NCT01421498View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

588

Participants

Timeline

Start Date

August 29, 2011

Primary Completion Date

April 28, 2012

Study Completion Date

April 28, 2012

Conditions
Keratoconjunctivitis SiccaDry Eye Disease
Interventions
DRUG

Lifitegrast

Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks

DRUG

Placebo

Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks

Trial Locations (13)

23502

OPUS-1 Investigational Site, Norfolk

38119

OPUS-1 Investigational Site, Memphis

40405

OPUS-1 Investigational Site, Louisville

06708

OPUS-1 Investigational Site, Waterbury

04330

OPUS-1 Investigational Site, Augusta

04243

OPUS-1 Investigational Site, Lewiston

01840

OPUS-1 Investigational Site, Andover

01523

OPUS-1 Investigational Site, Lancaster

02169

OPUS-1 Investigational Site, Quincy

01880

OPUS-1 Investigational Site, Wakefield

01890

OPUS-1 Investigational Site, Winchester

03038

OPUS-1 Investigational Site, Derry

03101

OPUS-1 Investigational Site, Manchester

Sponsors

Lead Sponsor

Shire
All Listed Sponsors
lead

Shire

INDUSTRY

NCT01421498 - Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1) | Biotech Hunter | Biotech Hunter