MedPath

Lifitegrast

Generic Name
Lifitegrast
Brand Names
Xiidra
Drug Type
Small Molecule
Chemical Formula
C29H24Cl2N2O7S
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)

A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)

Phase 3
Completed
Conditions
Dry Eye Disease
Interventions
Drug: Placebo
First Posted Date
2014-11-06
Last Posted Date
2021-06-11
Lead Sponsor
Shire
Target Recruit Count
711
Registration Number
NCT02284516
Locations
🇺🇸

Chicago Cornea Consultants, Ltd., Hoffman Estates, Illinois, United States

🇺🇸

Jackson Eye, SC, Lake Villa, Illinois, United States

🇺🇸

Lifelong Vision Foundation, Chesterfield, Missouri, United States

and more 38 locations

A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye

Phase 3
Completed
Conditions
Dry Eye Disease
Interventions
Drug: Placebo
First Posted Date
2012-12-06
Last Posted Date
2021-06-23
Lead Sponsor
Shire
Target Recruit Count
720
Registration Number
NCT01743729
Locations
🇺🇸

OPUS-2 Investigational Site, Norfolk, Virginia, United States

🇺🇸

OPUS-2 Investigational SIte, Rancho Cordova, California, United States

Safety Study of Lifitegrast to Treat Dry Eye

Phase 3
Completed
Conditions
Dry Eye Disease
Interventions
Drug: Placebo
First Posted Date
2012-07-10
Last Posted Date
2021-06-11
Lead Sponsor
Shire
Target Recruit Count
332
Registration Number
NCT01636206
Locations
🇺🇸

SONATA Investigational Site, Houston, Texas, United States

Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)

Phase 3
Completed
Conditions
Keratoconjunctivitis Sicca
Dry Eye Disease
Interventions
Drug: Placebo
First Posted Date
2011-08-22
Last Posted Date
2021-06-11
Lead Sponsor
Shire
Target Recruit Count
588
Registration Number
NCT01421498
Locations
🇺🇸

OPUS-1 Investigational Site, Norfolk, Virginia, United States

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)

Phase 2
Completed
Conditions
Dry Eye
Interventions
Drug: Placebo
First Posted Date
2009-06-23
Last Posted Date
2021-08-09
Lead Sponsor
Shire
Target Recruit Count
230
Registration Number
NCT00926185
Locations
🇺🇸

Mundorf Eye Center, Charlotte, North Carolina, United States

🇺🇸

The Eye Care Group, Waterbury, Connecticut, United States

🇺🇸

Central Maine Eye Care, Lewiston, Maine, United States

and more 2 locations

Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis

Phase 2
Completed
Conditions
Allergic Conjunctivitis
Interventions
Other: Placebo
First Posted Date
2009-04-16
Last Posted Date
2021-06-11
Lead Sponsor
Shire
Target Recruit Count
60
Registration Number
NCT00882687
Locations
🇺🇸

Ora, Andover, Massachusetts, United States

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