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Completed

NCT Number: NCT02218489

Safety and Efficacy of KPI-121 in Subjects With 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.

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Key information

Conditions

Blepharitis Eye Diseases Eyelid Diseases Meibomian Gland Dysfunction Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UAB School of Optometry, Birmingham, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KPI-121

Drug

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: KPI-121 0.25% Ophthalmic Suspension, Loteprednol etabonate

Vehicle

Drug

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: KPI-121 0.25% Vehicle, Placebo

Primary outcomes

  1. Change From Baseline in Ocular Discomfort

    Time frame: Visit 2 (Day 1) to Visit 4 (Day 15)

    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).

  2. Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline

    Time frame: Visit 2 (Day 1) to Visit 4 (Day 15)

    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

Secondary outcomes

  1. Change From Baseline in Ocular Discomfort

    Time frame: Visit 2 (Day 1) to Visit 6 (Day 29)

    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).

  2. Change From Baseline in Posterior Lid Margin Hyperemia in the Subgroup of Subjects With Greater Hyperemia at Baseline

    Time frame: Visit 2 (Day 1) to Visit 6 (Day 29)

    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

  3. Change From Baseline in Posterior Lid Margin Hyperemia

    Time frame: Visit 2 (Day 1) to Visit 4 (Day 15)

    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

  4. Change From Baseline in Posterior Lid Margin Hyperemia

    Time frame: Visit 2 (Day 1) to Visit 6 (Day 29)

    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

Sponsors and collaborators

Lead sponsor

Kala Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: Maui

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 18, 2014
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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