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

Blepharitis Clinical Trial

— Maui  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218489
• Other study ID #: KPI-121-C-003
• Status: Completed
• Phase: Phase 2
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2021
• Source: Kala Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blepharitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Sall Research Medical Center	Artesia	California
United States	UAB School of Optometry	Birmingham	Alabama
United States	Abrams Eye Center	Cleveland	Ohio
United States	Tauber Eye Center	Kansas City	Missouri
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Wolstan & Goldberg Eye Associates	Torrance	California
United States	South Shore Eye Center, LLP	Wantagh	New York

Sponsors (1)

Lead Sponsor	Collaborator
Kala Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)