ophthalmic Solution

First Posted Date: 2022-08-17

Last Posted Date: 2025-01-14

Lead Sponsor: State University of New York College of Optometry

Target Recruit Count: 32

Registration Number: NCT05505292

Locations: 🇺🇸
State University of New York College of Optometry Clinical Vision Research Center, New York, New York, United States

An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber

Phase 2

Completed

Conditions: Dry Eye

Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%)
Drug: Xiidra® (5% lifitegrast ophthalmic solution)

First Posted Date: 2021-11-01

Last Posted Date: 2025-02-28

Lead Sponsor: Aldeyra Therapeutics, Inc.

Target Recruit Count: 56

Registration Number: NCT05102409

Locations: 🇨🇦
Cliantha Research, Mississauga, Ontario, Canada

Efficacy of Xiidra in Dry Eye Disease After Collagen Cross Linking

Phase 4

Conditions: Corneal Disease

Interventions: Drug: Xiidra 5% Ophthalmic Solution

First Posted Date: 2021-09-16

Last Posted Date: 2021-09-16

Lead Sponsor: Benha University

Target Recruit Count: 40

Registration Number: NCT05045053

Locations: 🇦🇪
INMC, Abu Dhabi, United Arab Emirates

The Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease

Early Phase 1

Completed

Conditions: Graft-versus-host-disease
Ocular Graft-versus-host Disease

Interventions: Drug: Lifitegrast 5% Ophthalmic Solution
Drug: Placebo

First Posted Date: 2021-03-11

Last Posted Date: 2024-07-15

Lead Sponsor: Richard W Yee, MD

Target Recruit Count: 30

Registration Number: NCT04792580

Locations: 🇺🇸
Richard W Yee, MD PLLC, Bellaire, Texas, United States

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

Phase 2

Completed

Conditions: Dry Eye Disease

Interventions: Drug: Betamethasone Sodium Phosphate 0.01%
Drug: SURF-100 (Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate)
Drug: Mycophenolic Acid 0.1%
Drug: Mycophenolic Acid 0.3%
Drug: Cyclosporine 0.05% Ophthalmic Emulsion
Drug: Lifitegrast 5% Ophthalmic Solution

First Posted Date: 2021-02-02

Last Posted Date: 2025-05-11

Lead Sponsor: Surface Ophthalmics, Inc.

Target Recruit Count: 349

Registration Number: NCT04734197

Locations: 🇺🇸
North Valley Eye Medical Group Inc., Mission Hills, California, United States
🇺🇸
LoBue Laser and Eye Medical Center, Murrieta, California, United States
🇺🇸
Martel Eye Medical Group, Rancho Cordova, California, United States

and more 37 locations

The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study

Phase 4

Completed

Conditions: Dry Eye

Interventions: Drug: Lifitegrast 5% Ophthalmic Solution

First Posted Date: 2020-12-17

Last Posted Date: 2021-10-12

Lead Sponsor: Research Insight LLC

Target Recruit Count: 100

Registration Number: NCT04669561

Locations: 🇺🇸
Harvard Eye Associates, Laguna Hills, California, United States
🇺🇸
Cleveland Eye Clinic, Brecksville, Ohio, United States
🇺🇸
Bowden Eye & Associates, Jacksonville, Florida, United States