Safety and Efficacy of KPI-121 in Subjects With Inflammatory Meibomian Gland Disease - Clinical Trial for Blepharitis | NCT02218489

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

KPI-121

Vehicle

About this trial

This is an interventional treatment trial for Blepharitis focused on measuring Pain, Corticosteroid, Meibomian Gland Disease, Blepharitis, Eyelid, Ocular Discomfort

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Vehicle

KPI-121 0.25% Ophthalmic Suspension

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

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

Secondary Outcome Measures

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).

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

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

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

Full Information

NCT ID

NCT02218489

First Posted

August 13, 2014

Last Updated

January 6, 2021

Sponsor

Kala Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02218489

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kala Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Blepharitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

206 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

KPI-121 0.25% Ophthalmic Suspension

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

KPI-121

Other Intervention Name(s)

KPI-121 0.25% Ophthalmic Suspension, Loteprednol etabonate

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Vehicle

Other Intervention Name(s)

KPI-121 0.25% Vehicle, Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change From Baseline in Ocular Discomfort

Description

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).

Time Frame

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

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Change From Baseline in Ocular Discomfort

Description

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).

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

Change From Baseline in Posterior Lid Margin Hyperemia

Description

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

Time Frame

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

Title

Change From Baseline in Posterior Lid Margin Hyperemia

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials: