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

Summary

The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).

Conditions

• Dry Eye Syndromes
• Keratoconjunctivitis 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.

Sponsors & Collaborators

• Kala Pharmaceuticals, Inc.

  lead INDUSTRY

Principal Investigators

• Gregg Berdy, MD · Ophthalmology Associates

• David Evans, OD · Total Eye Care, PA

• Kathy Kelley, OD · Price Vision Group

• Joseph Martel, MD · Martel Eye Medical Group

• Mark Milner, MD · Eye Center of Southern CT, P.C.

• Steven Rauchman, MD · North Valley Eye Medical Group

• Kenneth Sall, MD · Sall Research Medical Center

• Jeffrey Whitsett, MD · Whitsett Vision Group

• Marc Abrams, MD · Abrams Eye Center

• Michael Korenfeld, MD · Ecomprehensive Eye Care, Ltd / Vision Research Institute LLC

• Jodi Luchs, MD · South Shore Eye Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2015-01-31

Completion

2015-03-31

Countries

• United States

Study Locations