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

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ClinicalTrials.gov Identifier: NCT02218489
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Kala Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Blepharitis Drug: KPI-121 Drug: Vehicle Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : July 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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:
  • KPI-121 0.25% Vehicle
  • Placebo

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:
  • KPI-121 0.25% Ophthalmic Suspension
  • Loteprednol etabonate




Primary Outcome Measures :
  1. Posterior Lid Margin Hyperemia [ Time Frame: Day 29 ]
    Comparison of posterior lid margin hyperemia between the KPI-121 0.25% ophthalmic suspension group and the vehicle group

  2. Ocular Discomfort [ Time Frame: Day 22 to Day 29 ]
    Comparison of ocular discomfort between the KPI-121 0.25% ophthalmic suspension group and the vehicle group



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218489


Locations
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United States, Alabama
UAB School of Optometry
Birmingham, Alabama, United States, 35294-0010
United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
Wolstan & Goldberg Eye Associates
Torrance, California, United States, 90505
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
United States, New York
South Shore Eye Center, LLP
Wantagh, New York, United States, 11793
United States, Ohio
Abrams Eye Center
Cleveland, Ohio, United States, 44115
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Kala Pharmaceuticals, Inc.
Investigators
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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: Steven Rauchman, MD North Valley Eye Medical Group
Principal Investigator: Kenneth Sall, MD Sall Research Medical Center
Principal Investigator: John Sheppard, MD Virginia Eye Consultants
Principal Investigator: Joseph Tauber, MD Tauber Eye Center

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Responsible Party: Kala Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02218489     History of Changes
Other Study ID Numbers: KPI-121-C-003
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Keywords provided by Kala Pharmaceuticals, Inc.:
Pain
Corticosteroid
Meibomian Gland Disease
Blepharitis
Eyelid
Ocular Discomfort
Additional relevant MeSH terms:
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Blepharitis
Eyelid Diseases
Eye Diseases
Loteprednol Etabonate
Anti-Allergic Agents