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

A Phase II, Double-Masked, Randomized, Vehicle-Controlled Study to Evaluate the Effect of KPI-121 0.25% Ophthalmic Suspension on Signs and Symptoms of Inflammatory Meibomian Gland Disease

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.

Study Overview

• Status: Completed
• Conditions: Blepharitis
• Intervention / Treatment: Drug: Vehicle; Drug: KPI-121

Detailed Description

This is a Phase II, multicenter, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 ophthalmic suspension versus vehicle in subjects with signs and symptoms of inflammatory meibomian gland disease. The product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (QID).

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0010
      • UAB School of Optometry
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group
    • Torrance, California, United States, 90505
      • Wolstan & Goldberg Eye Associates
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Tauber Eye Center
  • New York
    • Wantagh, New York, United States, 11793
      • South Shore Eye Center, LLP
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes.

Exclusion Criteria:

• Known hypersensitivity/contraindication to study product(s) or components.
• Be currently receiving treatment for glaucoma, have history of or current glaucoma, or an IOP (intraocular pressure) over 21mmHg at Visit 1 (Screening) or Visit 2 (Randomization).
• Be unwilling to discontinue warm compress therapy, lid expression, or lid massage 14 days prior to Day 1 and for the duration of the study.
• Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening.
• Have had ocular surgery in the past 90 days or require ocular surgery during the study.
• In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle; Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease	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.; Other Names: Placebo; KPI-121 0.25% Vehicle
Active Comparator: KPI-121 0.25% Ophthalmic Suspension; KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease	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.; Other Names: Loteprednol etabonate; KPI-121 0.25% Ophthalmic Suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Ocular Discomfort	Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 4 (Day 15).	Visit 2 (Day 1) to Visit 4 (Day 15)
Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline	Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in subjects with greater baseline hyperemia at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description: 0=normal; mild; moderate; severe; very severe	Visit 2 (Day 1) to Visit 4 (Day 15)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Ocular Discomfort	Comparison of change from baseline in ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group using a 0-100 visual analog grading scale where 0 was better and 100 was worse at Visit 6 (Day 29).	Visit 2 (Day 1) to Visit 6 (Day 29)
Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline	Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group in the subgroup of subjects with greater hyperemia at baseline at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description: 0=normal; mild; moderate; severe; very severe	Visit 2 (Day 1) to Visit 6 (Day 29)
Change From Baseline in Posterior Lid Margin Hyperemia	Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 4 (Day 15). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description: 0=normal; mild; moderate; severe; very severe	Visit 2 (Day 1) to Visit 4 (Day 15)
Change From Baseline in Posterior Lid Margin Hyperemia	Comparison of change from baseline in posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group at Visit 6 (Day 29). The scale for posterior lid margin hyperemia was scored on a range from 0-4 with the following description: 0=normal; mild; moderate; severe; very severe	Visit 2 (Day 1) to Visit 6 (Day 29)

Collaborators and Investigators

• Sponsor: Kala Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Steven Rauchman, MD, North Valley Eye Medical Group; Principal Investigator: Kenneth Sall, MD, Sall Research Medical Center; Principal Investigator: Marc Abrams, MD, Abrams Eye Center; Principal Investigator: Damien Goldberg, MD, Wolstan & Goldberg Eye Associates; Principal Investigator: Jodi Luchs, MD, South Shore Eye Center, LLP; Principal Investigator: Kelly Nichols, OD, PhD, UAB School of Optometry; Principal Investigator: Joseph Tauber, MD, Tauber Eye Center

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 14, 2014
• First Posted (Estimate): August 18, 2014

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Corticosteroid; Eyelid; Ocular Discomfort; Blepharitis; Meibomian Gland Disease
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Blepharitis; Anti-Allergic Agents; Loteprednol Etabonate
• Other Study ID Numbers: KPI-121-C-003