MedTrace Logo

Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease

NCT02218489 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2021-01-11

Study results available
· View outcomes & findings →

Summary

The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of inflammatory meibomian gland disease.

Conditions

  • Blepharitis

Interventions

DRUG

KPI-121

KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm 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.

DRUG

Vehicle

The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.

Sponsors & Collaborators

  • Kala Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Marc Abrams, MD · Abrams Eye Center

  • Damien Goldberg, MD · Wolstan & Goldberg Eye Associates

  • Jodi Luchs, MD · South Shore Eye Center, LLP

  • Kelly Nichols, OD, PhD · UAB School of Optometry

  • Steven Rauchman, MD · North Valley Eye Medical Group

  • Kenneth Sall, MD · Sall Research Medical Center

  • John Sheppard, MD · Virginia Eye Consultants

  • Joseph Tauber, MD · Tauber 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
2014-07-31
Primary Completion
2015-12-31
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02218489 on ClinicalTrials.gov