Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation

PHASE3CompletedINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Ocular Infections, Irritations and Inflammations
Interventions
DRUG

KPI-121 0.25%

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

KPI-121 1.0%

KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.

DRUG

Vehicle of KPI-121 0.25%

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

DRUG

Vehicle of KPI-121 1.0%

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

Trial Locations (23)

10013

Raymond Fong, MDPC, New York

14618

Rochester Ophthalmological Group, PC, Rochester

23502

Virginia Eye Consultants, Norfolk

27262

Cornerstone Eye Care, High Point

29306

Westside Research, LLC, Spartanburg

30260

Clayton Eye Center, Morrow

40217

Taustine Eye Center, Louisville

43215

The Eye Center of Columbus, Columbus

45242

Cincinnati Eye Institute, Cincinnati

46260

Price Vision Group, Indianapolis

47150

John-Kenyon American Eye Institute, New Albany

63128

Tekwani Vision Center, St Louis

63131

Ophthalmology Associates, St Louis

Ophthalmology Consultants, St Louis

64111

Tauber Eye Center, Kansas City

77573

The Eye Clinic of Texas, Affiliate of Houston Eye Associates, League City

78229

R&R Eye Research, LLC, San Antonio

78230

Kozlovsky Delay & Winter Eye Consultants, LLC, San Antonio

89052

Las Vegas Physicians Research Group, Henderson

90505

Wolstan & Goldberg Eye Associates, Torrance

90701

Sall Research Medical Center, Artesia

91345

North Valley Eye Medical Group, Mission Hills

95670

Martel Eye Medical Group, Rancho Cordova

Sponsors
All Listed Sponsors
lead

Kala Pharmaceuticals, Inc.

INDUSTRY

NCT02163824 - Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation | Biotech Hunter | Biotech Hunter