Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

January 31, 2015

Study Completion Date

March 31, 2015

Conditions
Dry Eye SyndromesKeratoconjunctivitis Sicca
Interventions
DRUG

KPI-121

KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.

DRUG

Placebo

Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.

Trial Locations (11)

11793

South Shore Eye Center, LLP, Wantagh

38119

Total Eye Care, PA, Memphis

44115

Abrams Eye Center, Cleveland

46260

Price Vision Group, Indianapolis

63090

Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC, Washington

63131

Ophthalmology Associates, St Louis

77055

Whitsett Vision Group, Houston

90701

Sall Research Medical Center, Artesia

91345

North Valley Eye Medical Group, Mission Hills

95670

Martel Eye Medical Group, Rancho Cordova

06518

Eye Center of Southern CT, P.C., Hamden

Sponsors
All Listed Sponsors
lead

Kala Pharmaceuticals, Inc.

INDUSTRY