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

NCT02218489 | Completed Phase 2 Results

• 1 other identifier: KPI-121-C-003
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 8

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.

Conditions

Blepharitis

Keywords

Pain; Corticosteroid; Meibomian Gland Disease; Blepharitis; Eyelid; Ocular Discomfort

Outcome Measures

Primary Outcomes (2)

• 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 1. mild 2. moderate 3. severe 4. very severe

  Visit 2 (Day 1) to Visit 4 (Day 15)

Secondary Outcomes (4)

• Change From Baseline in Ocular Discomfort

  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

  Visit 2 (Day 1) to Visit 6 (Day 29)

• Change From Baseline in Posterior Lid Margin Hyperemia

  Visit 2 (Day 1) to Visit 4 (Day 15)

• Change From Baseline in Posterior Lid Margin Hyperemia

  Visit 2 (Day 1) to Visit 6 (Day 29)

Study Arms (2)

Vehicle

PLACEBO COMPARATOR

Vehicle (placebo) dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease

Drug: Vehicle

KPI-121 0.25% Ophthalmic Suspension

ACTIVE COMPARATOR

KPI-121 0.25% Ophthalmic Suspension dosed QID for up to 30 days in subjects with inflammatory meibomian gland disease

Drug: KPI-121

Interventions

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.

Also known as: KPI-121 0.25% Ophthalmic Suspension, Loteprednol etabonate

KPI-121 0.25% Ophthalmic Suspension

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.

Also known as: KPI-121 0.25% Vehicle, Placebo

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kala Pharmaceuticals, Inc.: lead

Study Sites (8)

UAB School of Optometry

Birmingham, Alabama, 35294-0010, United States

Location

Sall Research Medical Center

Artesia, California, 90701, United States

Location

North Valley Eye Medical Group

Mission Hills, California, 91345, United States

Location

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

South Shore Eye Center, LLP

Wantagh, New York, 11793, United States

Location

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Blepharitis; Pain; Meibomian Gland Dysfunction

Interventions

Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: VP, Clinical Development
• Organization: Kala Pharmaceuticals, Inc

Results003@kalarx.com

781-996-5252

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 18, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: January 11, 2021
• Results First Posted: January 11, 2021

Record last verified: 2021-01

Locations

US (8)